Loading..

Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor

2022-06-27 20:30:00

Gilead Sciences, Inc. announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection. Gilead resubmitted the NDA in response to the FDA Complete Response Letter (CRL) issued in February 2022, which cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir in borosilicate vials as the reason for the FDA action. The NDA resubmission contains comprehensive CMC data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass. In addition, the NDA is supported by extensive pre-clinical and earlier clinical research data as well as data from the Phase 2/3 CAPELLA study, which evaluated the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral(s), in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. Once accepted by the FDA, a new Prescription Drug User Fee Act (PDUFA) date will be established. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.

Gilead Sciences, Inc. Announces Investigational Lenacapavir Receives Positive Chmp Opinion for People with Multi-Drug Resistant HIV

2022-06-24 12:00:00

Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for investigational lenacapavir for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. The CHMP positive opinion is a scientific recommendation to the European Commission (EC) to grant marketing authorization in Europe and will be reviewed by the EC, which has the authority to authorize medicines in the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. The final European Commission decision is expected later this year. The positive opinion is supported by data from the Phase 2/3 CAPELLA trial, a double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral(s), in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. In this patient population of high unmet medical need, 81% (n=29/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at Week 26. Additionally, CAPELLA participants achieved a mean increase in CD4 count of 81 cells/µL. The New England Journal of Medicine published the primary outcome results of the CAPELLA trial in its May 11, 2022 issue - Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. Through Week 26, lenacapavir was generally well tolerated, with no serious adverse events related to lenacapavir as determined by the study investigator. The most common adverse events observed in the trial were injection-site reactions. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS. Lenacapavir is Gilead’s potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment of HIV-1 infection. The safety, efficacy and dosing of Gilead’s investigational, long-acting HIV-1 capsid inhibitor lenacapavir are being evaluated in multiple ongoing clinical studies. Lenacapavir's multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes. If authorized, lenacapavir would be the only HIV-1 treatment option administered twice yearly. CAPELLA is a Phase 2/3, double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir administered every six months as a subcutaneous injection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. CAPELLA includes men and women with HIV-1 and is being conducted at research centers in North America, Europe and Asia. In CAPELLA, 36 participants with multi-class HIV-1 drug resistance and a detectable viral load while on a failing regimen were randomly allocated to receive oral lenacapavir or placebo in a 2:1 ratio for 14 days, in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled in a separate treatment cohort. Both cohorts are part of the ongoing maintenance period of the study evaluating the safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. The primary endpoint was the proportion of participants randomly allocated to receive lenacapavir or placebo for 14 days, in addition to continuing their failing regimen, achieving =0.5 log10 copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period. Following the 14-day functional monotherapy period, participants randomly allocated to receive lenacapavir or placebo, in addition to continuing their failing regimen, started open-label lenacapavir and an optimized background regimen, while those enrolled in a separate treatment cohort received open-label lenacapavir and an optimized background regimen on Day 1. This ongoing maintenance period of the study is evaluating the additional trial endpoints of safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen.

Gilead Sciences, Inc. Announces Week 48 Results from the Pivotal Phase 3 Clinical Trial Evaluating the First-In-Class Entry Inhibitor Hepcludex® (Bulevirtide) for the Treatment of Chronic Hepatitis Delta Virus (Hdv) Infection

2022-06-23 12:30:00

Gilead Sciences, Inc. announced Week 48 results from the Pivotal Phase 3 clinical trial evaluating the first-in-class entry inhibitor Hepcludex® (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. Findings from the study underscore the efficacy and safety of bulevirtide for the treatment of chronic HDV and are being presented in the International Liver Congress™ (ILC) 2022 Official Press Program. In addition, Week 48 data demonstrating the positive impact of bulevirtide on patient-reported outcomes (PROs) in people living with chronic HDV will also be presented. Together, these data reinforce the clinical utility of bulevirtide as monotherapy for the treatment of chronic HDV. There are currently no other approved treatment options for HDV and people living with HDV typically have a poor prognosis. At Week 48, study participants treated with bulevirtide monotherapy at 2 mg or 10 mg once daily achieved a significantly greater combined virological and biochemical response (45% and 48%, respectively) when compared to participants who had not received antiviral treatment at this stage of the study (2%). Combined response was defined as undetectable HDV RNA or a decrease by 2 log10 IU/mL from baseline and ALT normalization. Similarly, when the Week 48 data is considered alongside the integrated Week 24 analyses of the ongoing Phase 2 studies (MYR202 and MYR203) and the interim Week 24 Phase 3 MYR301 data presented at ILC 2021, combined response rates of bulevirtide increased from Week 24 to Week 48, highlighting an improved response of bulevirtide with prolonged treatment. The safety profile of bulevirtide at Week 48 is consistent with prior reports, with no participants having an adverse event (AE) leading to discontinuation of bulevirtide and no serious AEs attributed to bulevirtide treatment. The safety profile at both Week 24 and again at Week 48 reassert the safety and tolerability profile of bulevirtide, which is an important factor for people living with chronic HDV. In an oral presentation, Gilead will also share an exploratory analysis of the Week 48 data from the Phase 3 MYR301 study, evaluating the impact of bulevirtide (2 mg once daily) on PROs in people living with chronic HDV. Participants treated with bulevirtide 2 mg (n=49) showed significant improvements from baseline at 48 weeks in almost all assessed health-related quality-of-life domains of the Hepatitis Quality of Life questionnaire. Participants in the control group (n=51) remained largely unchanged, apart from significant improvements in health distress and hepatitis-specific health distress. Of note, participants receiving bulevirtide 2 mg reported significant improvements in performance of daily activities related to hepatitis, emotional impact of hepatitis and improvement in work compared with controls. Bulevirtide was granted Conditional Marketing Authorization by the European Commission and is an investigational agent in the U.S. and outside of the European Economic Area. In these regions, health authorities have not established the safety and efficacy of bulevirtide. A Biologics License Application (BLA) was submitted in Fourth Quarter 2021 to the U.S. Food and Drug Administration (FDA) for bulevirtide for injection (2 mg) to treat adults with HDV and compensated liver disease. This Phase 3 data is included in the filing of bulevirtide to the FDA. Bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA. In 2020 bulevirtide 2 mg was granted Conditional Marketing Authorization by the European Commission and PRIority MEdicines (PRIME) scheme eligibility by the European Medicines Agency as the first approved treatment in Europe for adults with chronic HDV and compensated liver disease. MYR301 is an ongoing Phase 3 clinical trial evaluating the long-term efficacy and safety of bulevirtide in 150 people living with chronic HDV randomly allocated to treatment with bulevirtide 2 mg once daily (n=49), 10 mg once daily (n=50) or no antiviral treatment (delayed treatment, n=51). Primary efficacy and safety data will be assessed at Week 48. After Week 48, participants in the delayed treatment group of the study will be switched to bulevirtide 10 mg once daily for an additional 96 weeks. The total duration of treatment across all groups in the study is 144 weeks. The primary endpoint, combined response, is defined as an undetectable HDV RNA (10 IU/ml decline from baseline and ALT normalization at Week 48. Secondary endpoints at Week 48 include undetectable HDV RNA (key secondary endpoint), ALT normalization, and a change from baseline in liver stiffness measured by transient elastography. Chronic HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within five years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have hepatitis B virus (HBV). It is estimated that at least 12 million people worldwide are currently co-infected with HDV and HBV. HDV co-infection is associated with a faster progression to liver fibrosis, cirrhosis and hepatic decompensation and an increased risk of liver cancer and death. In the U.S. and Europe, there are more than 230,000 people living with HDV; however, it remains underdiagnosed globally.

Gilead Sciences New Data Highlights People Living with Hiv Who Are Virally Suppressed Experience Similar Health-Related Quality of Life as General Population

2022-06-16 03:15:00

Gilead Sciences, Inc. announced results from an online survey that assessed the health-related quality of life (HRQOL) among people living with HIV (PLWH) in Taiwanwho are virally suppressed as compared to the general population. The data shows that those who are virally suppressed experience similar HRQOL as the general population and highlights the importance of evaluating an individual's quality of life, including both physical and mental health-related issues, beyond viral suppression. The findings will be presented at the virtual Asia-Pacific AIDS and Co-Infections Conference (APACC) 2022, taking place 16 June to 18 June. The online survey interviewed 120 virally suppressed PLWH in Taiwan and compared their self-reported HRQOL with that of the general population. The study, conducted between July to October 2021, measured HRQOL according to the EQ-5D-5L questionnaire, developed by EuroQOL, an international group of multidisciplinary researchers. The EQ-5D-5L is a standardized model that describes quality of life according to five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Respondents in the survey (n=120) generally reported high levels (median 80%) of self-perceived HRQOL. Detailed evaluation revealed discrepancies across different dimensions – higher level of HRQOL were reported in mobility, self-care and usual activities (such as carrying out duties at work, doing household chores and participating in leisure activities) while HRQOL were less optimal in the areas of pain/discomfort as well as anxiety/depression. Investigators believed that while some of these symptoms may be attributed to COVID-19, given the impact on mental wellness of the general population also reported during the pandemic, societal factors such as stigmatization in PLWH can affect mental well-being as more than two-thirds of respondents said they do not feel supported by society.

Final Data from Phase 3 Ascent Study Demonstrates Trodelvy Extends Overall Survival over Chemotherapy in Second-Line Metastatic TNBC

2022-06-06 13:00:00

Gilead Sciences, Inc. presented final data from the Phase 3 ASCENT study of Trodelvy® (sacituzumab govitecan-hziy) in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In a follow-up analysis from the final database lock, Trodelvy improved median progression-free survival versus physicians’ choice of chemotherapy (4.8 vs. 1.7 months; HR: 0.41; p<0.0001) and extended median overall survival (OS) by almost five months (11.8 vs. 6.9 months; HR: 0.51; p<0.0001) in the intent-to-treat population. The two-year OS rate was 20.5% (95% CI: 15.4-26.1) in the Trodelvy arm, compared with 5.5% (95% CI: 2.8-9.4) with physicians’ choice of chemotherapy. Trodelvy also showed clinically meaningful improvements in health-related quality of life (HRQoL) compared to chemotherapy. The results, which were consistent with the final analysis previously published in The New England Journal of Medicine, were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #1071). Trodelvy demonstrated higher clinically meaningful improvements in all five primary HRQoL domains compared to chemotherapy, which was consistent with previous reports. Metastatic TNBC is often associated with a significant decrease in quality of life, where patients may undergo many rounds of intensive chemotherapy, and assessing impact of symptom burden is especially important in this setting. Changes from baseline for Trodelvy vs. chemotherapy were -5.8 vs. -9.4 in global health status, -4.6 vs. -13.5 in physical functioning, -8.4 vs. -18.8 in role functioning, 5.1 vs. 14.0 in fatigue, and 2.8 vs. 6.8 in pain. The safety profile of Trodelvy was consistent with prior reports. Key Grade =3 treatment-related adverse reactions for Trodelvy compared to chemotherapy were diarrhea (11% vs. <1%), neutropenia (52% vs. 33%), anemia (8% vs. 5%), and febrile neutropenia (6% vs. 2%). Treatment discontinuations due to adverse events were =3% in both arms. The Trodelvy U.S. Prescribing Information has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information. TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all cases. It is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone hormone receptors and have limited or no HER2 expression. Because of this, treatment options are extremely limited compared with other breast cancer types. TNBC also has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer. Trodelvy® (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment. Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Trodelvy is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

Gilead Sciences, Inc. Announces Positive Results from the Primary Analysis of the Phase 3 TROPiCS-02 Study of Trodelvy®

2022-06-04 12:00:00

Gilead Sciences, Inc. announced positive results from the primary analysis of the Phase 3 TROPiCS-02 study of Trodelvy® (sacituzumab govitecan-hziy) versus physicians’ choice of chemotherapy (TPC) in heavily pre-treated HR+/HER2- metastatic breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint of progression-free survival (PFS) with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months; HR: 0.66; 95% CI: 0.53-0.83; P<0.0003). The first interim analysis of the key secondary endpoint of overall survival (OS) demonstrated a trend in improvement. These data are immature, and patients will be followed for subsequent OS analysis. These findings will be featured in both a press briefing and an oral session (Abstract #LBA1001) on June 4, 2022, during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The study demonstrated that at the one-year mark, three times as many patients were progression-free when treated with Trodelvy compared to those who received TPC (21% versus 7%). Improvements in PFS with Trodelvy were also consistent across key patient subgroups, including patients who had previously received three or more chemotherapy regimens for metastatic disease (HR: 0.70; CI: 0.52-0.95), patients with visceral metastasis (HR: 0.66; CI: 0.53-0.83), and the elderly (=65 years of age; HR: 0.59; CI: 0.38-0.93). A prespecified quality of life (QoL) analysis, one of the secondary endpoints using the EORTC QLQ-C30 instrument, also favored Trodelvy over TPC demonstrating meaningful benefit. In the evaluable population, improvements in global health status and fatigue with Trodelvy (n=234) compared with those who received TPC (n=207) were also observed. The safety profile for Trodelvy was consistent with prior studies, with no new safety concerns identified in this patient population. The most frequent Grade =3 treatment-related adverse reactions for Trodelvy compared to TPC were neutropenia (51% versus 38%), diarrhea (9% versus 1%), leukopenia (9% versus 5%), anemia (6% versus 3%), fatigue (6% versus 2%) and febrile neutropenia (5% versus 4%). Trodelvy has not been approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer. Its safety and efficacy have not been established for this indication. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer is the most common type of breast cancer and accounts for approximately 70% of all new cases, or nearly 400,000 diagnoses worldwide each year. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%. As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. In this setting, it is common to receive multiple lines of chemotherapy regimens over the course of treatment, and the prognosis remains poor. The TROPiCS-02 study is a global, multicenter, open-label, Phase 3 study, randomized 1:1 to evaluate Trodelvy versus physicians’ choice of chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) in 543 patients with HR+/HER2- metastatic breast cancer who were previously treated with endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy for metastatic disease. The primary endpoint is progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) for participants treated with Trodelvy compared to those treated with chemotherapy. Secondary endpoints include overall survival, overall response rate, clinical benefit rate and duration of response, as well as assessment of safety and tolerability and quality of life measures. In the study, HER2 negativity was defined per American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) criteria as immunohistochemistry (IHC) score of 0, IHC 1+ or IHC 2+ with a negative in-situ hybridization (ISH) test. Trodelvy® (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment. Trodelvy is approved in more than 35 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Trodelvy is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumor types where Trop-2 is highly expressed, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer. In the United States, Trodelvy is indicated for the treatment of: Adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. Adult patients with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

HOOKIPA Pharma Inc. Announces Preclinical Data, in Collaboration with Gilead Sciences, Inc

2022-06-03 11:00:00

HOOKIPA Pharma Inc. announced preclinical data, in collaboration with Gilead Sciences, Inc., on arenaviral therapeutic vaccines that are being studied as a component of a potential functional curative regimen for human immunodeficiency virus (HIV). These data presented at the Keystone Symposium: Progress in Vaccine Development for Infectious Disease in Breckenridge, Colorado highlight robust and high-quality immune responses following administration of replicating arenaviral therapeutic vaccines. Together, the preclinical data on the HIV arenaviral program support clinical development as a component of a potential HIV therapeutic. The analyses were conducted with a simian immunodeficiency virus (SIV) model, commonly used in a preclinical setting as an analog to HIV. Data presented in an oral presentation (poster 2019) explored systemic immune response in the blood to help determine the ideal arenaviral technology (replicating or non-replicating), route of administration and dosing frequency. The study showed both single-vector and alternating 2-vector therapy induced robust antigen-specific T cell and antibody responses in nonhuman primates. The 2-vector approach elicited a significantly greater T cell response than single-vector therapy, and intramuscular administration showed a modest benefit over intravenous administration in both the magnitude of T cell response and the consistency and durability of antibody response. Preclinical data in a separate poster presentation (poster 1019) showed the breadth and quality of the immune response with intramuscular administration of arenaviral therapeutic vaccines. Specifically, alternating 2-vector therapy generated robust antigen-specific immune responses throughout the body – in peripheral blood mononuclear cells (PBMCs), rectal mucosa and lymph nodes, all of which are important sites for HIV replication and/or transmission. The overall response was greater with the 2-vector approach compared to the single-vector approach.

Gilead Sciences, Inc. Announces Executive Changes

2022-06-02 13:00:00

Gilead Sciences, Inc. announced that Stacey Ma, PhD will join the company as Executive Vice President, Pharmaceutical Development and Manufacturing, and will become a member of the company’s senior leadership team, reporting to Chairman and Chief Executive Officer Daniel O’Day. Dr. Ma will assume responsibility for Gilead’s Pharmaceutical Development and Manufacturing organization effective July 18, 2022. Dr. Ma will succeed Dr. Yang, who is retiring from Gilead after nearly three decades. Dr. Ma brings to her new role more than 25 years of experience in process, pharmaceutical and analytical development, quality, technical product and supply chain management, as well as global manufacturing operations. She joins Gilead from Sana Biotechnology, where she most recently served as Executive Vice President and Head of Technical Operations. Prior to Sana, Dr. Ma was the Global Head of Innovation, Manufacturing Science and Technology in Genentech/Roche’s Pharma Technical Operations. Dr. Ma holds a PhD in chemical engineering from Yale University. She is an American Institute for Medical and Biological Engineering (AIMBE) fellow and has co-chaired many international scientific conferences and workshops related to Chemical, Manufacturing and Controls (CMC) development strategies, including several co-sponsored by the U.S. Food and Drug Administration, European Medicines Agency and China’s National Medical Products Administration. Dr. Yang joined Gilead in 1993 and became Senior Vice President of Pharmaceutical Development and Manufacturing in 2005. In 2015, she was appointed to her current role as Executive Vice President, Pharmaceutical Development and Manufacturing, with responsibility for all the company’s investigational compounds and marketed products. Under her leadership, Gilead developed the world’s first HIV single tablet regimen and advanced more than 25 compounds from early-stage development to market, reaching millions of people around the world.

Gilead Sciences, Inc. Presents at DIA Global Annual Meeting 2022, Jun-19-2022

2022-05-28 18:13:00

Gilead Sciences, Inc. Presents at DIA Global Annual Meeting 2022, Jun-19-2022 . Venue: Chicago, Illinois, United States. Speakers: Terrell Baptiste, Associate Director, Regulatory Policy and Intelligence.

Gilead Sciences, Inc. Presents at Tumor Myeloid Microenvironment Directed Therapeutics, Jun-14-2022 through Jun-16-2022

2022-05-24 13:17:00

Gilead Sciences, Inc. Presents at Tumor Myeloid Microenvironment Directed Therapeutics, Jun-14-2022 through Jun-16-2022. Venue: Boston, Massachusetts, United States. Presentation Date & Speakers: Jun-15-2022, Michelle Kuhne, Director. Jun-16-2022, Giri Ramsingh, Senior Medical Director.

Exavir Therapeutics announced that it has received $4 million in funding from Gilead Sciences, Inc., AlleyCorp

2022-05-23 00:00:00

Exavir Therapeutics announced that it has received $4,000,000 in its seed round of funding led by new investor AlleyCorp on May 23, 2022. The transaction included participation from new investor Gilead Sciences, Inc.

U.S. Food and Drug Administration Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV

2022-05-16 20:10:00

Gilead Sciences, Inc. announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). As previously announced, the FDA had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue. FDA removed the clinical hold following the agency’s review of Gilead’s comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass. Following today’s decision from the FDA, all activity can resume in the clinical studies evaluating injectable lenacapavir for HIV treatment and HIV PrEP. During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir were not permitted across all lenacapavir studies. Other study activities, including the monitoring of participants, the dosing of participants in comparator arms, and the dosing of oral formulations of lenacapavir continued according to the relevant study protocol. Gilead will now work with study site investigators to fully resume the lenacapavir clinical development programs as quickly as possible. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. Lenacapavir recently received a complete response letter (CRL) for its new drug application (NDA) in this population due to vial compatibility. Gilead is working with the FDA to discuss next steps for the potential use of lenacapavir for the treatment of HIV in this population. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.

Gilead Sciences, Inc. Presents at BIO International Convention 2022, Jun-13-2022

2022-05-15 00:00:00

Gilead Sciences, Inc. Presents at BIO International Convention 2022, Jun-13-2022 . Venue: San Diego Convention Center, San Diego, California, United States. Speakers: Sid Roychoudhury, Program Strategy Leader.

Gilead Sciences, Inc. Presents at Medicaid & Government Pricing Congress, May-24-2022 11:40 AM

2022-05-13 19:42:00

Gilead Sciences, Inc. Presents at Medicaid & Government Pricing Congress, May-24-2022 11:40 AM. Venue: Phildelphia, Pennsylvania, United States. Speakers: Cathy Burton-Meza, Associate Director, Government Rebates.

Gilead Sciences, Inc. Presents at Annual Treg Directed Therapies Summit, May-17-2022

2022-05-10 14:42:00

Gilead Sciences, Inc. Presents at Annual Treg Directed Therapies Summit, May-17-2022 . Venue: Boston, Massachusetts, United States. Speakers: Anubhav Mathur, Director, Clinical Research.

Gilead Sciences, Inc. Presents at CLOC Global Institute, May-09-2022

2022-05-08 09:48:00

Gilead Sciences, Inc. Presents at CLOC Global Institute, May-09-2022 . Venue: Las Vegas, Nevada, United States. Speakers: Kevin Wong.

Declaration of Voting Results by Gilead Sciences, Inc

2022-05-05 16:02:00

On May 5, 2022, Gilead Sciences, Inc. announced that at its annual general meeting of shareholder held on May 4, 2022, the Company’s stockholders did not approve a stockholder proposal requesting that the Board publish a third-party review of the Company’s lobbying activities.

Declaration of Voting Results by Gilead Sciences, Inc

2022-05-05 16:02:00

On May 5, 2022, Gilead Sciences, Inc. announced that at its annual general meeting of shareholder held on May 4, 2022, The Company’s stockholders did not approve a stockholder proposal requesting that the board of directors of the Company adopt a policy that the Chairperson of the Board be an independent director.

Declaration of Voting Results by Gilead Sciences, Inc

2022-05-05 16:02:00

On May 5, 2022, Gilead Sciences, Inc. announced that at its annual general meeting of shareholder held on May 4, 2022, The Company’s stockholders did not approve a stockholder proposal requesting that the Board include one member from the Company’s non-management employees.

Declaration of Voting Results by Gilead Sciences, Inc

2022-05-05 16:02:00

On May 5, 2022, Gilead Sciences, Inc. announced that at its annual general meeting of shareholder held on May 4, 2022, the Company’s stockholders approved a stockholder proposal requesting a 10% threshold to call a special stockholder meeting.

Declaration of Voting Results by Gilead Sciences, Inc

2022-05-05 16:02:00

On May 5, 2022, Gilead Sciences, Inc. announced that at its annual general meeting of shareholder held on May 4, 2022, the Company’s stockholders did not approve a stockholder proposal requesting that the Board publish a third-party review of the Company’s lobbying activities.

Declaration of Voting Results by Gilead Sciences, Inc

2022-05-05 16:02:00

On May 5, 2022, Gilead Sciences, Inc. announced that at its annual general meeting of shareholder held on May 4, 2022, the Company’s stockholders did not approve a stockholder proposal requesting a Board report on oversight of risks related to anticompetitive practices.

Curebase, Inc. announced that it has received $40.000011 million in funding from a group of investors

2022-05-05 00:00:00

On May 5, 2022, Curebase, Inc. closed the transaction. The round of funding led by new investor Industry Ventures, L.L.C. The transaction included participation from new investors, aCrew Capital, Wil LLC, Positive Sum Advisors, Gilead Sciences, Inc., and Gaingels, LLC, existing investors GGV Capital, LLC, Bold Capital Partners, and Xfund Management Company, LLC.

Gilead Sciences, Inc. has filed a Shelf Registration in the amount of $8.19456 billion.

2022-05-05 00:00:00

Gilead Sciences, Inc. has filed a Shelf Registration in the amount of $8.19456 billion. Security Name: Common Stock Securities Offered: 132,000,000 Transaction Features: ESOP Related Offering

Tranche Update on Gilead Sciences, Inc. (NasdaqGS:GILD)'s Equity Buyback Plan announced on February 2, 2016.

2022-05-04 16:26:00

From January 1, 2022 to March 31, 2022, the company has repurchased 5,526,000 shares, representing 0.44% for $350.94 million. With this, the company has completed the repurchase of 151,183,000 shares, representing 11.68% for $11,076.11 million under the buyback announced on February 2, 2016.

Tranche Update on Gilead Sciences, Inc. (NasdaqGS:GILD)'s Equity Buyback Plan announced on February 25, 2020.

2022-05-04 16:26:00

From January 1, 2022 to March 31, 2022, the company has repurchased 0 shares, representing 0% for $0 million. With this, the company has completed the repurchase of 0 shares, representing 0% for $0 million under the buyback announced on February 25, 2020.

Gilead Sciences, Inc. and Dragonfly Announce Strategic Research Collaboration to Develop Natural Killer Cell Engagers in Oncology and Inflammation

2022-05-02 12:30:00

Gilead Sciences, Inc. and Dragonfly Therapeutics announced collaboration designed to advance a number of Dragonfly's novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications. NK cell engagers represent a novel mechanism with the potential to address a broad range of cancers, including potential for activity in checkpoint resistant and refractory tumors, as well as other disease areas such as inflammation. Under the agreement, Gilead will receive an exclusive, worldwide license from Dragonfly for the 5T4-targeting investigational immunotherapy program, DF7001. The agreement also grants Gilead options, after the completion of certain preclinical activities, to license exclusive, worldwide rights to develop and commercialize additional NK cell engager programs using the Dragonfly Tri-specific NK Engager (TriNKET™) platform. TriNKETs are activators of the innate and adaptive immune systems, recruiting NK and cytotoxic T cells into the tumor microenvironment. DF7001 is a TriNKET designed to activate and direct NK and cytotoxic T cell killing against cancer cells. The target of DF7001 is 5T4, a protein expressed on cancer cells and stromal cells that support tumor growth associated with poor prognosis in several cancers, including non-small cell lung cancer (NSCLC), pancreatic cancer, breast cancer, and head and neck squamous cell carcinomas (HNSCC). DF7001 has the potential to trigger the killing of 5T4+ expressing cells, including tumor cells, cancer-associated fibroblasts and cancer stem cells. The program is on track for filing an Investigational New Drug (IND) application in the first half of 2023. Terms of the Agreement: Under the terms of the agreement, Gilead will make a $300 million upfront payment to Dragonfly. In addition, Dragonfly is eligible to receive potential opt-in payments and performance-based development, regulatory and commercial milestone payments. Dragonfly will also be eligible to receive royalties of up to 20% on worldwide net sales. The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. DF7001 is an investigational product candidate; it is not approved by any regulatory agency for any use and has not been proven safe or efficacious.

Gilead Sciences Seeks Acquisitions

2022-04-28 20:30:00

Gilead Sciences, Inc. (NasdaqGS:GILD) is looking for acquisitions. Chief Financial Officer, Andrew Dickinson, said "on M&A, there is no change to our philosophy here either. We are very comfortable with the breadth and the quality of the pipeline that we have built, acquired or partnered, and the growth that it will enable in the coming years. With that in mind, you can expect us to continue to opportunistically access high-quality assets through partnerships or make smaller acquisitions in the normal course of business".

Gilead Sciences, Inc. Declares Quarterly Cash Dividend for the Second Quarter of 2022, Payable on June 29, 2022

2022-04-28 20:02:00

Board of Directors of Gilead Sciences, Inc. declared a quarterly dividend of $0.73 per share of common stock for the second quarter of 2022. The dividend is payable on June 29, 2022, to stockholders of record at the close of business on June 15, 2022.

Gilead Sciences, Inc. Revises Earnings Guidance for the Fiscal Year 2022

2022-04-28 20:02:00

Gilead Sciences, Inc. revised earnings guidance for the fiscal year 2022. For the period, the company expects total product sales to be between $23.8 billion and $24.3 billion. EPS to be between $3.00 and $3.50, compared to $4.70 and $5.20 previously.

Gilead Sciences, Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 11:00 AM

2022-04-27 01:29:00

Gilead Sciences, Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 11:00 AM. Venue: Marriott Marquis, New York City, New York, United States.

Gilead Sciences, Inc. Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-15-2022 11:20 AM

2022-04-27 01:29:00

Gilead Sciences, Inc. Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-15-2022 11:20 AM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

Gilead Sciences, Inc., $ 0.73, Cash Dividend, Jun-14-2022

2022-04-27 00:00:00

Gilead Sciences, Inc., $ 0.73, Cash Dividend, Jun-14-2022

Gilead Sciences Announces Veklury® (Remdesivir) is First and Only Approved Treatment for Pediatric Patients Under 12 Years of Age with COVID-19

2022-04-25 18:29:00

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury® (remdesivir) for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to severe COVID-19, including hospitalization or death. This approval follows the recent sNDA approval for Vekluryfor the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19. Under the expanded indication, a three-day Veklury treatment regimen is recommended to help prevent hospitalization in non-hospitalized COVID-19 pediatric patients who are at high risk for COVID-19 disease progression. For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a 5-day treatment course is recommended. Veklury is contraindicated in patients who are allergic to Veklury or any of its components.

Gilead Sciences, Inc. Announces Findings from Two Studies, Which Provide Further Insights on the Use of Veklury® (Remdesivir) for the Treatment of Hospitalized and Non-Hospitalized Patients with COVID-19

2022-04-24 22:05:00

Gilead Sciences, Inc. announced findings from two studies, which provide further insights on the use of Veklury® (remdesivir) for the treatment of hospitalized and non-hospitalized patients with COVID-19. The first study is a retrospective observational analysis of the real-world treatment data from the Premier Healthcare Database consisting of 853,219 patients hospitalized with COVID-19 across the United States. This analysis found that more than 50% of hospitalized COVID-19 patients received Veklury, predominantly in combination with other therapies. An oral presentation of this real-world data analysis will be given on April 25 at 11 a.m. Western European Summer Time in Hall P at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022). A separate study, which is a new post-hoc analysis of data from the Phase 3 PINETREE study, demonstrated that use of Veklury within five days of symptom onset or between 5 to 7 days of symptom onset reduced hospitalizations in patients at high risk for severe COVID-19 disease. This post-hoc analysis was presented as a poster (#L0447) at ECCMID. The observational analysis of real-world data also found that as the pandemic progressed, initiation of Veklury within two days of hospitalization increased from 41% to 91% between May 2020 and December 2021. During this period, as new variants arose and disease severity fluctuated, median hospital length of stay (LOS) decreased from seven to six days with the greatest benefit in invasive mechanical ventilation/ECMO patients (15 to 11 days). While ICU use decreased from 34% to 27%, with the greatest benefit in high-flow oxygen/non-invasive ventilation (66% to 52%), overall ICU LOS remained the same. Overall mortality rates remained stable at 16%, with the greatest decline over time in patients on low-flow supplemental oxygen (15% to 12%). These results confirm Veklury’s position as a foundational treatment for hospitalized patients with COVID-19 and signify the need to treat patients early before they become more severely ill with COVID-19. The new post-hoc analysis from a Phase 3 double-blind, placebo-controlled trial (PINETREE) demonstrating that a three-day course of Veklury treatment significantly reduced the risk of hospitalization was also presented at ECCMID. The analysis assessed the variability of treatment effect with Veklury by time of symptom onset and number of baseline risk factors. The study concluded that Veklury reduced hospitalizations in patients at high risk for severe COVID-19 disease when initiated anytime within a 7-day window from symptom onset. As expected with antiviral therapy, the benefit was modestly greater the sooner Veklury was administered. Patients treated with Veklury within five days of symptom onset had a 90% reduced risk for hospitalization. Additionally, patients who received Veklury after five 5 days of symptom onset experienced an 81% reduction in risk of hospitalization. This new analysis builds on the previously presented primary endpoint analysis, in which Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008); no deaths occurred in either arm of the study through the primary endpoint. Gilead presented two additional studies from the company’s COVID-19 clinical and real-world evidence programs at the conference. Data from the CARAVAN study evaluated safety, pharmacokinetic, virologic, and clinical outcomes of Veklury treatment in pediatric patients who were 28 days of age and older. The interim analysis of Veklury in pediatric patients hospitalized with COVID-19 with ages ranging from 28 days to less than 18 years demonstrated that Veklury was generally well tolerated, with a high proportion of participants showing clinical improvement and recovery. Overall, no new safety findings for Veklury were noted. In the study, 75% and 85% showed clinical improvement (=2 point increase on the ordinal scale) at Day 10 and last assessment, respectively, while 60% and 83% were discharged by Day 10 and Day 30, respectively. Overall, 38 patients (72%) experienced AEs, with 11 patients (21%) experiencing serious adverse events (SAEs) that were determined not to be study-drug related, including 3 participant deaths which were consistent with the patients’ underlying medical condition prior to study entry or with COVID-19 disease during hospitalization. A real-world evidence analysis evaluated data from 2,310 patients hospitalized with COVID-19 who had previously undergone kidney transplantation. The analysis found that in this patient population, overall mortality was comparable to the general population hospitalized with COVID-19, but markedly increased for those with diminished renal function, comorbidities, and higher oxygen requirements upon admission. Insights from this study help inform clinical decision-making in the context of management of kidney transplant patients and other solid-organ transplant recipients, alike.

Gilead Sciences, Inc. Presents at Bernstein 38th Annual Strategic Decisions Conference, Jun-02-2022 04:30 PM

2022-04-22 20:35:00

Gilead Sciences, Inc. Presents at Bernstein 38th Annual Strategic Decisions Conference, Jun-02-2022 04:30 PM. Venue: New York Hilton Midtown, 1335 Avenue of the Americas, New York City, New York, United States. Speakers: Andrew D. Dickinson, Executive VP & CFO.

Informa plc, Medicaid & Government Pricing Congress, May 23, 2022 through Jun 02, 2022

2022-04-18 14:20:00

Informa plc, Medicaid & Government Pricing Congress, May 23, 2022 through Jun 02, 2022. Venue: Phildelphia, Pennsylvania, United States.

Gilead Sciences, Inc. to Report Q1, 2022 Results on Apr 28, 2022

2022-04-14 20:05:00

Gilead Sciences, Inc. announced that they will report Q1, 2022 results After-Market on Apr 28, 2022

Gilead Sciences, Inc., Q1 2022 Earnings Call, Apr 28, 2022

2022-04-14 20:05:00

Gilead Sciences, Inc., Q1 2022 Earnings Call, Apr 28, 2022

GlaxoSmithKline plc (LSE:GSK) entered into an agreement to acquire Sierra Oncology, Inc. (NasdaqGM:SRRA) for $1.3 billion.

2022-04-13 00:00:00

GlaxoSmithKline plc (LSE:GSK) entered into an agreement to acquire Sierra Oncology, Inc. (NasdaqGM:SRRA) from Frazier Healthcare VI, L.P., Frazier Life Sciences VIII, L.P., Frazier Life Sciences Public Fund, L.P., all managed by Frazier Management, L.L.C., and others for $1.3 billion on April 12, 2022. Under the terms of the agreement, the acquisition will be effected through a one-step merger in which the shares of Sierra Oncology outstanding will be cancelled and converted into the right to receive $55 per share in cash. Under the terms of the agreement, the acquisition will be effected through a one-step merger in which the shares of Sierra Oncology outstanding will be cancelled and converted into the right to receive $55 per share in cash. Furthermore, each of the Sierra Oncology’s stock options will receive an amount in cash equal to the excess of offer per share over the exercise price and Series A warrants will receive $45.98 per warrant. All pre-funded warrants will be deemed exercised in full as a “cashless exercise” and would receive $55 per warrant. Sierra Oncology shall pay a termination fee of $70 million to GlaxoSmithKline. The transaction is subject to customary conditions, including the approval of the merger by at least a majority of the issued and outstanding shares of Sierra Oncology and the expiration or earlier termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The transaction was unanimously approved by the Board of Directors of Sierra Oncology. The initial waiting period under the HSR Act is set to expire on May 31, 2022. On May 31, 2022, the waiting period under the HSR Act expired with respect to the Merger. The shareholders meeting of Sierra Oncology is scheduled on June 29, 2022. The transaction is expected to close in the third quarter of 2022 or before. GSK will account for the transaction as a business combination and expects it to be accretive to adjusted EPS in 2024, the expected first full year of momelotinib’s sales. PJT Partners is acting as financial advisor and Benet O’Reilly and Kimberly Spoerri of Cleary Gottlieb Steen & Hamilton LLP is serving as legal counsel to GSK in connection with the transaction. Lazard Freres & Co. LLC is acting as financial advisor and fairness opinion provider while Robert Ishii, Remi Korenblit and Michael Nordtvedt of Wilson Sonsini Goodrich & Rosati, is serving as legal counsel to Sierra Oncology. Graham Robinson and Marie L Gibson of Skadden represented Lazard Freres & Co. LLC in the transaction. Innisfree M&A Inc. acted as proxy solicitor and American Stock Transfer & Trust Company, LLC acted as transfer agent to Sierra Oncology. Sierra Oncology has agreed to pay a fee of $25,000 to Innisfree for its services. Sierra Oncology will pay Lazard, a transaction fee of approximately $44 million, payable upon the consummation of the merger, of which $2 million became payable upon delivery of the fairness opinion.

U.S. Food and Drug Administration Lifts Partial Clinical Hold on Gilead Sciences, Inc.'s MDS and AML Magrolimab Studies

2022-04-11 20:07:00

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. The FDA removed the partial clinical hold after a review of the comprehensive safety data from each trial.With today’s decision from the FDA, enrollment in the U.S. can resume for the studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Gilead, in close coordination with regulatory authorities, is planning to re-open enrollment in the magrolimab studies that were placed on a voluntary hold outside of the U.S. The company is also working with the FDA regarding the remaining partial clinical hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma. The ongoing clinical studies evaluating magrolimab in solid tumors were not subject to the clinical hold. During the partial clinical hold, patients already enrolled in the affected Gilead magrolimab studies, including the pivotal, Phase 3 ENHANCE study, continued receiving treatment. Prior to the trial hold, Gilead already met the pre-specified enrollment threshold required for the first interim analysis of the ENHANCE study. Based on this, Gilead is confident the readout for the first interim analysis remains on schedule for 2023. Magrolimab was granted Breakthrough Therapy designation for the treatment of newly diagnosed MDS by the FDA in 2020. In addition to MDS and AML, magrolimab is being developed in several hematologic cancers and solid tumor malignancies. Magrolimab is an investigational product and is not approved by any regulatory authority for any use; its safety and efficacy have not been established. MDS is a rare, often unrecognized, under-diagnosed, bone marrow disorder widely considered to be a form of cancer. In MDS, the body’s bone marrow does not make enough mature, healthy red blood cells, white blood cells and/or platelets. While many cases may go undiagnosed, current estimates show that ~100,000 new cases are diagnosed each year. Therapeutic advancement for higher-risk MDS has been limited in the last 15 years and stem cell transplant is the only potential cure, but those older than 65 or with other conditions are often not eligible. One in three people with MDS will progress to AML, one of the most common types of leukemia in adults. Approximately 10,000 people die every year from AML in the U.S.

United Church Funds Files an Exempt Solicitation Statement to Shareholders of Gilead Sciences Inc

2022-04-11 06:02:00

On April 11, 2022, United Church Funds has filed an exempt solicitation statement and urged the shareholders of Gilead Sciences Inc to vote for its proposal related to adopt a policy that the chairperson of the board of directors be an independent director, at the annual meeting of shareholders scheduled to be held on May 4, 2022.

The Maryknoll Sisters of St. Dominic, Inc Urges Shareholders of Gilead Sciences Inc to Support Its Shareholders Proposal

2022-04-07 10:06:00

On April 7, 2022, The Maryknoll Sisters of St. Dominic, Inc requested the shareholders of Gilead Sciences Inc to vote for its shareholder proposal to undertake and publish a third-party review on the Company’s lobbying activities, at the annual meeting of shareholders to be held on May 4, 2022.

Shareholder Association for Research & Education Files an Exempt Solicitation Statement to Shareholders of Gilead Sciences Inc

2022-04-07 10:06:00

On April 7, 2022, Shareholder Association for Research & Education filed an exempt solicitation statement and urged the shareholders of Gilead Sciences Inc to vote for its shareholder proposal to undertake and publish a third-party review on the Company’s lobbying activities, at the annual meeting of shareholders to be held on May 4, 2022.

Mercy Investment Services Inc Files an Exempt Solicitation Statement to Shareholders of Gilead Sciences Inc

2022-04-05 16:53:00

On April 5, 2022, Mercy Investment Services Inc has filed an exempt solicitation statement and urged the shareholders of Gilead Sciences Inc to vote for its proposal related to oversight of risks related to anticompetitive practices, at the 2022 annual meeting of shareholders.

The National Action Network, National Action Network's 2022 Convention, Apr 06, 2022 through Apr 09, 2022

2022-04-04 18:28:00

The National Action Network, National Action Network's 2022 Convention, Apr 06, 2022 through Apr 09, 2022. Venue: Sheraton New York Times Square Hotel, 811 7th Avenue, New York, New York, United States. The purpose of the event is to bring together some of the country's most influential figures – from topgovernment officials, to faith and civil rights leaders to grassroots organizations. In its 31st year, theevent will address our nation's crisis in racial justice and meaningful forms of action.

Gilead Sciences, Inc. Presents at National Action Network's 2022 Convention, Apr-08-2022 04:45 PM

2022-04-04 18:28:00

Gilead Sciences, Inc. Presents at National Action Network's 2022 Convention, Apr-08-2022 04:45 PM. Venue: Sheraton New York Times Square Hotel, 811 7th Avenue, New York, New York, United States. Speakers: Deborah Wafer, HIV Prevention Medical Scientist.

Kite, a Gilead Company Announces Yescarta Receives U.S. Food and Drug Administration Approval as First CAR T-Cell Therapy for Initial Treatment of Relapsed or Refractory Large B-Cell Lymphoma

2022-04-01 22:01:00

Kite, a Gilead Company announced the U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001) over the current standard of care (SOC) that has been in place for decades. EFS was determined by blinded central review and defined as the time from randomization to the earliest date of disease progression, commencement of new lymphoma therapy, or death from any cause. Additionally, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without disease progression or need for additional cancer treatment, after their one-time infusion of Yescarta vs. SOC (16.3%), and the median EFS was four-fold greater (8.3 months vs. 2.0 months) with Yescarta vs. SOC. Yescarta is also being reviewed by global regulatory authorities for additional indications inclusive of the ZUMA-7 patient population. Earlier this month, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for B-cell Lymphomas to include Yescarta for “Relapsed disease <12 mo or Primary Refractory disease” under Diffuse Large B-cell Lymphoma (DLBCL) as a Category 1 recommendation. Yescarta is the first CAR T-cell therapy to receive a NCCN Category 1 recommendation. NCCN defines Category 1 as recommendations based upon high-level evidence with uniform NCCN consensus that the intervention is appropriate. CAR T-cell therapies are individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite’s specialized manufacturing facilities where they are engineered to target the patient’s cancer, expanded, and then returned to the hospital for infusion back into the patient. Referring physicians and patients can immediately begin accessing Yescarta CAR T-cell therapy for this new FDA-approved indication through Kite’s 112 authorized treatment centers across the U.S. SOC therapy for this patient population has historically been a multi-step process expected to end with a stem cell transplant. The process starts with chemoimmunotherapy, and if a patient responds to and can tolerate further treatment, they move on to high-dose chemotherapy (HDT) followed by a stem cell transplant (ASCT). Kite CAR T-cell therapy products are widely covered by commercial and government insurance programs in the U.S. Kite has also invested in expansion of manufacturing capacity ahead of FDA decision to support patient access. Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy. The ZUMA-1 trial has recently reported durable 5-year survival results, with Yescarta showing 42.6% of study patients alive at 5 years and that 92% of those patients alive at 5 years have needed no additional cancer treatment at this important milestone. As the only company dedicated exclusively to the research, development, commercialization, and manufacturing of cell therapy on a global scale, Kite has all functions critical to cell therapy vertically integrated. This structure enables the continual refinement and support of the highly specialized and complex end-to-end processes needed to support and improve upon patient outcomes with CAR T-cell therapy.

Hanson Wade Limited, Annual Treg Directed Therapies Summit, May 17, 2022 through May 19, 2022

2022-03-31 14:24:00

Hanson Wade Limited, Annual Treg Directed Therapies Summit, May 17, 2022 through May 19, 2022. Venue: Boston, Massachusetts, United States.

Gilead Sciences, Inc. Presents at 12th Annual World ADC Conference 2022, Mar-31-2022 04:00 PM

2022-03-30 09:20:00

Gilead Sciences, Inc. Presents at 12th Annual World ADC Conference 2022, Mar-31-2022 04:00 PM. Venue: London, United Kingdom. Speakers: Daejin Abidoye, SVP Oncology Therapeutics.

Hanson Wade Limited, 12th Annual World ADC Conference 2022, Mar 29, 2022 through Mar 31, 2022

2022-03-29 17:52:00

Hanson Wade Limited, 12th Annual World ADC Conference 2022, Mar 29, 2022 through Mar 31, 2022. Venue: London, United Kingdom.

Gilead Sciences, Inc. Presents at Pharma Manufacturing World Summit, Mar-29-2022

2022-03-29 08:36:00

Gilead Sciences, Inc. Presents at Pharma Manufacturing World Summit, Mar-29-2022 . Venue: Boston Marriott Copley Place, Boston, Massachusetts, United States. Speakers: Ken Kent, SVP, Chemical Development and Manufacturing Operations.

Gilead Sciences, Inc., Annual General Meeting, May 04, 2022

2022-03-24 20:04:00

Gilead Sciences, Inc., Annual General Meeting, May 04, 2022, at 10:00 Pacific Daylight. Agenda: To elect the nine director nominees named in this Proxy Statement to serve for the next year and until their successors are elected and qualified; to ratify the selection of Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2022; to approve, on an advisory basis, the compensation of our named executive officers as presented in the Proxy Statement; to approve the Gilead Sciences, Inc. 2022 Equity Incentive Plan; to vote on a stockholder proposal, if properly presented at the meeting, requesting that the Board adopt a policy that the Chairperson of the Board of Directors be an independent director; to vote on a stockholder proposal, if properly presented at the meeting, requesting that the Board include one member from Gilead’s non-management employees; and to consider other matters.

Gilead Sciences, Inc. - Shareholder/Analyst Call

2022-03-24 20:04:00

Annual Meeting of Stockholders

Gilead Sciences, Inc. Presents at Bank of America 2022 Healthcare Conference, May-10-2022 02:00 PM

2022-03-22 05:03:00

Gilead Sciences, Inc. Presents at Bank of America 2022 Healthcare Conference, May-10-2022 02:00 PM. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States. Speakers: Andrew D. Dickinson, Executive VP & CFO.

Executive Platforms Inc., Pharma Manufacturing World Summit, Mar 29, 2022 through Mar 30, 2022

2022-03-21 14:57:00

Executive Platforms Inc., Pharma Manufacturing World Summit, Mar 29, 2022 through Mar 30, 2022. Venue: Boston Marriott Copley Place, Boston, Massachusetts, United States.

Sanford C. Bernstein & Co., LLC, Bernstein 38th Annual Strategic Decisions Conference, Jun 01, 2022 through Jun 03, 2022

2022-03-17 15:04:00

Sanford C. Bernstein & Co., LLC, Bernstein 38th Annual Strategic Decisions Conference, Jun 01, 2022 through Jun 03, 2022. Venue: New York Hilton Midtown, 1335 Avenue of the Americas, New York City, New York, United States.

Curebase, Inc. announced that it expects to receive $40.000011 million in funding

2022-03-15 00:00:00

Curebase, Inc. announced that it will issue 4,146,067 series B preferred stock at an issue price of $9.6477 per share for gross proceeds of $40,000,011 on March 15, 2022. The shares are convertible, participating, non-redeemable and non-cumulative. The shares will be convertible in common shares at a price of $9.6477 per share. The preferred shares are entitled to receive non-cumulative dividend at rate of 6% per annum

Hanson Wade Limited, Tumor Myeloid Microenvironment Directed Therapeutics, Jun 14, 2022 through Jun 16, 2022

2022-02-28 18:16:00

Hanson Wade Limited, Tumor Myeloid Microenvironment Directed Therapeutics, Jun 14, 2022 through Jun 16, 2022. Venue: Boston, Massachusetts, United States.

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022

2022-02-17 10:42:00

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States.

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022

2022-02-14 21:00:00

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022. Venue: Marriott Marquis, New York City, New York, United States.

Gilead Sciences, Inc. Announces Phase 2/3 Interim Data Evaluating the Safety, Tolerability and Clinical Outcomes of Veklury (Remdesivir) in Pediatric Patients With COVID-19 Presented at CROI 2022

2022-02-11 22:15:00

Gilead Sciences, Inc. announced new data from an interim analysis of its ongoing, Phase 2/3 single arm, open-label study to evaluate the safety, tolerability and pharmacokinetics of Veklury® (remdesivir) in pediatric patients hospitalized with COVID-19 with ages ranging from 28 days to less than 18 years. This data will be presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022) taking place from February 12-16. These latest data demonstrate that Veklury was generally well tolerated among pediatric patients hospitalized with COVID-19 with a high proportion of participants showing clinical improvement and recovery. Overall, no new safety findings for Veklury were noted, and 85% of patients showed clinical improvement based on the clinical ordinal scale and the recovery rate was 83% at last assessment (N=53). The primary objective of this study was to evaluate the safety, tolerability, and pharmacokinetics of Veklury in pediatric patients, as assessed by the proportion of participants experiencing treatment-emergent adverse events; proportion of participants experiencing treatment-emergent graded laboratory abnormalities; and plasma concentrations of Veklury and metabolites, respectively. Safety was assessed by adverse events (AEs) and lab tests (hematology, chemistry, urine, inflammatory, coagulation). Clinical outcomes included improvement on a 7-point ordinal scale, time to discharge, and oxygenation modality. Virologic outcomes included days to confirmed negative SARS-CoV-2 PCR (defined as 2 consecutive negative results). In this study of 53 pediatric patients across five cohorts grouped by age (median age 7 years) with more than half (57%) being on high-flow oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at baseline. Of the 53 pediatric patients enrolled in the study, no new safety signals were apparent for Veklury. Overall, 38 patients (72%) experienced AEs, with 11 patients (21%) experiencing serious adverse events (SAEs) that were determined not to be study-drug related, including 3 participant deaths which were consistent with the patients’ underlying medical conditions prior to study entry or with COVID-19 disease during hospitalization. Children weighing at least 40kg were in cohorts 1 and 8 and received 200mg on Day 1 followed by 100mg daily. Infants and children weighing 3kg to less than 40kg were in cohorts 2-4 and received weight-based dosing of 5mg/kg on Day 1 followed by 2.5mg/kg daily. In the analysis, the most common adverse event in patients taking Veklury was constipation (17%), followed by acute kidney injury (11%), hyperglycemia (9%) and pyrexia (9%). Additionally, 8% of participants had an increase in alanine transaminase (ALT). On January 21, 2022, the U.S. Food and Drug Administration (FDA) expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients weighing at least 3.5 kg who are younger than 12 years of age or weighing less than 40 kg who are at high risk of disease progression, in addition to those with COVID-19 requiring hospitalization. Gilead has submitted this interim data to the FDA, EMA and other regulatory agencies. The use of Veklury in pediatric patients younger than 12 years of age or weighing less than 40 kg is investigational and Veklury is not approved by the FDA for this use. Please see below for more information on the approved use of Veklury and the EUA for pediatric patients.

Gilead Sciences, Inc. Announces Veklury (Remdesivir) Retains Antiviral Activity Against Omicron, Delta and Other Emergent SARS-CoV-2 Variants in Multiple In Vitro Studies

2022-02-11 13:01:00

Gilead Sciences, Inc. released data demonstrating the in vitro activity of Veklury (remdesivir) against ten SARS-CoV-2 variants, including Omicron. Results of Gilead studies are consistent with other in vitro studies independently conducted by researchers from institutions in other countries, including Belgium, Czech Republic, Germany, Poland, and the United States, which confirmed Veklury’s antiviral activity against multiple previously identified variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta and Omicron. The study analyzed in vitro antiviral activity by two methods to understand the susceptibility of ten major SARS-CoV-2 variants to Veklury. The study results showed similar activity of Veklury against the variants and an early ancestral A lineage isolate detected in Seattle, WA (WA1 strain). Specifically, Delta and Omicron variants both remained fully susceptible to Veklury, and these laboratory results demonstrate that Veklury has remained active against all major variants isolated over the past two years. Veklury directly inhibits viral replication inside host cells by targeting the SARS-CoV-2 RNA-dependent RNA polymerase. On entering the body, Veklury is transformed into the active triphosphate metabolite, which is then incorporated into the viral RNA and stops replication of the virus within the infected cells. The study analyzed nearly 6 million publicly available variant isolate sequences and confirmed that the nsp12 protein, the RNA polymerase target of Veklury, is highly conserved across all variants. Further characterization confirmed that none of the few identified nsp12 mutations prevalent in some of the SARS-CoV-2 variants affects the virus susceptibility to Veklury.

The Goldman Sachs Group, Inc., Goldman Sachs 43rd Annual Global Healthcare Conference, Jun 13, 2022 through Jun 16, 2022

2022-02-08 07:31:00

The Goldman Sachs Group, Inc., Goldman Sachs 43rd Annual Global Healthcare Conference, Jun 13, 2022 through Jun 16, 2022. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

Gilead Sciences, Inc. Presents at SCOPE Summit 2022, Feb-10-2022 09:40 AM

2022-02-04 08:35:00

Gilead Sciences, Inc. Presents at SCOPE Summit 2022, Feb-10-2022 09:40 AM. Venue: Orlanda, Florida, United States. Speakers: Kevin J. O'Brien, Senior Director & Global Head, Clinical Contracts & Finance.

GlaxoSmithKline plc Announces Settlement between ViiV Healthcare and Gilead Sciences, Inc

2022-02-02 07:00:00

GlaxoSmithKline plc announced that ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited (Shionogi) as shareholders, has agreed to settle the global patent infringement litigation between GSK, Shionogi and Gilead Sciences, Inc. (Gilead) concerning ViiV Healthcare's patents relating to dolutegravir, an antiretroviral medication used, together with other medicines, to treat human immunodeficiency virus (HIV). ViiV Healthcare, GSK and Shionogi alleged that Gilead's Biktarvy, a triple combination HIV medicine containing the HIV integrase inhibitor bictegravir, tenofovir alafenamide and emtricitabine, infringed certain of their patents relating to dolutegravir. As a result of the settlement, patent infringement cases in the US, UK, France, Ireland, Germany, Japan, Korea, Australia, and Canada will be discontinued. ViiV Healthcare, GSK, Shionogi and Gilead have entered into a global settlement agreement and a patent license agreement under which Gilead has been granted a worldwide licence to certain ViiV Healthcare patents relating to dolutegravir and a covenant not to enforce any patents controlled by ViiV Healthcare, GSK or Shionogi against Gilead in connection with any past or future claims of infringement relating to Biktarvy. ViiV Healthcare, GSK and Shionogi have also agreed not to enforce their patents against any future product containing bictegravir, to the extent that the patent enforcement relates to the bictegravir component of the product. Under the terms of the global settlement and licensing agreement, Gilead will make an upfront payment of $1.25 billion to ViiV Healthcare which is expected in the first quarter of 2022. In addition, Gilead will also pay a 3% royalty on all future US sales of Biktarvy ($6.09 billion in 2020) and in respect of the bictegravir component of any other future bictegravir-containing products sold in the US. These royalties will be payable by Gilead to ViiV Healthcare from 1 February 2022 until the expiry of ViiV Healthcare's U.S. Patent No. 8,129,385 on 5 October 2027. Gilead's obligation to pay royalties does not extend into any period of regulatory paediatric exclusivity, if awarded. Regulatory paediatric exclusivity would extend the period of exclusivity after the expiry of the '385 patent by six months from 5 October 2027 to 5 April 2028. The upfront payment and royalty income will be distributed in proportion to the ordinary shareholding in ViiV Healthcare (GSK 78.3%, Pfizer 11.7%, Shionogi 10%) net of the contingent consideration liability (CCL) to Shionogi and applicable tax. The upfront payment of $1.25 billion will be recorded in GSK's financial results as an adjusting item in the income statement for the first quarter of 2022. The future royalty income will be recorded in total and adjusted results in the income statements for 2022 to 2027 inclusive. Both the settlement and the future royalty income increase the fair value of the CCL to Shionogi, and the Pfizer put option. These increases in fair value will be reflected in GSK's 2021 full-year and fourth-quarter results, and the associated charges will be recorded within adjusting items. Cash in-flows from the upfront payment and future royalty income and cash out-flows from the CCL will be recorded in cash generated from operations. The resulting increased dividends to Shionogi and Pfizer will be included within financing cashflows. Full details of the operational accounting of the CCL can be found on pages 52-53 of GSK's 2020 Annual Report.

Gilead Sciences, Inc. Declares Quarterly Cash Dividend for the First Quarter of 2022, Payable on March 30, 2022

2022-02-01 21:10:00

Gilead Sciences, Inc. announced that the company’s board of directors has declared an increase of 2.8% in the company’s quarterly cash dividend, beginning in the first quarter of 2022. The increase will result in a quarterly dividend of $0.73 per share of common stock. The dividend is payable on March 30, 2022, to stockholders of record at the close of business on March 15, 2022.

Gilead Sciences, Inc. Reaches Settlement with ViiV Healthcare Company, ViiV Healthcare UK (No.3) Limited, ViiV Healthcare UK Limited, Shionogi & Co., Ltd. and GlaxoSmithKline Mercury Limited

2022-02-01 21:03:00

On February 1, 2022, Gilead Sciences, Inc. (the Company), reached an agreement (the Settlement) with ViiV Healthcare Company, ViiV Healthcare UK (No.3) Limited, ViiV Healthcare UK Limited, Shionogi & Co., Ltd. and GlaxoSmithKline Mercury Limited (collectively, ViiV) for a global resolution of all pending or potential claims related to the Company’s sales of Biktarvy ®, including the previously disclosed litigations pending in the U.S. District Court for the District of Delaware and other jurisdictions outside the United States. Pursuant to the terms of the Settlement, ViiV grants Gilead a broad worldwide license and covenant not to sue relating to any past, present or future development or commercialization of bictegravir. In connection with the Settlement, the Company will  make a one-time payment to ViiV of $1.25 billion in the first quarter of 2022, and provide ViiV an ongoing royalty at a rate of 3% on future sales of Biktarvy® and the bictegravir component of bictegravir-containing products in the United States until October 5, 2027. In connection with the Settlement, the Company has recorded a pre-tax charge of $1.25 billion to Cost of goods sold for the fourth quarter of 2021.

Gilead Sciences, Inc. - Special Call

2022-02-01 21:02:00

Oncology Deep Dive

Gilead Sciences, Inc. Provides Earnings Guidance for the Full Year 2022

2022-02-01 21:02:00

Gilead Sciences, Inc. provided earnings guidance for the full year 2022. For the period, the company expects total product sales to be between $23.8 billion and $24.3 billion. Earnings per share to be between $4.70 and $5.20.

Pardes Biosciences, Inc. has closed its Shelf Registration dated January 21, 2022 in the amount of $521.617337 million.

2022-02-01 00:00:00

Pardes Biosciences, Inc. has closed its Shelf Registration dated January 21, 2022 in the amount of $521.617337 million. Security Name: Common Stock Securities Offered: 39,757,419

U.S. FDA Approves New Label Update for Car T-Cell Therapy Yescarta® Showing Prophylactic Steriod Use Improves Management of Cytokine Release Syndrome

2022-01-31 14:00:00

Gilead Company announced the U.S. Food and Drug Administration (FDA) has approved an update to the prescribing information for Yescarta® to include use of prophylactic corticosteroids across all approved indications. Yescarta is now the first and only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects. The label update is based on the results of a new safety management cohort (Cohort 6) of the pivotal ZUMA-1 study, which was designed to assess the impact of prophylactic use of corticosteroids and earlier treatment with corticosteroids and/or tocilizumab and prophylactic levetiracetam on the incidence and severity of cytokine release syndrome and neurologic events. In the cohort, no Grade =3 CRS events occurred [0% (0/39) of patients in Cohort 6 compared to 13% (14/108) in the pivotal Cohorts 1/2]. Grade =3 neurologic events occurred in 13% of patients at the time of data cut-off, and one patient experienced a late onset Grade 5 event following the data cut-off [13% (5/39) of patients in Cohort 6 compared to 31% (33/108) in the pivotal Cohorts 1/2]. Cohort 6 shows CRS median time to onset of five days with a range from 1-15 days, and neurotoxicity median time to onset of six days with a range from 1-274 days in patients that experienced these complications. Additional data recently published shows 68% of patients had no CRS or neurologic events within 72 hours of Yescarta infusion (27/40).1 Helping to address the potential concern that steroid use might impact efficacy, the Cohort 6 one-year update presented at the American Society of Hematology in December 2021 suggest that Cohort 6 toxicity management strategy can improve certain adverse events without compromising the activity of Yescarta. Patients in Cohort 4 and Cohort 6 were found to have received median cumulative steroid doses that were lower than those used in matched Cohorts 1/2 who received steroids to manage CRS or neurologic events when they occurred. The ZUMA-1 study also included Cohort 4 which was added to the FDA label in May 2021 and evaluated the earlier treatment with corticosteroids and/or tocilizumab and prophylactic levetiracetam. Cohort 6 builds on this growing knowledge regarding how to manage and minimize side effects gained over many years of developing Yescarta. Cohort 6 evaluated 39 patients with relapsed or refractory LBCL. Patients received dexamethasone 10 mg orally once daily for three days, starting prior to Yescarta infusion. In Cohort 6, corticosteroids and tocilizumab were started earlier, at lower grades of CRS and neurologic events, than in the ZUMA-1 pivotal cohorts (Cohorts 1 and 2). All 39 patients received three prophylactic doses of corticosteroids. Patients can currently access Kite’s CAR T-cell therapies through 111 authorized treatment centers across the U.S. that are experienced in administering and managing patients being treated with CAR T-cell therapy. The Yescarta prescribing information does not specify a treatment setting, whether in the hospital or in near-by outpatient offices with close monitoring. It is up to a patient’s physician to determine the most appropriate treatment setting for their care based on individual circumstances. The Yescarta label update may help physicians manage potential complications and determine appropriate setting for care of their patients. Yescarta was the first CAR T-cell therapy to be approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Yescarta is also currently under review in the U.S. and European Union for use as an earlier treatment of adult patients with second-line relapsed or refractory LBCL. Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy currently indicated for the treatment of: Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial.

Gilead Sciences, Inc., Q4 2021 Earnings Call, Feb 01, 2022

2022-01-18 21:05:00

Gilead Sciences, Inc., Q4 2021 Earnings Call, Feb 01, 2022

Gilead Sciences, Inc. to Report Q4, 2021 Results on Feb 01, 2022

2022-01-18 21:05:00

Gilead Sciences, Inc. announced that they will report Q4, 2021 results After-Market on Feb 01, 2022

Pardes Biosciences, Inc. announced that it has received $75 million in funding from a group of investors

2021-12-23 00:00:00

On December 23, 2021, Pardes Biosciences, Inc. closed the transaction.

Gilead Sciences, Inc. Announces Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns

2021-12-22 00:12:00

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-exposure prophylaxis (PrEP). The FDA’s clinical hold is due to emerging concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution, which could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir. Dosing of oral formulations of lenacapavir will continue. The company remains confident about the future potential of lenacapavir and is committed to resolving this vial quality issue. During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir will not be permitted across all lenacapavir studies. All other study activities, including the monitoring of participants and the dosing of participants in comparator arms, will continue according to the relevant study protocol.

Gilead Sciences, Inc. and Arcus Biosciences, Inc. Complete Closing of Option Exercise for Three Clinical-Stage Programs and New Research Collaboration

2021-12-21 21:35:00

Gilead Sciences, Inc. and Arcus Biosciences, Inc. announced the closing of Gilead’s option exercises to three programs in Arcus’s clinical-stage portfolio and a new research collaboration between the two companies. On November 17, 2021, Gilead exercised its options to anti-TIGIT molecules domvanalimab and AB308, as well as clinical candidates etrumadenant (dual adenosine A2a/A2b receptor antagonist) and quemliclustat (small molecule CD73 inhibitor). The closing occurred following the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Under the terms of the parties’ Option, License and Collaboration Agreement, as amended in connection with Gilead’s three option exercises (the “2020 Agreement”), the closing of this transaction triggers option payments totaling $725 million from Gilead to Arcus, expected to be paid in early first quarter of 2022. With closing of the transaction for all three programs, the $100 million option continuation payment previously due in third quarter of 2022 will not be made by Gilead. In addition, the parties will co-develop and share the global costs related to these clinical programs. If the optioned molecules achieve regulatory approval, Gilead and Arcus will co-commercialize and equally share profits in the U.S. Outside of the U.S., Gilead holds exclusive commercialization rights, subject to any rights of Arcus’s existing collaboration partners, and Gilead would pay Arcus tiered royalties on net sales of each optioned product.

Gilead Sciences, Inc. Announces European Commission Approves Variation to the Conditional Marketing Authorization for Veklury® (Remdesivir) to Include Adults

2021-12-21 09:00:00

Gilead Sciences, Inc. announced that the European Commission (EC) has approved a variation to the Conditional Marketing Authorization for Veklury® (remdesivir) to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19. This decision follows the positive recommendation of the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), to expand the indication for Veklury on December 16. The EC’s decision is supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. In the study, no deaths were observed in either arm by Day 28. The safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment emergent adverse events (=5%) in patients taking Veklury being nausea and headache. These data have also been shared with other regulatory agencies around the world and submitted for scientific peer-reviewed publication. This expanded indication in the EU adds to the previous Conditional Marketing Authorization of Veklury enabling the treatment of COVID-19 in adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment). In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. The use of Veklury for the treatment of non-hospitalized patients with three days of dosing in the U.S. is investigational, and the safety and efficacy for this use and dosing duration have not been approved by the U.S. Food and Drug Administration (FDA). Veklury is contraindicated in patients who are allergic to Veklury or any of its components.

Kite and Daiichi Sankyo Company, Limited Announces YESCARTA (Axicabtagene Ciloleucel), A Chimeric Antigen Receptor (Car) T-Cell Therapy

2021-12-16 23:00:00

Kite and Daiichi Sankyo Company, Limited announced that YESCARTA (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, will be available to patients with relapsed or refractory large B-cell lymphomas in Japan through the first treatment center now authorized by Daiichi Sankyo. Kite and Daiichi Sankyo will also build on the exclusive licensing deal for commercialization rights for axicabtagene ciloleucel in Japan, formalized in January 2017. Both partners are pleased to agree on a broadening of their business collaboration in Japan. CAR T-cell therapy is a complex immunotherapy, and all hospitals must complete a rigorous training process before administering axicabtagene ciloleucel to patients. These hospitals receive specific training in handling and risk minimization procedures in order to ensure that patient safety remains a priority. Several factors are considered when qualifying a hospital, including their specialist skills and services, geographic coverage and experience in managing other complex procedures, such as stem cell transplantation and a co-located intensive care unit. Axicabtagene ciloleucel has been approved in Japan for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B-cell lymphoma. The use of axicabtagene ciloleucel is limited to patients not previously treated with a CD-19 CAR-positive T-cell infusion; patients previously treated with two or more lines of treatment including chemotherapy or an autologous stem cell transplant; and, patients ineligible for an autologous stem cell transplant. In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan from California-based Kite, a Gilead Company. The approval of axicabtagene ciloleucel in Japan is based on data from the global pivotal trial conducted by Kite (ZUMA-1)2 and results of a Phase 2 study conducted by Daiichi Sankyo in Japan. In the Japanese Phase 2, open-label, single-arm study, the same dose (2.0 x 106 cells/kg) of axicabtagene ciloleucel as used in the ZUMA-1 study was administered to assess efficacy and safety in 16 Japanese patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B-cell lymphoma. The study reached its primary endpoint, demonstrating an objective response rate (ORR) of 86.7% (95% CI: 59.5 – 98.3%). The overall safety and tolerability profile of axicabtagene ciloleucel in the Japan trial was consistent with that observed in ZUMA-1. Dose limiting toxicity was not observed. Grade =3 treatment emergent adverse event occurred in all patients; most commonly neutropenia (81.3%), lymphopenia (81.3%) and thrombocytopenia (62.5%). Cytokine release syndrome (CRS), a typical CAR T-cell therapy-emergent adverse event, occurred in 13 patients (81.3%, all Grade), with Grade =3 CRS in one patient (6.3%). No neurological events, another CAR T-cell therapy-emergent adverse event, were observed.

Kite Announces Primary Results from ZUMA-12, Global, Multicenter, Single-Arm, Open-Label Phase 2 Study Evaluating Yescarta

2021-12-13 19:45:00

Kite, a Gilead Company announced primary results from ZUMA-12, a global, multicenter, single-arm, open-label Phase 2 study evaluating Yescarta as part of first-line treatment in patients with high-risk large B-cell lymphoma. This is the first study to evaluate CAR T-cell therapy as part of first-line therapy in high-risk LBCL. The study is based on the desire to utilize potential curative treatment as quickly as possible and the hypothesis that earlier use of CAR T-cell therapy when T cells are healthier may produce better outcomes. The data were presented in an oral session during the 63rdAmerican Society of Hematology Annual Meeting & Exposition. After a single infusion of Yescarta, 89% of evaluable patients achieved a response (ORR) (n=37 evaluable for efficacy), including 78% of patients with a complete response at a median follow-up of 15.9 months. CR rate was consistent among key subgroups. Among evaluable patients, median time to response was one month. At time of data cut-off, 73% of evaluable patients had ongoing responses. Medians for duration of response, event-free survival. and progression-free survival were not yet reached, with 12-month estimates of 81%, 73%, and 75%, respectively, and an estimated 12-month OS rate of 91%. Yescarta was successfully manufactured for all 42 enrolled patients with a median turnaround time of 18 days between leukapheresis and delivery to the trial site for treated patients. Levels of CCR7+CD45RA+ T cells (a measure of T-cell fitness) found in pre-infused product were more than double what was measured in the heavily pre-treated third line ZUMA-1 patient population. Levels of CCR7+CD45RA+ T cells in pre-infused product have been associated with a favorable pharmacokinetic (PK) profile. CAR T-cell expansion also appeared greater in ZUMA-12 compared with ZUMA-1. Among all treated patients (n=40), safety observations were consistent with the known safety profile for Yescarta. Grade 3 cytokine release syndrome occurred in of patients and Grade =3 neurologic events occurred in of patients. No Grade 5 CRS or neurological events occurred. There was one Grade 5 adverse event due to COVID-19. All CRS cases and most neurologic events of any grade resolved by the time of data cut-off. Yescarta has not been approved by any regulatory agency for the treatment of patients in the first-line setting. See About Yescarta section for current Yescarta approved indications. ZUMA-12 is a multicenter, open-label, single-arm Phase 2 study that enrolled 42 adult patients (=18 years old) with high-risk LBCL. Patients who met the following criteria for high-risk LBCL were considered eligible for the study: double- or triple-hit lymphoma by fluorescent in situ hybridization per investigator or LBCL with IPI score =3; and positive interim PET per Lugano Classification after two cycles of an anti-CD20 monoclonal antibody- and anthracycline-containing regimen. Patients underwent leukapheresis and optional non-chemotherapy bridging at investigator discretion, followed by conditioning chemotherapy. The primary endpoint of the trial is complete response rate per the Lugano Classification. Key secondary objectives include objective response rate, duration of response, event-free survival, progression-free survival, overall survival, frequency of adverse events, and levels of CAR T cells and cytokines in blood and serum. The study is ongoing.

Gilead Company Announces Results from the Primary Analysis of Zuma-7

2021-12-11 13:30:00

Kite, a Gilead Company announced results from the primary analysis of ZUMA-7, a global Phase 3 study evaluating Yescarta® (axicabtagene ciloleucel) as a one-time infusion, in a head-to-head study against standard of care (SOC) for adults with large B-cell lymphoma (LBCL) who relapsed or were refractory to first-line treatment. Yescarta was evaluated against the current SOC which is a multi-step process intended to culminate in a stem cell transplant. ZUMA-7 was initiated in 2017 and is the first and large Phase 3 randomized study of any CAR T-cell therapy in the second-line setting, enrolling 359 patients in 77 centers around the world. ZUMA-7 is considered trial for being the only study to reach the clinically meaningful two-year follow-up milestone. The findings were featured in the American Society of Hematology (ASH) press briefing at their 63rd ASH Annual Meeting & Exposition and in a simultaneous publication in the New England Journal of Medicine (NEJM). The data will also be presented in full at the ASH plenary session on Sunday, December 12 (Abstract #2). With a median follow-up of over two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398; 95% CI: 0.308-0.514, P<0.0001). Yescarta demonstrated a 2.5 fold increase in patients who were alive at two years and did not require the need for additional cancer treatment or experienced cancer progression (40.5% vs. 16.3%) and a four-fold greater median EFS (8.3 mo. vs. 2.0 mo.) compared to SOC. These statistically significant and clinically meaningful results were not confounded by any bridging chemotherapy. Improvements in EFS with Yescarta were consistent across key patient subgroups, including the elderly (HR: 0.276 [95% CI: 0.164-0.465]), primary refractory disease (HR: 0.426 [95% CI: 0.319-0.570]), high-grade B-cell lymphoma including double-hit and triple-hit lymphoma (HGBL; HR: 0.285 [95% CI: 0.137-0.593]), and double expressor lymphoma (HR: 0.424 [95% CI: 0.268-0.671]). In ZUMA-7, nearly three times as many patients randomized to Yescarta ultimately received the definitive CAR T-cell therapy treatment (94%) versus those randomized to SOC (36%) who received HDT+ASCT. Among randomized patients, overall response (ORR) and complete response (CR) rates were also higher with Yescarta (ORR: 83% vs. 50%, odds ratio: 5.31 [95% CI: 3.1-8.9; P<0.0001]; CR rate: 65% vs. 32%). Median overall survival (OS), evaluated as a preplanned interim analysis, favored Yescarta compared to SOC (not reached vs. 35.1 months, respectively). The primary analysis of OS will occur at approximately 210 deaths. In a separate ZUMA-7 analysis of patient-reported outcomes (PROs) which will also be shared in an ASH oral presentation on December 12 (Abstract #430), patients receiving Yescarta and eligible for the PROs portion of the study (n=165) showed significant and clinically meaningful improvements in quality of life (QoL) at Day 100 compared with those who received SOC (n=131) using a prespecified analysis for three PRO domains (EORTC QLQ-C30 Physical Functioning, EORTC QLQ-C30 Global Health Status/QOL, and EQ-5D-5L visual analog scale [VAS]). The data also suggest faster recovery to pretreatment QoL for patients treated with Yescarta versus SOC. In the ZUMA-7 trial, Yescarta had a manageable safety profile that was consistent with previous studies. Among the 170 Yescarta-treated patients evaluable for safety, Grade =3 cytokine release syndrome (CRS) and neurologic events were observed in 6% and 21% of patients, respectively. No Grade 5 CRS or neurologic events occurred. In the SOC arm, 83% of patients had high grade events, mostly cytopenias (low blood counts). Global regulatory filings to expand the indication for Yescarta to include second-line relapsed or refractory LBCL based on the ZUMA-7 data are currently underway. The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation to Yescarta for this patient population with a target action date under the Prescription Drug User Fee Act (PDUFA) of April 1, 2022. Regulatory submissions have also been filed with other global health authorities, including the European Medicines Agency (EMA).

Gilead Sciences, Inc. Announces Trodelvy® Demonstrates Clinical Benefit for Black Patients Consistent with Full Metastatic Triple-Negative Breast Cancer Population in ASCENT Study

2021-12-10 13:00:00

Gilead Sciences, Inc. announced new data from the Phase 3 ASCENT study evaluating Trodelvy® (sacituzumab govitecan-hziy) in relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In this subgroup analysis of Black patients, Trodelvy improved progression-free survival (PFS), with a 56% reduction in the risk of disease worsening or death (HR: 0.44; 95% CI: 0.24-0.80; P=0.008) and a median PFS of 5.4 months (n=28) versus 2.2 months with chemotherapy (n=34). Trodelvy also extended median overall survival to 13.8 months versus 8.5 months with physician’s choice of chemotherapy (HR: 0.64; 95% CI: 0.34-1.19; P=0.159). The results were presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) (Poster #P5-16-07). TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. Black women have three times the risk of TNBC as white women, and a 42% higher mortality rate from breast cancer overall. The five-year survival rate for this sub-type of breast cancer is 12%, compared with 28% for other breast cancer types, and these poor outcomes are often coupled with a significant decrease in quality of life, especially in relapsed/refractory disease. Additionally, Trodelvy demonstrated a higher overall response rate (32% versus 6%) and clinical benefit rate (43% versus 15%) compared with physician’s choice of chemotherapy in this subgroup. Efficacy and safety results from this subgroup were consistent with those observed in the overall ASCENT study population. The most frequent Grade =3 treatment-related adverse reactions for Trodelvy compared to chemotherapy were neutropenia (48% versus 42%), anemia (12% versus 6%), leukopenia (8% versus 16%), and febrile neutropenia (8% versus 3%). In this subgroup, no patients in the Trodelvy arm and one patient in the chemotherapy arm discontinued treatment due to adverse reactions. There were no treatment-related deaths with Trodelvy in this subgroup. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information. The ASCENT study is a global, open-label, randomized Phase 3 study that enrolled more than 500 patients across 230 study locations. The study evaluated the efficacy and safety of Trodelvy compared with a single-agent chemotherapy of the physician’s choice in patients with unresectable, locally advanced or metastatic TNBC who had received at least two prior systemic treatments. Patients were randomized to receive either Trodelvy or a chemotherapy chosen by the patients’ treating physicians. The primary endpoint was progression-free survival (PFS, as determined by blinded independent central review) in patients without brain metastases. Secondary endpoints included: PFS for full study population or intention-to-treat (ITT) population, overall survival in both the ITT population and in the subgroup without brain metastasis, independently determined objective response rate, duration of response, time to onset of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), quality of life and safety.

Drug Information Association, Inc., DIA Global Annual Meeting 2022, Jun 19, 2022 through Jun 23, 2022

2021-12-10 06:32:00

Drug Information Association, Inc., DIA Global Annual Meeting 2022, Jun 19, 2022 through Jun 23, 2022. Venue: Chicago, Illinois, United States.

Gilead Sciences, Inc. Receives Grant from European Commission for Trodelvy®

2021-11-23 13:30:00

Gilead Sciences, Inc. announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan), a first-in-class Trop-2-directed antibody-drug conjugate, as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease. TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. The five-year survival rate for this sub-type of breast cancer is 12%, compared with 28% for other breast cancer types, and these poor outcomes are often coupled with a significant decrease in quality of life, especially in relapsed/refractory disease. The EC’s decision is supported by results from the Phase 3 ASCENT study, where Trodelvy reduced the risk of death by 49% and improved median overall survival to 11.8 months versus 6.9 months with physician’s choice of chemotherapy (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001). These data also showed a statistically significant and clinically meaningful 57% reduction in the risk of death or disease worsening and improved median progression free survival (PFS) to 4.8 months from 1.7 months seen with physician’s choice of chemotherapy alone among all randomized patients, which included those with and without brain metastases (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). The most common Grade 3 or higher adverse reactions were neutropenia (49.5%), leukopenia (12.0%), diarrhea (10.7%), anemia (10.1%), febrile neutropenia (6.6%), fatigue (5.2%), hypophosphatemia (5.2%), nausea (4.1%) and vomiting (3.0%).8 The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information. In addition to this approval, Trodelvy is approved in Australia, Canada, Great Britain, Switzerland, and the United States in metastatic TNBC. Regulatory review is also underway in Singapore and China with applications submitted by Everest Medicines. Trodelvy was also recently included in the updated ESMO Clinical Practice Guidelines as a preferred treatment option for metastatic TNBC after taxanes. About the ASCENT Study: The ASCENT study is a global, open-label, randomized Phase 3 study that enrolled more than 500 patients across 230 study locations. The study evaluated the efficacy and safety of Trodelvy compared with a single-agent chemotherapy of the physician’s choice in patients with unresectable, locally advanced or metastatic TNBC who had received at least two prior systemic treatments. Patients were randomly allocated to receive either Trodelvy or a chemotherapy chosen by the patient’s treating physician. The primary endpoint was progression-free survival (PFS, as determined by blinded independent central review) in patients without brain metastases. Secondary endpoints included: PFS for full study population or intention-to-treat (ITT) population, overall survival in both the ITT population and in the subgroup without brain metastasis, independently determined objective response rate, duration of response, time to onset of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), quality of life and safety. About Triple-Negative Breast Cancer (TNBC): TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer. About Trodelvy: Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Trodelvy is approved in second-line metastatic TNBC in multiple countries worldwide, including Australia, Canada, Great Britain, the European Union, Switzerland and the United States. Trodelvy is also approved for use in metastatic UC in the United States. Trodelvy continues to be developed for potential use in other TNBC and metastatic UC populations and is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

Gilead Sciences, Inc. Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide

2021-11-19 13:00:00

Gilead Sciences, Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease; bulevirtide has been granted Breakthrough Therapy and Orphan Drug designations by the FDA. Bulevirtide is an investigational agent in the U.S. and the safety and efficacy have not been established. The BLA submission is supported by data from completed and ongoing Phase 2 studies and the ongoing Phase 3 MYR301 study which supports the safety and efficacy of bulevirtide 2 mg once daily after 24 weeks of therapy. In Europe, Hepcludex® (bulevirtide) has been granted Conditional Marketing Authorization by the European Commission and PRIority MEdicines scheme eligibility by the European Medicines Agency (EMA), as the first approved treatment in Europe for adults with chronic HDV infection with compensated liver disease. Interim results from the Phase 3 MYR301 study indicate that after 24 weeks of therapy, the proportion of people with HDV infection achieving the combined virological and biochemical response was 36.7% with bulevirtide 2 mg, 28% in participants receiving bulevirtide 10 mg and 0% in participants currently under observation who have not received antiviral treatment at this stage of the study. Treatment for 24 weeks with bulevirtide 2 mg had a statistically significant response (p<0.001) as compared to the no treatment group. Additionally, rapid alanine aminotransferase (ALT) reduction and normalization were observed in >50% of people with HDV in the bulevirtide 2 mg group compared with the no treatment group (5.9%). These results reinforce the efficacy of bulevirtide observed in completed Phase 2 studies for the treatment of HDV. Based on these interim results, the safety profile of bulevirtide at 24 weeks is consistent with previously completed clinical studies. No serious adverse events (AEs), symptomatic elevations in bile salts or AEs leading to discontinuation related to bulevirtide were reported. The most common AEs observed with bulevirtide are raised levels of bile salts in the blood (which may affect more than 1 in 10 people), reactions at the site of injection (which may affect up to 1 in 10 people) and worsening of liver disease after stopping bulevirtide (which may affect up to 1 in 10 people).

Gilead Sciences, Inc. Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Dec-02-2021 02:40 PM

2021-11-18 21:05:00

Gilead Sciences, Inc. Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Dec-02-2021 02:40 PM.

Gilead Exercises Options to Three Arcus Biosciences Clinical-Stage Programs and Adds Research Collaboration

2021-11-18 12:00:00

Gilead Sciences, Inc. and Arcus Biosciences, Inc. announced that Gilead has exercised its options to three programs in Arcus’s clinical-stage portfolio, including both anti-TIGIT molecules, domvanalimab and AB308, as well as etrumadenant and quemliclustat. Domvanalimab is an Fc-silent anti-TIGIT antibody in Phase 2 and Phase 3 studies in non-small cell lung cancer (NSCLC) and AB308 is an Fc-enabled anti-TIGIT antibody under Phase 1 evaluation. Etrumadenant is a dual adenosine A2a/A2b receptor antagonist in Phase 1 and Phase 2 studies in NSCLC, colon cancer and prostate cancer. Quemliclustat is a small molecule CD73 inhibitor in a Phase 1 study in metastatic pancreatic ductal adenocarcinoma (PDAC). Gilead has been encouraged by early clinical data generated for each of the three programs. By opting in early to all three programs now, Gilead and Arcus are able to accelerate the clinical development and advancement of these clinical-stage molecules and facilitate the exploration of treatment combinations across the portfolios. For example, Gilead will be able to pursue potential chemotherapy-free regimens with Trodelvy® (sacituzumab govitecan-hziy) in combination with therapies optioned from the Arcus portfolio. Gilead will also have the flexibility to add Gilead portfolio candidates to existing Arcus studies. Under the terms of the parties’ Option, License and Collaboration Agreement (the “2020 Agreement”), for the three options that Gilead is exercising today, Arcus will receive option payments totaling $725 million. The parties will co-develop and share the global costs related to these programs. If the optioned molecules achieve regulatory approval, Gilead and Arcus will co-commercialize and equally share profits in the U.S. Gilead will hold exclusive rights outside the U.S., subject to any rights of Arcus’s existing collaboration partners, and Gilead will pay to Arcus tiered royalties.

Everest Medicines and Gilead Sciences Jointly Announce Phase 2B Study of Sacituzumab Govitecan Conducted in China of Patients with Metastatic Triple-Negative Breast Cancer Meets Primary Overall Response Rate Endpoint

2021-11-11 00:05:00

Everest Medicines and Gilead Sciences, Inc. jointly announced that Everest Medicines' Phase 2b EVER-132-001 study of sacituzumab govitecan (marketed as Trodelvy® in the United States) met its primary endpoint of overall response rate (ORR) in metastatic triple-negative breast cancer (TNBC). EVER-132-001 is a single-arm, multi-center Phase 2b registrational study evaluating sacituzumab govitecan in 80 patients enrolled in China for the treatment of adults with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one for metastatic disease. The results demonstrated an ORR of 38.8% (CI: 95%) as evaluated by an Independent Review Committee. The safety profile of sacituzumab govitecan was similar to that reported in prior studies, and no new safety signals were identified. The primary endpoint measured ORR according to RECIST v1.1 by an Independent Review Committee. The results were consistent with results demonstrated in the global Phase 3 ASCENT study. Gilead and Everest Medicines are engaged in a joint partnership for the development and commercialization of sacituzumab govitecan in Asia. In May 2020, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) granted priority review to the Biologics License Application (BLA) for sacituzumab govitecan for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022

2021-11-09 17:12:00

Biotechnology Innovation Organization, BIO International Convention 2022, Jun 13, 2022 through Jun 16, 2022. Venue: San Diego Convention Center, San Diego, California, United States.

Gilead Sciences, Inc. Presents at BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov-08-2021 01:30 PM

2021-11-04 13:52:00

Gilead Sciences, Inc. Presents at BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov-08-2021 01:30 PM. Speakers: Bill Grossman, SVP, Merdad V. Parsey, Chief Medical Officer.

Gilead Sciences, Inc. Presents at Pharma/Biotech GTN Summit, Nov-19-2021 09:45 AM

2021-11-03 17:32:00

Gilead Sciences, Inc. Presents at Pharma/Biotech GTN Summit, Nov-19-2021 09:45 AM. Venue: Hilton Penn's Landing Hotel, Philadelphia, Pennsylvania, United States. Speakers: Chris Haro, Associate Director, U.S. Revenue Accounting.

Gilead Sciences, Inc. Presents at 5th Annual NASH Summit, Nov-29-2021 through Dec-02-2021

2021-11-03 08:15:00

Gilead Sciences, Inc. Presents at 5th Annual NASH Summit, Nov-29-2021 through Dec-02-2021. Presentation Date & Speakers: Dec-01-2021, Archana Vijaykumar, Senior Research Scientist. Dec-02-2021, Andrew Billin, Senior Director - Biomarker Sciences. Nov-30-2021, Andrew Billin, Senior Director - Biomarker Sciences, Archana Vijaykumar, Senior Research Scientist, James Trevaskis, Senior Director of Biology & Head of Fibrosis Research.

Hanson Wade Limited, 5th Annual NASH Summit, Nov 29, 2021 through Dec 02, 2021

2021-11-03 06:30:00

Hanson Wade Limited, 5th Annual NASH Summit, Nov 29, 2021 through Dec 02, 2021.

BMO Capital Markets Corp., BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov 08, 2021

2021-11-01 12:00:00

BMO Capital Markets Corp., BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov 08, 2021.

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022

2021-10-29 14:57:00

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022. Venue: New York, New York, United States.

Gilead Sciences, Inc. Announces Interim Results from the Ongoing, Multinational, Observational Single-Arm, Non-Comparative Real-World Cohort BICSTaR Study

2021-10-29 11:30:00

Gilead Sciences, Inc. announced interim results from the ongoing, multinational, observational single-arm, non-comparative real-world cohort BICSTaR study, which is designed to evaluate the antiviral effectiveness and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in 1,135 people living with HIV. The BICSTaR study also collected patient-reported outcomes in routine clinical practice to better understand the impact of treatment on health-related quality of life in people living with HIV. These data were presented at the 18th European AIDS Conference (EACS 2021). Gilead presented an analysis of patient-reported outcomes after 12 months of treatment with Biktarvy from the BICSTaR study. During the study, conducted at sites in Europe, Canada and Israel, people living with HIV who initiated treatment with Biktarvy between June 2018 and September 2020 completed questionnaires at baseline and 12 months. The questionnaires assessed patient-reported outcomes covering a range of measures. The results underline the importance of collecting patient-reported outcomes in order to understand the impact on mental health status, health-related quality of life and treatment satisfaction of people living with HIV. In a second analysis of the BICSTaR study, 97% (n=149/154) of treatment-naïve adults and 96% (n=771/800) of treatment-experienced adults achieved and maintained virologic suppression (HIV-1 RNA <50 copies/mL) after one year of treatment. Participants included adults 50 years of age or older, cisgender women, and late presenters (CD4 <200 cells/µl and/or =1 AIDS-defining event at baseline). Both treatment-naïve and treatment-experienced participants had high persistence with Biktarvy (91%, n=1032/1135) across both groups, Biktarvy was generally well-tolerated and no resistance to the components of Biktarvy emerged. 148 (13%) participants had any adverse event and 2 (<1%) had a serious adverse event. The most common drug-related adverse events observed to date in the BICSTaR study were weight increase (3%), nausea (1%), depression (1%), headache (1%), fatigue (1%), diarrhoea (1%) and sleep disorder (1%). These large cohort findings continue to reinforce the real-world effectiveness of Biktarvy across populations and are consistent with evidence from randomized clinical trials. Additional Biktarvy data presented at EACS 2021 include a Phase 3 trial (Study 1878) that demonstrated the durable efficacy of Biktarvy. In the study, 99% of people living with HIV who switched to Biktarvy from a boosted protease inhibitor-based regimen maintained and achieved long-term viral suppression through a median of 101 weeks (n=525/532), including 98% of participants with pre-existing resistance (n=212/217; median of 108 weeks) and 98% of participants with viral blips (n=39/40; median of 109 weeks), with no treatment-emergent resistance to Biktarvy. A pooled analysis of five Phase 3 studies (1844, 1878, 4030, 4449, 4580) also found that regardless of pre-existing TAMS (thymidine analog-associated mutations M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E), a high proportion of those on Biktarvy were able to maintain virologic suppression and had an absence of treatment-emergent resistance. These data support the continued evaluation of Biktarvy as a potential option for virologically suppressed people living with HIV with known resistance. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.

Gritstone bio, Inc. has closed its Shelf Registration dated October 15, 2021 in the amount of $46.85 million.

2021-10-29 00:00:00

Gritstone bio, Inc. has closed its Shelf Registration dated October 15, 2021 in the amount of $46.85 million. Security Name: Common Stock Securities Offered: 5,000,000

Gilead Sciences, Inc. Announces Clinical Trial Collaboration with Merck & Co., Inc. to Evaluate Trodelvy (Sacituzumab Govitecan-Hziy) in Combination with KEYTRUDA® (Pembrolizumab) in Patients with First-Line Metastatic Triple-Negative Breast Cancer

2021-10-28 20:10:00

Gilead Sciences, Inc. announced it has entered into a clinical trial collaboration and supply agreement with Merck to evaluate the efficacy of Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy® (sacituzumab govitecan-hziy) in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), as a first-line treatment for patients with locally advanced or metastatic triple-negative breast cancer (TNBC). Under the terms of the agreement, Gilead will sponsor a global Phase 3 clinical trial to evaluate Trodelvy in combination with KEYTRUDA compared to standard of care KEYTRUDA in combination with chemotherapy in first-line patients with locally advanced or metastatic TNBC. Metastatic TNBC has the worst survival rate among breast cancer subtypes, and there is an urgent need for new therapies that improve patient outcomes. Trodelvy is an antibody-drug conjugate that specifically targets Trop-2 expressing cells to enable local delivery of a cytotoxic payload that selectively kills the targeted cells. The combination of Trodelvy with an immune-stimulating agent such as KEYTRUDA could provide a novel regimen in first-line metastatic TNBC.

Gilead Sciences, Inc. Updates Earnings Guidance for the Full Year 2021

2021-10-28 20:10:00

Gilead Sciences, Inc. updated earnings guidance for the full year 2021. Total product sales between $26.0 billion and $26.3 billion, compared to $24.4 billion and $25.0 billion previously, reflecting year-to-date results and updated expectations for the fourth quarter 2021. Total product sales, excluding Veklury, of approximately $21.5 billion, compared to $21.7 billion and $21.9 billion previously, primarily reflecting the longer than expected pandemic impact on business. Total Veklury sales between $4.5 billion and $4.8 billion, compared to $2.7 billion and $3.1 billion previously, primarily reflecting the surge in COVID-19 hospitalizations in the third quarter 2021, and expectations for a significant step-down in hospitalization rates in the fourth quarter 2021. GAAP earnings per share between $5.50 and $5.70, compared to $4.70 and $5.05 previously.

Tranche Update on Gilead Sciences, Inc. (NasdaqGS:GILD)'s Equity Buyback Plan announced on February 2, 2016.

2021-10-28 16:10:00

From July 1, 2021 to September 30, 2021, the company has repurchased 2,063,980 shares, representing 0.16% for $145 million. With this, the company has completed the repurchase of 144,935,980 shares, representing 11.18% for $10,676.61 million under the buyback announced on February 2, 2016.

Tranche Update on Gilead Sciences, Inc. (NasdaqGS:GILD)'s Equity Buyback Plan announced on February 25, 2020.

2021-10-28 16:10:00

From July 1, 2021 to September 30, 2021, the company has repurchased 0 shares, representing 0% for $0 million. With this, the company has completed the repurchase of 0 shares, representing 0% for $0 million under the buyback announced on February 25, 2020.

Gilead Sciences, Inc. Presents at BioData World Congress 2021, Nov-02-2021 03:20 PM

2021-10-26 19:08:00

Gilead Sciences, Inc. Presents at BioData World Congress 2021, Nov-02-2021 03:20 PM. Speakers: OhKyu Yoon, Director, Clinical Bioinformatics.

Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for Hiv-1 Treatment in Virologically Suppressed Adults

2021-10-26 10:45:00

Gilead Sciences, Inc. and Merck known as MSD outside the United States and Canada, announced the start of a Phase 2 clinical study evaluating an investigational once-weekly oral combination treatment regimen of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy. Through the collaboration between Merck and Gilead, announced in March 2021, the companies seek to build on their legacies of transforming HIV care by focusing on long-acting therapies, which may represent a meaningful innovation in HIV drug development. Both islatravir and lenacapavir have long half-lives and have demonstrated activity at low dosages in independent clinical studies, which support the development as an investigational combination regimen with long-acting formulations, both oral and injectable. While daily, single tablet oral regimens are available for people living with HIV, oral or injectable regimen options that allow for less frequent dosing have the potential to address preference considerations, as well as issues associated with stigma, adherence, and privacy.

Gilead Sciences, Inc., $ 0.71, Cash Dividend, Dec-14-2021

2021-10-26 00:00:00

Gilead Sciences, Inc., $ 0.71, Cash Dividend, Dec-14-2021

Gilead Sciences, Inc. Presents Long-Term Switch Data Reinforcing Biktarvy as A Treatment Option for A Broad Range of People Living with HIV

2021-10-21 11:37:00

Gilead Sciences, Inc. announced the company’s upcoming contributions to the 18th European AIDS Conference (EACS 2021), taking place virtually and onsite in London from October 27-30. Forty-four studies from Gilead’s HIV research and development programs will be presented, including data from the global, observational, real-world BICSTaR study, which along with Gilead’s community-focused programs, reflect the company’s ongoing focus and commitment to advancing scientific discovery and supporting the development and delivery of practical solutions that can help improve care for all people affected by HIV. Gilead will present long-term safety and efficacy data evaluating outcomes in adults living with HIV who switched to Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) from boosted protease inhibitor-based regimens including in those with pre-existing resistance. The primary endpoint was at week 48; results of the open-label extension phase through a maximum of week 181 are slated for presentation at EACS 2021. The data further establish the robust and durable efficacy profile of Biktarvy as a treatment option for virologically suppressed people living with HIV with known resistance. The use of Biktarvy in individuals with known resistance to the components of Biktarvy is investigational. Twelve-month data and a descriptive analysis of patient-reported outcomes from the ongoing BICSTaR Study, a global, observational, real-world study evaluating the effectiveness, safety, and tolerability of Biktarvy in treatment-naïve and treatment-experienced people living with HIV, will be presented at the conference. As the population of persons living with HIV increases, the evaluation and management of comorbid conditions that may occur in an individual’s life takes on a larger role in HIV clinical care. These findings may help inform a future paradigm of coordinated, patient-centered HIV care. Additionally, at EACS 2021, Gilead will share new findings on long-acting HIV treatment strategies, as well as updates from the company’s continued pursuit of a cure for HIV. Data will include subgroup and resistance analyses from the ongoing Phase 3 CAPELLA trial evaluating the antiviral activity of investigational lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen in people living with HIV who are heavily treatment-experienced with multi-drug resistant HIV-1 infection. To further aid the development of a functional HIV cure, Gilead conducted a study using mathematical modelling and machine learning in a Phase 1b study to identify predictive immune biomarkers of HIV post-treatment controllers. HIV post-treatment controllers, a rare group of people who manage to sustain their viral load suppression after stopping antiretroviral therapy, have the potential to help further research and understand possible ways to induce a similar response to treatment in a broader group of people living with HIV. Beyond presenting new scientific data from the company’s HIV research and development programs, Gilead will convene a symposium featuring community, clinical and health systems experts to discuss the ongoing impact of COVID-19 on the HIV cascade of care and lessons learned that can be applied in the future as seek to accelerate the end of the HIV epidemic, work towards increased health equity, and prepare for future emerging viruses.

Gilead Sciences, Inc. Announces the U.S. FDA Approves a New Low-Dose Tablet Dosage form of Biktarvy

2021-10-18 11:30:00

Gilead Sciences, Inc. announced the U.S. Food and Drug Administration (FDA) approved a new low-dose tablet dosage form of Biktarvy® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy to include younger children living with HIV-1 infection and will help to close the gap between HIV treatment options available for adults and children. While effective available treatment options for pregnant women living with HIV lower the likelihood of perinatal HIV infection transmission, pediatric HIV remains a global health problem. Each day in 2020, approximately 850 children worldwide became infected with HIV and approximately 330 children died from AIDS-related causes, mostly because of inadequate access to HIV care and treatment services. The availability of a single-tablet antiretroviral regimen for children weighing at least 14 kg is a significant milestone with the potential to save many lives. In the United States, Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Biktarvy has a Boxed Warning for post treatment acute exacerbation of hepatitis B. The approval of Biktarvy for children weighing at least 14 kg is based on data from Cohort 3 of a Phase 2/3 open-label, single-arm study (NCT02881320 [1]), which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1. Cohort 3 enrolled 22 participants weighing =14 to U.S. Important Safety Information for Biktarvy.

Gilead Sciences, Inc.'s Sacituzumab Govitecan Receives Positive CHMP Opinion as 2L Treatment for Adult Patients With Metastatic Triple-Negative Breast Cancer

2021-10-15 12:00:00

Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for sacituzumab govitecan as monotherapy indicated for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease. The final European Commission decision on the Marketing Authorization Application for sacituzumab govitecan is anticipated later in 2021. TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. The five-year survival rate for this sub-type is 12%, compared with 28% for other breast cancer types, and these poor outcomes are often coupled with a significant decrease in quality of life, especially in relapsed/refractory disease. Sacituzumab govitecan is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a protein located on the surface of cells and is overexpressed in TNBC and many other tumors. The positive opinion is supported by results from the Phase 3 ASCENT study, where sacituzumab govitecan showed a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death and improved median progression-free survival (PFS) to 4.8 months from 1.7 months seen with physician’s choice of chemotherapy alone among all randomized patients, which included those with and without brain metastases (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Sacituzumab govitecan also reduced the risk of death by 49% and improved median overall survival to 11.8 months vs. 6.9 months with physician’s choice of chemotherapy (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001). The most common Grade 3 or higher adverse reactions were neutropenia (49.5%), leukopenia (12.0%), diarrhea (10.7%), anemia (10.1%), febrile neutropenia (6.6%), fatigue (5.2%), hypophosphatemia (5.2%), nausea (4.1%) and vomiting (3.0%). The sacituzumab govitecan U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information. Sacituzumab govitecan (under the trade name Trodelvy®) is approved in Australia, Canada, Great Britain, Switzerland, and the United States in metastatic TNBC, and review is also underway in Singapore and China through Everest Medicines. The ASCENT study is a global, open-label, randomized Phase 3 study that enrolled more than 500 patients across 230 study locations. The study evaluated the efficacy and safety of sacituzumab govitecan compared with a single-agent chemotherapy of the physician’s choice in patients with unresectable, locally advanced or metastatic TNBC who had received at least two prior systemic treatments. Patients were randomly allocated to receive either sacituzumab govitecan or a chemotherapy chosen by the patient’s treating physician. The primary endpoint was progression-free survival (PFS, as determined by blinded independent central review) in patients without brain metastases. Secondary endpoints included: PFS for full study population or intention-to-treat (ITT) population, overall survival in both the ITT population and in the subgroup without brain metastasis, independently determined objective response rate, duration of response, time to onset of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), quality of life and safety. TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer. Sacituzumab govitecan is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Beyond the approvals of sacituzumab govitecan in the United States, it is also approved for metastatic TNBC in Australia, Canada, Great Britain and Switzerland for adults with metastatic TNBC. Sacituzumab govitecan is also under multiple regulatory reviews worldwide, including the EU, as well as in Singapore and China through partner Everest Medicines. Sacituzumab govitecan continues to be developed for potential use in other TNBC and metastatic UC populations and is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

Gilead Sciences, Inc. Presents at AASLD The Liver Meeting, Nov-12-2021

2021-10-15 04:09:00

Gilead Sciences, Inc. Presents at AASLD The Liver Meeting, Nov-12-2021 . Speakers: Robert P. Myers.

Gritstone bio, Inc. has filed a Shelf Registration in the amount of $46.85 million.

2021-10-15 00:00:00

Gritstone bio, Inc. has filed a Shelf Registration in the amount of $46.85 million. Security Name: Common Stock Securities Offered: 5,000,000

Gilead Sciences, Inc., Q3 2021 Earnings Call, Oct 28, 2021

2021-10-14 20:05:00

Gilead Sciences, Inc., Q3 2021 Earnings Call, Oct 28, 2021

Gilead Sciences, Inc. to Report Q3, 2021 Results on Oct 28, 2021

2021-10-14 20:05:00

Gilead Sciences, Inc. announced that they will report Q3, 2021 results After-Market on Oct 28, 2021

Gilead Sciences, Inc. Presents at 2021 Veeva R&D and Quality Summit Connect, Oct-14-2021 11:30 AM

2021-10-13 14:20:00

Gilead Sciences, Inc. Presents at 2021 Veeva R&D and Quality Summit Connect, Oct-14-2021 11:30 AM. Speakers: Valerie Brown, SVP, Quality Assurance.

Gilead Sciences, Inc. Presents at TIGIT Therapies Digital Summit, Dec-07-2021

2021-10-12 17:24:00

Gilead Sciences, Inc. Presents at TIGIT Therapies Digital Summit, Dec-07-2021 . Speakers: Sandhya Girish, Vice President Clinical Pharmacology, Sreeneeranj Kasichayanula, Senior Director Clinical Pharmacology.

Hanson Wade Limited, TIGIT Therapies Digital Summit, Dec 07, 2021 through Dec 09, 2021

2021-10-12 06:21:00

Hanson Wade Limited, TIGIT Therapies Digital Summit, Dec 07, 2021 through Dec 09, 2021.

Terrapinn Holdings Ltd, BioData World Congress 2021, Nov 02, 2021 through Nov 04, 2021

2021-10-06 12:29:00

Terrapinn Holdings Ltd, BioData World Congress 2021, Nov 02, 2021 through Nov 04, 2021.

Informa plc, Pharma/Biotech GTN Summit, Nov 17, 2021 through Nov 19, 2021

2021-10-05 06:37:00

Informa plc, Pharma/Biotech GTN Summit, Nov 17, 2021 through Nov 19, 2021. Venue: Hilton Penn's Landing Hotel, Philadelphia, Pennsylvania, United States.

Tango Therapeutics, Inc. has closed its Shelf Registration dated September 10, 2021 in the amount of $862.418962 million.

2021-09-29 00:00:00

Tango Therapeutics, Inc. has closed its Shelf Registration dated September 10, 2021 in the amount of $862.418962 million. Security Name: Common Stock Securities Offered: 68,175,412

Gilead Sciences, Inc. Presents at Longwood Healthcare Leaders Conference, Oct-05-2021 03:20 PM

2021-09-28 18:44:00

Gilead Sciences, Inc. Presents at Longwood Healthcare Leaders Conference, Oct-05-2021 03:20 PM. Speakers: Merdad V. Parsey, Chief Medical Officer.

Longwood Fund, Longwood Healthcare Leaders Conference, Oct 04, 2021 through Oct 05, 2021

2021-09-28 13:09:00

Longwood Fund, Longwood Healthcare Leaders Conference, Oct 04, 2021 through Oct 05, 2021.

Gilead Announces Fifth Approval for Trodelvy in Metastatic Triple-Negative Breast Cancer Under Project Orbis Initiative with Health Canada Authorization

2021-09-27 20:35:00

Gilead Sciences, Inc. that Health Canada has approved Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior therapies, at least one of them for metastatic disease. Canada joins Australia, Great Britain, Switzerland, and the United States among the countries that have approved Trodelvy for use under Project Orbis. Project Orbis is an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) with international regulatory authorities as a global collaborative review program for high impact oncology marketing applications across participating countries. Trodelvy is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2, a protein located on the surface of cells, is overexpressed in TNBC as well as other solid tumors. Beyond the Project Orbis regulatory approvals, the European Medicines Agency validated a Marketing Authorization Application for Trodelvy in March and regulatory review is also underway in Kazakhstan and Saudi Arabia, as well as Singapore via licensing partner, Everest Medicines.

Gilead Sciences, Inc. Presents at World Antiviral Congress 2021, Dec-02-2021 11:40 AM

2021-09-24 19:02:00

Gilead Sciences, Inc. Presents at World Antiviral Congress 2021, Dec-02-2021 11:40 AM. Venue: San Diego, California, United States. Speakers: Jared Baeten, Vice President, HIV Clinical Development.

Terrapinn Inc, World Antiviral Congress 2021, Nov 30, 2021 through Dec 02, 2021

2021-09-23 19:35:00

Terrapinn Inc, World Antiviral Congress 2021, Nov 30, 2021 through Dec 02, 2021. Venue: San Diego, California, United States.

Gilead Sciences, Inc. Announces Positive Results from A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial

2021-09-22 13:01:00

Gilead Sciences, Inc. announced positive results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury® (remdesivir) for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. This late-breaking data will be presented at the IDWeek 2021 virtual conference. In an analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. Results also showed an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by Day 28 for participants treated with Veklury (1.6% [4/246]) compared with placebo (8.3% [21/252]) p=0.002. In the study, no deaths were observed in either arm by Day 28. Enrollment for this trial was stopped prior to fulfilling enrollment targets in April 2021, reflecting the changing epidemiology and adoption of additional treatment options at the time; however, the study continued to collect data on enrolled participants and both investigators and participants remained blinded to their assignment of Veklury or placebo. These results complement positive results from ACTT-1 and other studies in hospitalized patients in which Veklury helped patients recover significantly faster and reduced the likelihood of disease progression. The use of Veklury for the treatment of non-hospitalized patients with three days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency globally. In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury. The safety profile was similar between Veklury and placebo in this trial, with the most common treatment emergent adverse events (=5%) in patients taking Veklury being nausea and headache. Of the 279 participants who received Veklury, no new safety signals were identified. One death was observed in the study at Day 59 (participant on placebo); no deaths occurred in either arm of the study by the Day 28 primary endpoint. Gilead is in the process of sharing the data with regulatory agencies. Gilead continues to study the efficacy and safety of Veklury in hospitalized patient populations with ongoing unmet needs, such as patients with renal impairment, children and pregnant women, as well as through the support of a number of externally sponsored trials. Gilead is also developing novel oral treatment options for non-hospitalized patients with COVID-19 and hopes to file investigational new drug applications (IND) with the Food and Drug Administration (FDA) by early next year.

Gilead to Present Latest Antiviral Research Data Addressing Urgent Global Needs in Infectious Disease at IDWeek 2021

2021-09-20 12:30:00

Gilead Sciences, Inc. announced the upcoming presentation of new data from the company’s virology research and development programs at the virtual IDWeek 2021 conference, taking place September 29 – October 3. The findings in COVID-19 research, HIV treatment research and HIV prevention research are the latest example of Gilead’s ongoing commitment to help address the evolving COVID-19 pandemic and the needs of people affected by HIV. COVID-19 Research: At IDWeek 2021, Gilead will present real-world analyses of Veklury, the antiviral standard of care for the treatment of hospitalized patients with COVID-19, to help inform real-time decision-making of clinicians and frontline healthcare workers. These data include a comparative retrospective analysis evaluating the impact of Veklury on mortality rates across the spectrum of baseline oxygen requirements. A second analysis, drawing on data from a large cohort study of U.S. hospitals, looks at the association of patients treated with Veklury and 30-day readmission rates. Further late-breaking data on Veklury in COVID-19 will also be presented at IDWeek. HIV Research: HIV treatment research data at IDWeek include long-term results from the BRAAVE 2020 study evaluating the safety and efficacy of switching to the once-daily, single tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virally suppressed Black or African American adults with pre-existing resistance, viral blips and suboptimal adherence. Data from the ongoing BRAAVE 2020 study could help inform the design of future research programs in Black adults, who continue to be underrepresented in HIV clinical research despite being disproportionately affected by the epidemic. As part of the company’s HIV prevention research program, Gilead will present long-term outcomes from an open-label extension phase of the DISCOVER trial, which is an ongoing, randomized, double-blind, multicenter, active-controlled, phase 3, non-inferiority clinical trial evaluating the efficacy and safety of Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) for PrEP (pre-exposure prophylaxis). Additional HIV prevention research includes insights into improving the recruitment of historically underrepresented individuals for the PURPOSE 2 trial of the company’s investigational, long-acting HIV-1 capsid inhibitor, lenacapavir for PrEP – specifically, optimizing enrolment of Black and Hispanic or Latinx gay and other men who have sex with men, transgender women, transgender men and gender nonbinary individuals. Additionally, to further inform HIV treatment strategies across a broad range of people and communities affected by HIV, Gilead will present results from an in vitro study evaluating the concept of regimen forgiveness with integrase strand transfer inhibitor (INSTI)-based regimens at drug concentrations simulating variable adherence. Gilead will also present a clinical study evaluating methods for measuring adherence in people taking antiretroviral therapy.

American Association For The Study Of Liver Diseases, AASLD the Liver Meeting, Nov 12, 2021 through Nov 15, 2021

2021-09-20 00:00:00

American Association For The Study Of Liver Diseases, AASLD The Liver Meeting, Nov 12, 2021 through Nov 15, 2021.

Gritstone bio, Inc. announced that it has received $55 million in funding from Frazier Management, L.L.C., Gilead Sciences, Inc., Redmile Group, LLC, Lighthouse Investment Partners, LLC and other investors

2021-09-17 00:00:00

On September 17, 2021, Gritstone bio, Inc. closed the transaction. The company received funding from 10 investors pursuant to exemption provided under Regulation D.

Gilead Sciences, Inc Announces New Data Demonstrate Trodelvy Survival Benefit in Metastatic Triple-Negative Breast Cancer Patients Regardless of Initial HR/HER2 Status

2021-09-16 11:00:00

Gilead Sciences, Inc. announced new data from the Phase 3 ASCENT study evaluating Trodelvy® (sacituzumab govitecan-hziy) in patients with relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In a retrospective subgroup analysis, Trodelvy improved progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared with chemotherapy chosen by the patients’ physicians in patients who were not initially diagnosed with TNBC. The results were presented at the European Society of Medical Oncology (ESMO) Congress 2021 from September 16-21, 2021 (Poster #258P). This analysis included 146 chemotherapy-eligible brain metastasis-negative patients with an original breast cancer diagnosis that was not TNBC, of which 70 received Trodelvy and 76 received physician’s choice of chemotherapy. Among these patients, Trodelvy improved median PFS compared with chemotherapy (4.6 months vs. 2.3 months; HR: 0.48; P=0.0004), median OS (12.4 months vs. 6.7 months; HR: 0.44; P<0.0001) and ORR (31% vs. 4%). Outcomes were similar to those of the overall ASCENT trial population. The safety profile of Trodelvy in this subgroup was consistent with prior reports from the ASCENT study. Key treatment-related grade =3 adverse events for Trodelvy compared to chemotherapy were neutropenia (59% vs. 40%), leukopenia (12% vs. 9%), anemia (8% vs. 7%) and diarrhea (7% vs. 0%). There were no treatment-related deaths with Trodelvy. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information. TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer. The ASCENT study is a global, open-label, randomized Phase 3 study that enrolled more than 500 patients across 230 study locations. The study evaluated the efficacy and safety of Trodelvy compared with a single-agent chemotherapy of the physician’s choice in patients with unresectable, locally advanced or metastatic TNBC who had received at least two prior systemic treatments. Patients were randomized to receive either Trodelvy or a chemotherapy chosen by the patients’ treating physicians. The primary endpoint was PFS (as determined by blinded independent central review) in patients without brain metastases. Secondary endpoints included: PFS for full study population or intention-to-treat (ITT) population, OS in both the ITT population and in the subgroup without brain metastasis, independently determined ORR, duration of response, time to onset of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), quality of life and safety.

Gritstone bio, Inc. announced that it expects to receive $55 million in funding from Frazier Management, L.L.C., Gilead Sciences, Inc., Redmile Group, LLC, Lighthouse Investment Partners, LLC and other investors

2021-09-16 00:00:00

Gritstone bio, Inc. announced that it has entered into a securities purchase agreement for a private placement of 5,000,000 shares of par value $0.0001 at a price of $11 per share for gross proceeds of $55,000,000 on September 16, 2021. The transaction will include participation from new investor, Frazier Life Sciences Public Fund, L.P., a fund managed by returning investor, Frazier Management, L.L.C. for 3,636,364 shares, returning investors, Gilead Sciences, Inc. for 454,545 shares, Redmile Capital Fund, LP for 123,565 shares, Redmile Capital Offshore Master Fund, Ltd. for 65,213 shares, Redmile Capital Offshore Fund II, Ltd for 47,188 shares, Redmile Capital Offshore Fund (Erisa), Ltd. for 18,806 shares, Redmile Strategic Master Fund, LP for 557,586 shares, Redmile Capital Offshore II Master Fund, Ltd. (Strategic Sleeve) for 4,534 shares, Redmile Biopharma Investments I for 90,910 shares, funds managed by Redmile Group, LLC and LMA SPC - Map 20 Segregated Portfolio, a fund managed by Lighthouse Investment Partners, LLC for 1,289 shares. The transaction is expected to close on September 17, 2021. The company is issuing securities in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D as promulgated by the United States Securities and Exchange Commission under the Securities Act. The company shall reimburse $25,000 to Frazier Life Sciences Public Fund, L.P. for documented and reasonable consulting, legal and other out of pocket expenses related to the investment and due diligence.

Indegene, Inc., Indegene Digital Summit, Sep 23, 2021 through Sep 24, 2021

2021-09-15 12:30:00

Indegene, Inc., Indegene Digital Summit, Sep 23, 2021 through Sep 24, 2021.

Gilead Sciences, Inc. Presents at Indegene Digital Summit, Sep-23-2021 01:00 PM

2021-09-15 00:00:00

Gilead Sciences, Inc. Presents at Indegene Digital Summit, Sep-23-2021 01:00 PM. Speakers: Cristina Carlis, VP, Global Marketing-Digital & Innovation.

Veeva Systems Inc., 2021 Veeva R&D and Quality Summit Connect, Oct 14, 2021

2021-09-14 11:03:00

Veeva Systems Inc., 2021 Veeva R&D and Quality Summit Connect, Oct 14, 2021.

Tango Therapeutics, Inc. has filed a Shelf Registration in the amount of $1.027403 billion.

2021-09-10 00:00:00

Tango Therapeutics, Inc. has filed a Shelf Registration in the amount of $1.027403 billion. Security Name: Common Stock Securities Offered: 68,175,412

Cambridge Innovation Institute, LLC, SCOPE Summit 2022, Feb 07, 2022 through Feb 10, 2022

2021-09-04 12:00:00

Cambridge Innovation Institute, LLC, SCOPE Summit 2022, Feb 07, 2022 through Feb 10, 2022. Venue: Orlanda, Florida, United States.

Gilead Sciences, Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-15-2021 12:30 PM

2021-09-01 20:05:00

Gilead Sciences, Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-15-2021 12:30 PM. Venue: New Windsor, United States.

Evercore Inc., 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov 29, 2021 through Dec 03, 2021

2021-08-24 20:29:00

Evercore Inc., 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov 29, 2021 through Dec 03, 2021.

Gilead Sciences, Inc. Presents at Digital Pharma East, Sep-28-2021

2021-08-23 07:02:00

Gilead Sciences, Inc. Presents at Digital Pharma East, Sep-28-2021 . Venue: Philadelphia, Pennsylvania, United States. Speakers: Cristina Carlis, Vice President, Digital Innovation.

FiercePharma, Digital Pharma East, Sep 28, 2021 through Sep 30, 2021

2021-08-23 06:18:00

FiercePharma, Digital Pharma East, Sep 28, 2021 through Sep 30, 2021. Venue: Philadelphia, Pennsylvania, United States.

Gilead Sciences, Inc. Announces That the Company’s Marketing Authorization Application for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor, Has Been Fully Validated and Is Under Evaluation with the European Medicines Agency

2021-08-19 20:15:00

Gilead Sciences, Inc. announced that the company’s Marketing Authorization Application for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is under evaluation with the European Medicines Agency. The proposed indication is for the treatment of HIV-1 infection, in combination with other antiretroviral, in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. The application will be reviewed by the EMA’s Committee for Medicinal Products for Human Use under the centralized licensing procedure for all 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. The MAA is supported by data from the ongoing CAPELLA study, which achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive oral lenacapavir in combination with an optimized background regimen (n=24) achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo (n=12) during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). Lenacapavir was generally well-tolerated, with no serious adverse events related to study drug and no study drug discontinuations through the 14-day period, including no discontinuations due to adverse events. The most common adverse events observed were injection site reactions. These data were previously presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021). 26-week data from the CAPELLA study were presented at the 11th International AIDS Society (IAS) Conference on HIV Science. Additional data from the CAPELLA study will be presented at a future scientific conference. In June 2021, Gilead submitted a New Drug Application (NDA) for lenacapavir seeking U.S. Food & Drug Administration (FDA) approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use; its safety and efficacy are not established. There is no cure for HIV or AIDS.

Gilead Sciences, Inc. Presents at World Vaccine & Immunotherapy Congress West Coast 2021, Nov-30-2021 through Dec-02-2021

2021-08-18 15:33:00

Gilead Sciences, Inc. Presents at World Vaccine & Immunotherapy Congress West Coast 2021, Nov-30-2021 through Dec-02-2021. Venue: Loews Coronado Bay Resort, San Diego, California, United States. Presentation Date & Speakers: Dec-02-2021, Jared Baeten, Vice President HIV Clinical Research. Nov-30-2021, Tomas Cihlar, VP, Virology.

Gilead Sciences, Inc. Presents at 5th Annual IPF Summit, Aug-27-2021 03:00 PM

2021-08-10 14:19:00

Gilead Sciences, Inc. Presents at 5th Annual IPF Summit, Aug-27-2021 03:00 PM. Speakers: Ruchi Gupta, Senior Associate Director.

Hanson Wade Limited, 5th Annual IPF Summit, Aug 25, 2021 through Aug 27, 2021

2021-08-10 12:54:00

Hanson Wade Limited, 5th Annual IPF Summit, Aug 25, 2021 through Aug 27, 2021.

Tango Therapeutics, Inc. announced that it has received $186.1 million in funding from a group of investors

2021-08-10 00:00:00

On August 10, 2021, Tango Therapeutics, Inc. closed the transaction.

Dtex Systems, Inc., The Escal Institute Of Advanced Technologies, Inc., 2021 Insider Risk Management Solutions Forum, Sep 01, 2021

2021-08-05 16:00:00

Dtex Systems, Inc., The Escal Institute Of Advanced Technologies, Inc., 2021 Insider Risk Management Solutions Forum, Sep 01, 2021.

Gilead Sciences, Inc. Presents at 2021 Insider Risk Management Solutions Forum, Sep-01-2021

2021-08-05 16:00:00

Gilead Sciences, Inc. Presents at 2021 Insider Risk Management Solutions Forum, Sep-01-2021 .

Gilead Sciences, Inc. Presents at Pharma Europe, Oct-12-2021 10:15 AM

2021-08-05 08:20:00

Gilead Sciences, Inc. Presents at Pharma Europe, Oct-12-2021 10:15 AM. Speakers: Elliot Antrobus-Holder, Global Head, Omnichannel.

Reuters Events, Pharma Europe, Oct 11, 2021 through Oct 22, 2021

2021-08-05 03:58:00

Reuters Events, Pharma Europe, Oct 11, 2021 through Oct 22, 2021.

Gilead Sciences, Inc. Declares Dividend for the Third Quarter of 2021, Payable on September 29, 2021

2021-07-29 20:01:00

Gilead Sciences, Inc. announced that the company’s Board of Directors has declared a quarterly dividend of $0.71 per share of common stock for the third quarter of 2021. The dividend is payable on September 29, 2021, to stockholders of record at the close of business on September 15, 2021.

Gilead Sciences, Inc. Revises Earnings Guidance for the Full Year 2021

2021-07-29 20:01:00

Gilead Sciences, Inc. revised earnings guidance for the full year 2021. For the year, the company expected product sales is expected to be in the range of $24,4000 million and $25,000 million compared to previous guidance of $23,700 million and $25,100 million. GAAP projected operating income is expected to be in the range of $9,200 million to $9,900 million compared with previous guidance of $9,000 million to $10,400 million. GAAP projected diluted EPS is expected to be in the range of $4.70 to $5.05 compared with previous guidance of $4.75 to $5.45.

Tranche Update on Gilead Sciences, Inc. (NasdaqGS:GILD)'s Equity Buyback Plan announced on February 2, 2016.

2021-07-29 00:00:00

From April 1, 2021 to June 30, 2021, the company has repurchased 645,000 shares, representing 0.05% for $43.09 million. With this, the company has completed the repurchase of 142,872,000 shares, representing 11.02% for $10,531.61 million under the buyback announced on February 2, 2016.

Tranche Update on Gilead Sciences, Inc. (NasdaqGS:GILD)'s Equity Buyback Plan announced on February 25, 2020.

2021-07-29 00:00:00

From April 1, 2021 to June 30, 2021, the company has repurchased 0 shares, representing 0% for $0 million. With this, the company has completed the repurchase of 0 shares, representing 0% for $0 million under the buyback announced on February 25, 2020.

Gilead Sciences, Inc., $ 0.71, Cash Dividend, Sep-14-2021

2021-07-26 00:00:00

Gilead Sciences, Inc., $ 0.71, Cash Dividend, Sep-14-2021

Terrapinn Holdings Ltd, World Vaccine & Immunotherapy Congress West Coast 2021, Nov 30, 2021 through Dec 02, 2021

2021-07-22 01:45:00

Terrapinn Holdings Ltd, World Vaccine & Immunotherapy Congress West Coast 2021, Nov 30, 2021 through Dec 02, 2021. Venue: Loews Coronado Bay Resort, San Diego, California, United States.

Gilead Sciences, Inc Announces New Results from the Ongoing Phase 2/3 CAPELLA Trial Evaluating Lenacapavir

2021-07-17 10:01:00

Gilead Sciences, Inc. announced new results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir, the company’s investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV. The findings demonstrate that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression at Week 26 in people living with HIV whose virus was no longer effectively responding to therapy. In this patient population of high unmet medical need, 81% (n=29/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at Week 26. The data were presented at the 11th International AIDS Society (IAS) Conference on HIV Science. These data support the ongoing evaluation of lenacapavir for the treatment of HIV-1 infection and form the basis of the New Drug Application (NDA) that the company recently submitted seeking U.S. Food & Drug Administration (FDA) approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals. If approved, lenacapavir would be the first capsid inhibitor and the only HIV-1 treatment option administered every six months. Lenacapavir is being developed in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with multi-drug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. Lenacapavir is a potentially first-in-class capsid inhibitor without overlapping resistance with any currently approved antiretroviral therapy (ART). Lenacapavir is designed to inhibit HIV replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated uptake of HIV-1 proviral DNA, virus assembly and release, and capsid core formation. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. Lenacapavir is being developed in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with multi-drug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. Lenacapavir is a potentially first-in-class capsid inhibitor without overlapping resistance with any currently approved antiretroviral therapy (ART). Lenacapavir is designed to inhibit HIV replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated uptake of HIV-1 proviral DNA, virus assembly and release, and capsid core formation. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. In addition to 81% of CAPELLA participants achieving an undetectable viral load at Week 26, participants achieved a mean increase in CD4 count of 81 cells/µL. In the data presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021), the CAPELLA trial achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive lenacapavir (n=24) achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo (n=12) during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). Those who received lenacapavir achieved a statistically significantly greater mean decrease in viral load than those who received placebo during the functional monotherapy period (-1.93 log10 copies/mL vs. -0.29 log10 copies/mL, p<0.0001). Lenacapavir was generally well tolerated, with no adverse events (AEs) leading to study drug discontinuation and no serious adverse events related to lenacapavir. The most common adverse events observed to date in the CAPELLA study were injection site reactions, which were mostly mild in severity. The most common injection site reactions were injection site swelling (26%) and erythema (24%). Four participants experienced treatment-emergent lenacapavir resistance and three of these four participants later re-suppressed while continuing lenacapavir in addition to their optimized background regimen. One participant did not re-suppress. Gilead presented additional lenacapavir clinical development program data at the conference. Phase 2 data from CALIBRATE, an ongoing, open-label, active-controlled trial in treatment-naïve people with HIV-1 infection showed lenacapavir, given subcutaneously or orally, in combination with oral daily emtricitabine/tenofovir alafenamide (F/TAF) led to high rates of viral suppression by Week 28 (94%; n=147/157). Specifically, in the pooled subcutaneous lenacapavir + F/TAF arms, 93% (n=98/105) achieved an undetectable viral load (<50 copies/mL). In the oral lenacapavir + F/TAF arm, 94% (n=49/52) achieved an undetectable viral load (<50 copies/mL). These results support the ongoing evaluation and further development of lenacapavir in combination with other long-acting partner agents for the treatment of HIV-1 infection and will support Gilead’s long-acting oral and injectable development program.

Gilead Sciences, Inc Announces Four-Year Biktarvy® Data Presented At Ias 2021 Demonstrate High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults

2021-07-17 10:01:00

Gilead Sciences, Inc. announced a pooled analysis of a 48-week open-label extension of two Phase 3 studies (Study 1489 and Study 1490) shows 99% of participants who initiated treatment with Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) through four years of follow-up (Week 192, n=476/480, missing=excluded). In the 48-week open-label extension, there were zero cases of treatment-emergent resistance to any components of Biktarvy in participants treated with Biktarvy. These findings, along with long-term data from Phase 3 studies in virologically suppressed Black Americans and virologically suppressed people living with HIV aged 65 and older, demonstrated Biktarvy sustains efficacy with a high barrier to resistance across a range of people living with HIV, inclusive of their treatment history, gender, race or age. These data were presented at the 11th International AIDS Society (IAS) Conference on HIV Science. Gilead presented additional Biktarvy data at IAS 2021, including findings from the BRAAVE 2020 Study, a Phase 3 clinical trial designed with community input to evaluate the specific treatment responses of virologically suppressed adults living with HIV who self-identified as Black or African American following a switch to Biktarvy from a variety of regimens. A total of 495 study participants were randomly allocated and treated in a 2:1 ratio to either switch to open-label Biktarvy for up to 72 weeks (n=330) or to stay on a standard regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent for 24 weeks with a delayed switch to Biktarvy for up to 48 weeks (n=165). At 72 weeks, 99% of participants (n=246/248, missing=excluded) who switched to Biktarvy at the start of the study maintained an undetectable viral load regardless of age or sex at birth. These results provide further evidence that Biktarvy is an effective and durable treatment option for Black adults who are virologically suppressed, including those with a history of treatment failure or pre-existing resistance. Gilead also presented long-term data from a Phase 3b open-label trial enrolling people living with HIV aged 65 and older who switched to Biktarvy (n=86) from either Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) or a tenofovir disoproxil fumarate (TDF)-based regimen. The analysis showed that 100% of participants (n=68/68, missing=excluded) and 74% of participants (n=64/86) in the snapshot analysis of the Intention to Treat-Exposed (ITT-E) population having HIV-1 RNA <50 copies/mL maintained high rates of virologic suppression at Week 96 with no virologic failures or emergent resistance through 96 weeks. The COVID-19 pandemic impacted in-person visits during the study, with 11 participants unable to be assessed after 84 weeks due to restrictions. There were two participants (2.3%) with Grade 3-4 study drug-related AEs, 11 participants (13%) with Grade 3-4 laboratory abnormalities and three participants (3.5%) with drug-related adverse events (AEs) leading to study drug discontinuation. These results reinforce Biktarvy as an effective and generally well-tolerated treatment option with a high barrier to resistance in the growing population of older people living with HIV. Results from a Phase 3 study (Study 1844) demonstrated the safety and non-inferior efficacy of switching to Biktarvy in those replacing their existing treatment regimen. In Study 1844, participants (n=563) who were virologically suppressed (HIV-1 RNA <50 copies/mL) on a regimen containing abacavir, dolutegravir, and lamivudine (600/50/300mg) (ABC/DTG/3TC) were randomly allocated and treated in a 1:1 ratio to stay on their existing regimen of ABC/DTG/3TC (n=281) or switch to Biktarvy (n=282) in a blinded manner. The primary endpoint was the proportion of patients with HIV RNA =50 copies/mL at Week 48. Study participants were randomly allocated through 48 weeks, after which point participants electing to continue in the study enter an open-label extension receiving Biktarvy. At the point of the last study visit, 98% (n=535/545) of those who switched to Biktarvy maintained virologic suppression for a median duration of two years, including those with pre-existing resistance or who experienced viral “blips.” In participants treated with Biktarvy, there were no cases of treatment failure with resistance to any component of Biktarvy. Study 1489 and Study 1490 are Phase 3, double-blind, active-controlled studies. For 144 weeks, treatment-naïve participants were blinded to receive either Biktarvy (n=634) or a dolutegravir-containing triple therapy (n=640). Treatment outcomes were assessed at Week 144 and showed participants in both groups achieved an undetectable viral load with no treatment-emergent resistance. Beyond Week 144, participants were able to receive Biktarvy in an active OLE Phase for up to 96 weeks. Study 1489 and Study 1490 are ongoing.

Gilead Sciences, Inc. to Report Q2, 2021 Results on Jul 29, 2021

2021-07-15 20:05:00

Gilead Sciences, Inc. announced that they will report Q2, 2021 results After-Market on Jul 29, 2021

Gilead Sciences, Inc., Q2 2021 Earnings Call, Jul 29, 2021

2021-07-15 20:05:00

Gilead Sciences, Inc., Q2 2021 Earnings Call, Jul 29, 2021

Gilead Sciences, Inc. Presents at Cell-Mediated Therapies for Infectious Disease Summit, Jul-21-2021 10:00 AM

2021-07-06 15:48:00

Gilead Sciences, Inc. Presents at Cell-Mediated Therapies for Infectious Disease Summit, Jul-21-2021 10:00 AM. Speakers: Wade Blair, Executive Director, Biology.

Hanson Wade Limited, Cell-Mediated Therapies for Infectious Disease Summit, Jul 21, 2021 through Jul 22, 2021

2021-07-06 13:00:00

Hanson Wade Limited, Cell-Mediated Therapies for Infectious Disease Summit, Jul 21, 2021 through Jul 22, 2021.

Biotechnology Innovation Organization, BIO IP Counsels Committee Webinar Series – Episode 3, Jul 28, 2021

2021-07-02 08:55:00

Biotechnology Innovation Organization, BIO IP Counsels Committee Webinar Series – Episode 3, Jul 28, 2021.

Gilead Sciences, Inc. Presents at BIO IP Counsels Committee Webinar Series – Episode 3, Jul-28-2021 01:00 PM

2021-07-02 08:55:00

Gilead Sciences, Inc. Presents at BIO IP Counsels Committee Webinar Series – Episode 3, Jul-28-2021 01:00 PM. Speakers: Tashica Amirgholizadeh, ASSOCIATE GENERAL COUNSEL, INTELLECTUAL PROPERTY.

Pardes Biosciences, Inc. announced that it expects to receive $75 million in funding from a group of investors

2021-06-29 00:00:00

Pardes Biosciences, Inc. announced that it has entered into subscription agreements with certain investors for private placement of 7,500,000 class A common shares at a price of $10 per share for gross proceeds of $75,000,000 on June 29, 2021. The transaction included participation from a group of premier institutional and strategic healthcare investors led by existing investors Foresite Capital Management, LLC, GMF Capital LLC, new investors EcoR1 Capital, LLC, Monashee Investment Management LLC, RA Capital Management, L.P., funds and accounts advised by T. Rowe Price Associates, Inc., Frazier Life Sciences along with Gilead Sciences, Inc. The shares are subject to lockup period of 180 days from closing of transaction. The transaction is subject to satisfaction or waiver of certain other customary closing conditions, which is expected to be completed by October 2021. The transaction has been approved by the board of directors of the company. The shares will be issued pursuant to exemption provided by Section 4(a)(2) of the Securities Act of 1933, as amended.