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FDA Approves Eli Lilly and Company and Incyte's OLUMIANT® (baricitinib) as First and Only Systemic Medicine for Adults with Severe Alopecia Areata

2022-06-14 01:50:00

Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.1 The recommended dose is OLUMIANT 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day. Once an adequate response is achieved on 4-mg/day, the dosage is to be decreased to 2-mg/day. OLUMIANT is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. The approval was based on Lilly's BRAVE-AA1 and BRAVE-AA2 trials, the largest Phase 3 AA clinical trial program completed to date, evaluating the efficacy and safety of OLUMIANT in 1,200 adult patients with severe AA (=50% scalp hair loss as defined by a Severity of Alopecia Tool (SALT) score =50). Across the studies at 36 weeks, 17-22% of patients taking OLUMIANT 2-mg/day and 32-35% of patients taking OLUMIANT 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo. Additionally, 11-13% of patients taking OLUMIANT 2-mg/day and 24-26% of patients taking OLUMIANT 4-mg/day achieved 90% or more hair coverage, compared to 1-4% of patients taking placebo; results for OLUMIANT 2-mg/day were not statistically significant under the multiplicity control plan for BRAVE-AA2. Among patients with substantial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking OLUMIANT 4-mg daily at 36 weeks.  The BRAVE-AA clinical program evaluated the safety profile of OLUMIANT. Few patients discontinued treatment due to adverse events (average of 2.2% across both studies) in the 36-week placebo-controlled period and the majority of treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse reactions (=1%) were upper respiratory tract infections, headache, acne, high cholesterol levels, increases in blood markers related to the muscle, urinary tract infections, elevated liver enzyme levels, inflammation of hair follicles, fatigue, lower respiratory tract infections, nausea, genital yeast infection, low red blood cell counts, low white blood cell counts, abdominal pain, shingles and weight increase. The U.S. FDA-approved labeling for OLUMIANT includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis. Lilly is committed to ensuring patients have access to much-needed medicines and is working with insurers to do so. Through the OLUMIANT TogetherTM support program, Lilly offers a savings card for eligible commercially insured patients to help with out-of-pocket costs where they pay as little as $5/month if covered by their insurance provider or $25 per month if not covered by their plan.

Pfizer, Morphosys and Incyte Enter into Clinical Trial Collaboration for Monjuvi (Tafasitamab-Cxix) in Combination with TTI-622, A Fusion Protein Directed Against CD47

2022-06-13 20:01:00

Pfizer Inc., MorphoSys U.S. Inc., and Incyte announced a clinical trial collaboration and supply agreement to investigate the immunotherapeutic combination of Pfizer's TTI-622, a novel SIRPa-Fc fusion protein, and Monjuvi (tafasitamab-cxix) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). Pfizer's TTI-622 is currently in Phase 1b/2 development across several indications, with a focus on hematological malignancies. CD47 is an innate immune checkpoint that binds SIRP? and delivers a "don't eat me" signal to suppress macrophage phagocytosis. Overexpression of CD47 in solid and hematological malignancies, including in DLBCL, is associated with poor prognosis.Monjuvi (marketed ex-U.S. as Minjuvi), a CD19-directed immunotherapy, in combination with lenalidomide is a treatment for adult patients with relapsed or refractory DLBCL not otherwise specified, and who are not eligible for ASCT. In this indication, accelerated or conditional approvals were granted by the U.S. Food and Drug Administration, the European Medicines Agency and other regulatory authorities. Monjuvi is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States. Preclinical data by Morphosys have shown a strong synergy of Monjuvi and anti-CD47 antibodies in vitro and in vivo lymphoma models, providing scientific rationale for investigating this combination in clinical trials. This preclinical data was presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition in 2020. Under the terms of the agreement, Pfizer will initiate a multicenter, international Phase 1b/2 study of TTI-622 with Monjuvi and lenalidomide for patients with relapsed or refractory DLBCL who are not eligible for ASCT. MorphoSys and Incyte will provide Monjuvi for the study, which will be sponsored and funded by Pfizer and is planned to be conducted in North America, Europe and Asia-Pacific. The collaboration is effective immediately upon the execution of the agreement.

Incyte Corporation Presents at European Hematology Association 2022 Annual Congress, Jun-10-2022 11:30 AM

2022-05-26 10:00:00

Incyte Corporation Presents at European Hematology Association 2022 Annual Congress, Jun-10-2022 11:30 AM. Venue: Vienna, Austria.

Incyte Corporation Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-14-2022 08:00 AM

2022-05-24 12:00:00

Incyte Corporation Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-14-2022 08:00 AM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

Chmp Recommends Approval of Eli Lilly and Company and Incyte's Olumiant® (Baricitinib) as the First and Only Centrally-Authorized Treatment for Adults with Severe Alopecia Areata (Aa)

2022-05-20 12:11:00

Eli Lilly and Company and Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for OLUMIANT® (baricitinib) for the treatment of adults with severe alopecia areata (AA). This opinion marks the first step toward European regulatory approval of OLUMIANT for patients with severe AA, and it is now referred to the European Commission for final action. If approved, OLUMIANT would be the first centrally-authorized oral treatment and first JAK inhibitor for patients with severe AA in the European Union. The European Commission's decision is expected in the next one to two months. The positive opinion was based on Lilly's Phase 3 BRAVE-AA1 and BRAVE-AA2 trials evaluating the efficacy and safety of OLUMIANT in 1,200 patients with severe AA, the largest Phase 3 clinical trial program with completed primary endpoints. Severe AA was defined as having a Severity of Alopecia Tool (SALT) score =50 (=50% scalp hair loss). The primary endpoint was the proportion of patients achieving SALT =20 (i.e., 80% or more scalp hair coverage) at Week 36. Across both studies, 1 out of 3 patients treated with OLUMIANT 4-mg acchieved 80% or more scalp hair coverage (BRAVE-AA1=35.2% [n=99]; BRAVE-AA2=32.5% [n=76]), compared to 1 out of 20 patients (5.3%, n=10) and 1 out of 50 patients (2.6%, n=4) taking placebo in BRAVE-AA1 and BRAVE-AA2, respectively (p=0.001 for all comparisons to placebo). Achievement of full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair was also seen at 36 weeks with OLUMIANT 4-mg for 1 in 3 patients who at baseline had significant gaps or no notable eyebrows or eyelashes, as compared to patients taking placebo (BRAVE-AA1: 4-mg dose: eyebrow=31.4% [n=59]; eyelash=33.5% [n=56]; placebo: eyebrow=3.2% [n=4]; eyelash=3.1% [n=3]; BRAVE-AA2: 4-mg dose: eyebrow=34.8% [n=56]; eyelash=34.3% [n=48]; placebo: eyebrow=4.5% [n=5]; eyelash=5.6% [n=5]; p=0.001 for all comparisons to placebo). Eyebrow and eyelash hair loss was evaluated using the Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss™ and ClinRO Measure for Eyelash Hair Loss™ – novel, clinically-validated tools developed by Lilly. The Phase 3 BRAVE-AA clinical program also evaluated the safety profile of OLUMIANT, and no new safety signals were observed. Few patients discontinued treatment due to adverse events (2.6% or less across both studies), and the majority of treatment-emergent adverse events were mild or moderate in severity.

FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19

2022-05-11 10:45:00

Eli Lilly and Company and Incyte announced the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) with a recommended dose of 4-mg once daily for 14 days or until hospital discharge, whichever comes first. The FDA's approval is supported by results from two randomized, double-blind, placebo-controlled Phase 3 studies (ACTT-2 and COV-BARRIER, including the COV-BARRIER OS 7 addendum study), announced previously. No new safety signals potentially related to the use of OLUMIANT were identified in the studies. Baricitinib has been available in the U.S. under Emergency Use Authorization (EUA) since November 2020. An EUA will remain in place for hospitalized pediatric patients 2 to less than 18 years old who require various degrees of oxygen support. The emergency authorization is not an approval and is temporary for the duration where circumstances justify the authorization. For additional information about the authorized use, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers. Lilly has submitted applications for regulatory approval or authorization to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow. The U.S. FDA-approved labeling for OLUMIANT carries a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis. Patients treated with OLUMIANT are at an increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis. Higher rates of all-cause mortality and MACE have been observed with another JAK inhibitor versus tumor necrosis factor (TNF) blockers. Malignancies and thrombosis have occurred in patients treated with OLUMIANT and higher rates of each have been observed with another JAK inhibitor versus TNF blockers. Consider the risks and benefits of treatment prior to initiating or continuing therapy with OLUMIANT. OLUMIANT is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. OLUMIANT is available in the U.S. as 1-mg and 2-mg tablets through Lilly's authorized specialty distributors. About ACTT-2 (COVID I) Study:- ACTT-2 was a randomized, double-blind, placebo-controlled clinical trial of certain hospitalized adults with confirmed SARS-CoV-2 infection that compared treatment with OLUMIANT and remdesivir (combination group; n=515) to treatment with placebo and remdesivir (placebo group; n=518). Patients treated with the combination received OLUMIANT 4-mg once daily (orally) for 14 days or until hospital discharge, whichever was first, and remdesivir 200-mg on Day 1 and 100-mg once-daily (via intravenous infusion) on subsequent days for a total treatment duration of 10 days or until hospital discharge, whichever was first. The primary endpoint, for the intent to treat population, was time to recovery within 29 days after randomization. Recovery was defined as being discharged from the hospital without limitations on activities, being discharged from the hospital with limitations on activities and/or requiring home oxygen, or hospitalized but not requiring supplemental oxygen and no longer requiring medical care. The key secondary endpoint was clinical status on Day 15, as assessed on an 8-point ordinal scale.

The European Hematology Association, European Hematology Association 2022 Annual Congress, Jun 09, 2022 through Jun 17, 2022

2022-05-10 11:00:00

The European Hematology Association, European Hematology Association 2022 Annual Congress, Jun 09, 2022 through Jun 17, 2022. Venue: Vienna, Austria.

Incyte Announces European Commission Approval of Jakavi (Ruxolitinib) as the First Post-Steroid Treatment for Acute and Chronic Graft-Versus-Host Disease

2022-05-05 05:20:00

Incyte announced the European Commission (EC) has approved Jakavi® (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GVHD who have inadequate response to corticosteroids or other systemic therapies. Ruxolitinib is marketed as Jakavi by Novartis in Europe and as Jakafi by Incyte in the United States. The approval of Jakavi follows the positive opinion granted in March 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on the Phase 3 REACH2 and REACH3 clinical studies in which Jakavi demonstrated superiority in overall response rate (ORR) compared to best available therapy (BAT). Results of REACH2 showed 62% ORR with Jakavi at Day 28, compared to 39% for BAT; and REACH3 demonstrated a significantly improved ORR at week 24 (50% vs. 26%) with a higher best ORR (76% vs. 60%) vs. BAT, among steroid-refractory/dependent chronic GVHD patients. GVHD occurs when donor cells see the recipient’s healthy cells as foreign and attack them. Symptoms of GVHD can appear in the skin, gastrointestinal tract, liver, mouth, eyes, genitals, lungs and joints. Approximately 50% of allogeneic stem cell transplant recipients will develop either acute or chronic GVHD. Both acute and chronic GVHD can be fatal and until now both have lacked an established standard of care for patients who do not adequately respond to first-line steroid treatment. Currently, there are no other approved therapies for the treatment of GVHD after steroid failures in Europe.

Incyte Corporation Presents at RBC Capital Markets Global Healthcare Conference, May-17-2022 10:30 AM

2022-05-04 20:15:00

Incyte Corporation Presents at RBC Capital Markets Global Healthcare Conference, May-17-2022 10:30 AM. Venue: InterContinental New York, Barclay hotel, New York, New York, United States.

Incyte Corporation Reaffirms Revenue Guidance for the Full Year 2022

2022-05-03 11:16:00

Incyte Corporation reaffirmed revenue guidance for the full year 2022. For the year, the company's Jakafi net product revenues to be in the range of $2.33 billion - $2.4 billion and other Hematology/Oncology net product revenues to be in the range of $210 million - $240 million.

Incyte Corporation, Annual General Meeting, Jun 15, 2022

2022-04-29 12:01:00

Incyte Corporation, Annual General Meeting, Jun 15, 2022, at 13:00 Eastern Daylight. Location: Incyte Corporation, 1815 Augustine Cut-Off Wilmington Delaware United States Agenda: To elect eight directors to serve until the 2023 Annual Meeting of Stockholders and thereafter until their successors are duly elected and qualified; to approve, on a non-binding, advisory basis, the compensation of the Company’s named executive officers; to ratify the appointment of Ernst & Young LLP as the Company’s independent registered public accounting firm for 2022; and to transact such other business as may properly come before the Annual Meeting of Stockholders and any postponement or adjournment of the Annual Meeting.

Incyte Corporation and Maruho Announce Strategic Alliance Agreement for Ruxolitinib Cream in Japan

2022-04-28 20:05:00

Incyte Corporation and Maruho Co. Ltd. announced that the companies have entered into a Strategic Alliance Agreement for the development, manufacturing and exclusive commercialization of ruxolitinib cream, a novel cream formulation of Incyte’s selective JAK2 inhibitor ruxolitinib, for treatment of autoimmune and inflammatory dermatology indications in Japan. Under the terms of the agreement, Maruho will make an upfront payment to Incyte and Incyte is eligible to receive additional potential development, regulatory and commercial milestones and royalties on net sales of the licensed product in Japan. Maruho will receive the rights to develop, manufacture and exclusively commercialize ruxolitinib cream, and other potential future topical formulations of ruxolitinib, in autoimmune and inflammatory dermatologic diseases, including vitiligo and atopic dermatitis, in Japan.

Incyte Corporation Presents at PEGS Boston Conference 2022, May-02-2022 through May-06-2022

2022-04-23 07:37:00

Incyte Corporation Presents at PEGS Boston Conference 2022, May-02-2022 through May-06-2022. Venue: Boston, Massachusetts, United States. Presentation Date & Speakers: May-02-2022, Horacio G. Nastri, Associate Vice President, Biotherapeutics. May-03-2022, Horacio Nastri, Associate Vice President, Biotherapeutics. May-04-2022, Horacio G. Nastri, Associate Vice President, Biotherapeutics.

Incyte Announces Positive Committee for Medicinal Products Opinion for Capmatinib (Tabrecta®) for the Treatment of Metex14 Advanced Non-Small Cell Lung Cancer

2022-04-22 13:40:00

Incyte announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency’s has issued a positive opinion that recommends granting marketing authorization for capmatinib (Tabrecta®) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harboring alterations leading to mesenchymalepithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. The CHMP opinion is based on data the Phase 2 GEOMETRY mono-1 study that demonstrated positive overall response rates (ORR) among adult patients with advanced NSCLC whose tumors have alterations leading to METex14 skipping. Based on data presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, in the 31 patients who received Tabrecta as second-line therapy in the METex14 skipping pretreated population, a confirmed ORR of 51.6% (95% CI, 33.1-69.8)was achieved, and the ORR across all 100 previously-treated patients, which included patients who received one or two prior lines of systemic therapy, was 44.0% (95% CI, 34.1-54.3)1. The most common treatment-related adverse events (AEs) (incidence =20%) were peripheral oedema, nausea, fatigue, vomiting, dyspnea, decreased appetite and back pain. In the European Union, there are an estimated 291,000 patients with locally advanced or metastatic NSCLC4. METex14 skipping, a recognized oncogenic driver, occurs in approximately 3-4% of NSCLC cases. Novartis has exclusive worldwide development and commercialization rights to Tabrecta. Incyte is eligible for a total of over $500 million in milestones as well as royalties of between 12-14% on global net sales by Novartis.

Incyte Corporation, Q1 2022 Earnings Call, May 03, 2022

2022-04-12 12:00:00

Incyte Corporation, Q1 2022 Earnings Call, May 03, 2022

Incyte Corporation to Report Q1, 2022 Results on May 03, 2022

2022-04-12 12:00:00

Incyte Corporation announced that they will report Q1, 2022 results at 7:00 AM, US Eastern Standard Time on May 03, 2022

RBC Capital Markets, LLC, RBC Capital Markets Global Healthcare Conference, May 17, 2022 through May 18, 2022

2022-03-04 01:06:00

RBC Capital Markets, LLC, RBC Capital Markets Global Healthcare Conference, May 17, 2022 through May 18, 2022. Venue: InterContinental New York, Barclay hotel, New York, New York, United States.

Incyte Corporation Provides Revenue Guidance for the Full Year 2022

2022-02-08 12:18:00

Incyte Corporation provided revenue guidance for the full year 2022. For the year, the company's Jakafi net product revenues to be in the range of $2.3 billion - $2.4 billion and other Hematology/Oncology net product revenues to be in the range of $210 million - $240 million.

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.

Incyte Corporation has filed a Shelf Registration in the amount of $2.452313 billion.

2022-02-08 00:00:00

Incyte Corporation has filed a Shelf Registration in the amount of $2.452313 billion. Security Name: Common Stock Securities Offered: 33,433,028

Incyte Corporation Presents at SLAS 2022 International Conference and Exhibition, Feb-09-2022 10:00 AM

2022-02-05 10:28:00

Incyte Corporation Presents at SLAS 2022 International Conference and Exhibition, Feb-09-2022 10:00 AM. Venue: Boston Convention and Exhibition Center, Boston, Massachusetts, United States. Speakers: Alejandro Amador Arjona.

Incyte Corporation Presents at SCOPE Summit 2022, Feb-09-2022 03:50 PM

2022-02-03 10:27:00

Incyte Corporation Presents at SCOPE Summit 2022, Feb-09-2022 03:50 PM. Venue: Orlanda, Florida, United States. Speakers: Jennifer Heckman, Executive Director, Clinical Portfolio & Capacity Management.

Incyte Corporation, Q4 2021 Earnings Call, Feb 08, 2022

2022-01-18 13:00:00

Incyte Corporation, Q4 2021 Earnings Call, Feb 08, 2022

Incyte Corporation to Report Q4, 2021 Results on Feb 08, 2022

2022-01-18 13:00:00

Incyte Corporation announced that they will report Q4, 2021 results at 7:00 AM, US Eastern Standard Time on Feb 08, 2022

Cambridge Innovation Institute, LLC, PEGS Boston Conference 2022, May 02, 2022 through May 06, 2022

2022-01-13 18:45:00

Cambridge Innovation Institute, LLC, PEGS Boston Conference 2022, May 02, 2022 through May 06, 2022. Venue: Boston, Massachusetts, United States.

Society for Laboratory Automation & Screening, SLAS 2022 International Conference and Exhibition, Feb 05, 2022 through Feb 09, 2022

2021-12-28 18:17:00

Society for Laboratory Automation & Screening, SLAS 2022 International Conference and Exhibition, Feb 05, 2022 through Feb 09, 2022. Venue: Boston Convention and Exhibition Center, Boston, Massachusetts, United States.

Incyte Corporation(NasdaqGS:INCY) dropped from NASDAQ-100 Index

2021-12-17 00:00:00

Incyte Corporation has been removed from NASDAQ-100 Index.

Incyte Announces Acceptance and Priority Review of SNDA for Ruxolitinib Cream (Opzelura) as a Treatment for Patients with Vitiligo

2021-12-14 21:30:00

Incyte announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5% (Opzelura) a topical JAK inhibitor, as a potential treatment for adolescents and adults (age =12 years) with vitiligo. The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. The Prescription Drug User Fee Act (PDUFA) target action date is April 18, 2022. The sNDA is supported by data from the Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream in more than 600 people with non-segmental vitiligo, age 12 and older. Results from the Phase 3 program were recently presented at the 30th European Academy of Dermatology and Venereology (EADV) congress during a late-breaking research session. The data showed that at Week 24, 29.9% of patients applying ruxolitinib cream achieved =75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint. In September 2021, Opzelura™ (ruxolitinib) cream was approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura™ in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

MorphoSys and Incyte Announce Additional Real-World Evidence Results from RE-MIND2 Study of Tafasitamab (Monjuvi®) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

2021-12-11 17:00:00

MorphoSys US Inc. and Incyte announced additional real-world evidence results from the RE-MIND2 study comparing tafasitamab (Monjuvi®) in combination with lenalidomide against the most frequently used treatments in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). These treatments include polatuzumab vedotin plus bendamustine and rituximab (Pola-BR), rituximab plus lenalidomide (R2), and CD19 chimeric antigen receptor T-cell (CAR-T) therapies. The data, which builds on the primary analysis presented at the 2021 Annual Meeting of the Society of Hematologic Oncology (SOHO 2021), will be presented as an oral presentation at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held December 11-14, 2021 in Atlanta, Georgia and virtually. Findings from the RE-MIND2 study presented at ASH 2021 indicated that tafasitamab plus lenalidomide resulted in statistically significant differences across several endpoints. Specifically, results showed: The primary endpoint, overall survival (OS), was met with significant improvement observed for tafasitamab plus lenalidomide at 20.1 months compared to Pola-BR at 7.2 months (p=0.038), and 24.6 months for tafasitamab plus lenalidomide compared to 7.4 months for R2 (p=0.014). A comparable median OS benefit was observed with tafasitamab plus lenalidomide at 22.5 months compared to CAR-T at 15 months without statistical significance. Objective response rate (ORR), a key secondary endpoint, was observed with statistical significance for tafasitamab plus lenalidomide at 63.6% versus R2 at 30.3% (p=0.013). Tafasitamab plus lenalidomide also achieved significantly higher complete response rate (CR), a key secondary endpoint, at 39.4% versus 15.2% for R2 (p=0.0514). While safety endpoints were not included in this study, the most common adverse events (AEs) associated with tafasitamab plus lenalidomide are feeling tired or weak, diarrhea, cough, fever, swelling of lower legs or hands, respiratory tract infection and decreased appetite. Of 3,454 patients enrolled from 200 sites, 106, 106 and 149 patients were treated with pol-BR, R2 and CAR-T, respectively. For the comparative analysis, matched patient pairs were created using 1:1 nearest neighbor matching with a caliper. Matched pairs consisted of: tafasitamab + len vs pol-BR, n=24 pairs; vs R2, n=33; and vs CAR-T, n=37 pairs.

Incyte Announces Updated Data Demonstrating Rapid and Durable Responses of Parsaclisib in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas

2021-12-11 14:00:00

Incyte announced data from three ongoing Phase 2 studies evaluating parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kd), for the treatment of patients with relapsed or refractory follicular lymphoma (FL) (CITADEL-203), marginal zone lymphoma (MZL) (CITADEL-204) and mantle cell lymphoma (MCL) (CITADEL-205). These data were accepted as oral presentations at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held December 11–14, 2021 in Atlanta, Georgia and virtually. The primary endpoint for the CITADEL-203, -204 and -205 studies is objective response rate (ORR). Key secondary endpoints include complete response rate (CRR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety and tolerability. All radiology-based endpoints are based on independent review committee (IRC) assessment. Building on previous findings presented at ASH 2020, these updated data from the primary analysis continue to show treatment with parsaclisib resulted in a rapid and durable response with an acceptable safety profile, and supported the New Drug Application (NDA) for parsaclisib, recently accepted by the U.S. Food and Drug Administration (FDA). Follicular, Marginal Zone and Mantle Cell Lymphomas: Non-Hodgkin lymphoma (NHL) is a type of cancer that starts in the lymphocytes, a type of white blood cell. Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) are forms of B-Cell NHLs. FL and MZL are indolent or slow growing lymphomas; MCL is an aggressive or rapidly developing form. There is an unmet medical need for treatment options for patients who are relapsed or refractory to initial therapies. The CITADEL (Clinical Investigation of TArgeted PI3K-DELta Inhibition in Lymphomas) clinical trial program is evaluating parsaclisib in several ongoing studies as a treatment for adult patients with lymphomas, including: CITADEL-203 (NCT03126019) is evaluating patients with relapsed or refractory follicular lymphoma (FL) Grade 1, 2 or 3a who received at least two prior systemic therapies, had an Eastern Cooperative Oncology Group performance status (ECOG PS) =2, and were ineligible for hematopoietic stem cell transplantation (HSCT). CITADEL-204 (NCT03144674) is evaluating patients with relapsed or refractory marginal zone lymphoma (MZL) who received at least one prior systemic therapy and were Bruton’s tyrosine kinase (BTK) inhibitor treatment naive. Patients with prior ibrutinib treatment were initially allowed to enroll; however, the cohort was terminated due to slow enrollment. Eligible patients had radiologically measurable lymphadenopathy or extranodal lymphoid malignancy (or histologically confirmed bone marrow infiltration in cases of splenic MZL), and an ECOG PS =2. CITADEL-205 (NCT03235544) is evaluating patients with relapsed or refractory mantle cell lymphoma (MCL), who received one to three prior systemic therapies and were either naive to or were previously treated with a BTK inhibitor. Eligible patients had an ECOG PS =2, and radiologically measurable lymphadenopathy or extranodal lymphoid malignancy. Patients eligible for each trial were allocated to receive parsaclisib 20 mg once daily for eight weeks followed by either 20 mg once weekly (weekly-dosing group [WG]) or 2.5 mg once daily (daily-dosing group [DG]). Subsequently, daily dosing was selected as the preferred regimen and the WG patients were allowed to switch to DG. Prophylaxis for Pneumocystis jirovecii pneumonia (PJP) was required.

Incyte Corporation Presents at 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov-16-2021

2021-11-16 11:51:00

Incyte Corporation Presents at 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov-16-2021 . Speakers: Jim Lee, Group Vice President, Head Inflammation & Autoimmunity.

Hanson Wade Limited, 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov 16, 2021 through Nov 18, 2021

2021-11-15 12:30:00

Hanson Wade Limited, 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov 16, 2021 through Nov 18, 2021.

Incyte Corporation Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov-30-2021 02:15 PM

2021-11-09 13:00:00

Incyte Corporation Presents at 4th Annual Evercore ISI HealthCONx Virtual Conference, Nov-30-2021 02:15 PM.

Incyte Corporation Presents at BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov-08-2021 04:10 PM

2021-11-04 13:52:00

Incyte Corporation Presents at BMO Biopharma Spotlight Series: Emerging Trends & Therapeutics in Oncology, Nov-08-2021 04:10 PM. Speakers: Christiana Stamoulis, Executive VP & CFO, Hervé Hoppenot, Chairman, President & CEO, Steven H. Stein, Executive VP & Chief Medical Officer.

Incyte Corporation Presents at Pharma/Biotech GTN Summit, Nov-19-2021 09:45 AM

2021-11-03 17:32:00

Incyte Corporation Presents at Pharma/Biotech GTN Summit, Nov-19-2021 09:45 AM. Venue: Hilton Penn's Landing Hotel, Philadelphia, Pennsylvania, United States. Speakers: Tom Gayer, Vice President, Financial Planning and Analysi.

Incyte Corporation - Special Call

2021-11-01 13:16:00

To discuss its oral PD-L1 clinical development program, including data from INCB86550 which has been accepted for oral presentation at the SITC Annual Congress

Data from Incyte’s Oncology Portfolio Accepted for Presentation at the Society for Immunotherapy of Cancer (SITC) 2021 Annual Meeting

2021-11-01 13:16:00

Incyte announced that multiple abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting, held from November 10-14, 2021 in Washington, D.C and virtually. Key abstracts include: Late-Breaking Poster Presentation: Retifanlimab (INCMGA00012) in patients with recurrent MSI-H or dMMR endometrial cancer: Results from the POD1UM-101 Study (Abstract #956. November 13, 7:00 a.m. – 8:30 p.m. ET); Oral Presentation: Phase 1 study of INCB086550, an oral PD-L1 inhibitor, in immune-checkpoint naive patients with advanced solid tumors (Abstract #529. Session: Concurrent Rapid Oral Abstract Presentation: Clinical. November 13, 12:45 – 1:45 p.m. ET); Poster Presentation: A Phase 2 Study of Retifanlimab in Patients With Advanced or Metastatic Merkel Cell Carcinoma (MCC) (POD1UM-201) (Abstract #545. November 12, 7:00 a.m. – 8:30 p.m. ET); Full abstracts will be available on the SITC website and in the Journal for ImmunoTherapy of Cancer (JITC) on November 9, 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.

Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas

2021-11-01 11:00:00

Incyte announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kd), for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). The submission is based on data from several Phase 2 studies (CITADEL-203, -204 and -205) evaluating parsaclisib as a treatment for relapsed or refractory non-Hodgkin lymphomas (NHLs) (FL, MZL and MCL). Parsaclisib was generally well-tolerated in all studies with a manageable safety profile. Parsaclisib has been granted Priority Review by the FDA for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with MCL who have received at least one prior therapy. The FDA grants Priority Review to medicines that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. This designation shortens the review period by four months as compared to Standard Review so the Prescription Drug User Fee Act (PDUFA) target action date for these indications is April 30, 2022. The NDA for use of parsaclisib in adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies will have a Standard Review and a PDUFA target action date of August 30, 2022. Confirmatory phase 3 studies are in preparation for parsaclisib in patients with MCL (CITADEL-310) and relapsed or refractory FL and MZL (CITADEL-302).

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.

Incyte Announces the Validation of the European Marketing Authorization Application for Ruxolitinib Cream in Vitiligo

2021-10-28 11:47:00

Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream, a topical JAK inhibitor, as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement. The validation of the MAA by the European Medicines Agency (EMA) confirms that the submission is ready to enter the formal review process. The MAA is supported by data from the Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream in more than 600 people (age >12 years) with vitiligo. Results from the Phase 3 program, recently presented at the 30th European Academy of Dermatology and Venereology (EADV) congress during a late-breaking research session, showed significant improvements in facial and total body repigmentation at 24 weeks of treatment with ruxolitinib cream in people with vitiligo. In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions, and the overall safety profile was consistent with previous study data. Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes. Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis and progression of vitiligo. It affects approximately 0.5% to 2.0% of the population globally1 and there are no U.S. Food and Drug Administration (FDA) or EMA-approved drug therapies for regimentation in vitiligo. The disease can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 20.

Incyte Corporation to Report Q3, 2021 Results on Nov 02, 2021

2021-10-13 12:00:00

Incyte Corporation announced that they will report Q3, 2021 results at 7:00 AM, US Eastern Standard Time on Nov 02, 2021

Incyte Corporation, Q3 2021 Earnings Call, Nov 02, 2021

2021-10-13 12:00:00

Incyte Corporation, Q3 2021 Earnings Call, Nov 02, 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.

Incyte Announces Full Results From Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo

2021-10-02 09:15:00

Incyte announced the full 24-week results from its pivotal Phase 3 TRuE-V clinical trial program investigating ruxolitinib cream (Opzelura™), a topical JAK inhibitor, in adolescent and adult patients (age =12 years) with nonsegmental vitiligo. These data will be presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) 30thCongress, held virtually from September 29-October 2, 2021. Building on the previously announced positive topline results from the TRuE-V program, findings from the Week 24 analysis showed treatment with 1.5% ruxolitinib cream twice daily (BID) resulted in greater improvement to vehicle for the primary and all key secondary endpoints in both the TRuE-V1 and TRuE-V2 studies. Results, which were consistent across both studies, showed: At Week 24, 29.9% of patients applying ruxolitinib cream achieved =75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint. More than 51% of patients applying ruxolitinib cream achieved =50% improvement from baseline in F-VASI (F-VASI50), and more than 15% of patients applying ruxolitinib cream achieved =90% improvement from baseline in F-VASI (F-VASI90), key secondary endpoints. Additional key secondary endpoints were met, including a significantly greater proportion of patients achieving =50% improvement from baseline in total body Vitiligo Area Scoring Index (T-VASI50) and a Vitiligo Noticeability Scale (VNS) response with application of ruxolitinib cream compared to vehicle, and a significant improvement on percentage change from baseline in facial body surface area (F-BSA) with application of ruxolitinib cream compared to vehicle. The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data. In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions. Treatment-emergent adverse events were consistent with previous studies, with no serious treatment-related adverse events reported. As previously disclosed, based on these findings Incyte expects to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age =12 years) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) before the end of 2021. In September 2021, Opzelura™ (ruxolitinib) cream was approved by the FDA for the short-term and non-continuous treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Eli Lilly and Company and Incyte Announces Detailed Results from Two Pivotal Phase 3 Trials

2021-09-30 09:56:00

Eli Lilly and Company and Incyte announced detailed results from two pivotal Phase 3 trials (BRAVE-AA1 and BRAVE-AA2), which found once-daily OLUMIANT® (baricitinib) 4-mg was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe alopecia areata (AA) as defined by =50% scalp hair loss at baseline. Significant improvements in scalp hair regrowth compared to placebo were achieved at 36 weeks for patients taking OLUMIANT 2-mg and 4-mg oral doses, as previously disclosed in topline findings from BRAVE-AA1 and BRAVE-AA2 earlier this year. In both studies, a greater proportion of patients taking OLUMIANT 4-mg compared to placebo also achieved full regrowth or regrowth with minimal gaps in coverage of eyebrow and eyelash hair at 36 weeks, which were key secondary endpoints of the studies. These results, along with safety data in adult patients with moderate to severe atopic dermatitis (AD), are being presented virtually at the 30thEuropean Academy of Dermatology and Venerology (EADV) Congress, taking place from Sept. 29-Oct. 2, 2021. Alopecia areata is a widely misunderstood, autoimmune disease that can cause extreme and patchy hair loss on the scalp, face and other areas of the body, along with emotional distress and psychosocial effects. OLUMIANT has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. Lilly plans to submit a supplemental New Drug Application (sNDA) to the FDA for OLUMIANT in AA in the second half of 2021. In BRAVE-AA1 and BRAVE-AA2, the first completed, randomized, double-blind, placebo-controlled Phase 3 trials for AA, 598 and 490 patients, respectively, underwent 36 weeks of treatment. Both studies included adults with severe AA, defined as a Severity of Alopecia Tool (SALT) score =50 (those with =50% scalp hair loss). At baseline, the participants had a mean SALT score of 85.5 (85.5% scalp hair loss, or 14.5% scalp hair coverage). Across treatment groups, the average age of participants was 37.5 years old, and they had lived with AA for a mean of 12.2 years since first experiencing symptoms, with the onset for hair loss occurring at approximately age 25. In BRAVE-AA1, statistically significant improvement in scalp hair regrowth occurred as early as 16 weeks among patients treated with OLUMIANT 4-mg and 24 weeks with OLUMIANT 2-mg, compared to placebo. At 16 weeks, nearly 1 in 5 patients (18.5%, n=52) taking OLUMIANT 4-mg achieved 80% or more scalp hair coverage (as measured by a SALT score =20) as compared to placebo (4.2%, n=8, p=0.001). At 24 weeks, 1 in 10 patients (11.4%, n=21) taking OLUMIANT 2-mg achieved 80% or more scalp hair coverage as compared to placebo (4.8%, n=9, p=0.013). In BRAVE-AA2, statistically significant improvement occurred as early as 24 weeks for patients treated with OLUMIANT 4-mg, with more than 1 in 4 patients (28.2%, n=66) reaching 80% or more scalp hair coverage as compared to placebo (1.3%, n=2, p=0.001). Across both studies at 36 weeks – the study's primary endpoint – 1 out of 3 patients treated with OLUMIANT 4-mg (BRAVE-AA1=35.2% [n=99]; BRAVE-AA2=32.5% [n=76]) and approximately 1 out of 5 patients treated with OLUMIANT 2-mg (BRAVE-AA1=21.7% [n=40]; BRAVE-AA2=17.3% [n=27]) achieved 80% or more scalp hair coverage, compared to 5.3% of patients taking placebo (n=10) and 2.6% (n=4) in BRAVE-AA1 and BRAVE-AA2, respectively (p=0.001 for all comparisons to placebo). Achievement of full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair was also seen at 36 weeks with OLUMIANT 4-mg for 1 in 3 patients who at baseline had significant gaps or no notable eyebrows, as compared to patients taking placebo (BRAVE-AA1 eyebrow=31.4% [n=59]; BRAVE-AA1 eyelash=33.5% [n=56]; BRAVE-AA1 eyebrow placebo=3.2% [n=4]; BRAVE-AA1 eyelash placebo=3.1% [n=3]; BRAVE-AA2 eyebrow=34.8% [n=56]; BRAVE-AA2 eyelash=34.3% [n=48]; BRAVE-AA2 eyebrow placebo=4.5% [n=5]; BRAVE-AA2 eyelash placebo=5.6% [n=5]). This was measured by Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss™ and ClinRO Measure for Eyelash Hair Loss™ scores of patients achieving eyebrow and eyelash hair loss scores of 0 or 1 (full coverage or minimal gaps) with a =2-point improvement from baseline at 36 weeks, respectively, compared to placebo. Statistically significant eyebrow regrowth results (19.1%, n=26, p=0.001) were also found for OLUMIANT 2-mg in BRAVE-AA1 at 36 weeks, but not in BRAVE-AA2. Eyelash results were not statistically significant with OLUMIANT 2-mg in either study. In a pooled analysis across eight studies, tolerability outcomes for acne, headache and GI adverse events (diarrhea, abdominal pain, nausea, vomiting and constipation) were evaluated in more than 2,500 adult patients with moderate to severe atopic dermatitis (AD) taking OLUMIANT 2-mg and 4-mg once daily. Among those patients treated with OLUMIANT, 2.9% of patients (n=74/2,531) had an adverse event of acne and 6.6% had an adverse event of headache (n=166/2,531). The most common gastrointestinal events were diarrhea (3.1% [n=78/2,531]) and nausea (1.9% [n=49/2,531]). Most of these events were mild to moderate in severity. The number of patients with adverse events that were assessed as severe was low, with 10 patients (0.4%) reporting severe adverse events (4 due to headache, 2 due to diarrhea, 1 due to abdominal pain, 1 due to upper abdominal pain, 1 due to nausea and 1 due to vomiting). A total of 6 patients (0.2%) had temporary study interruptions (4 due to headache, 1 due to vomiting and 1 due to abdominal pain), and 5 patients (0.2%) permanently discontinued (2 due to headache, 1 due to nausea and 2 due to abdominal pain) for any of these events.

Incyte Corporation Elects Otis W. Brawley Member of the Board of Directors

2021-09-28 20:48:00

Effective September 27, 2021, the Board of Directors of Incyte Corporation (the ‘Company’) increased the number of authorized members of the Board of Directors of the Company to nine and elected Otis W. Brawley, M.D., a member of the Board of Directors of the Company. Dr. Brawley has served as a Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University since January 2019.

Syndax Pharmaceuticals and Incyte Announce Global Collaboration to Develop and Commercialize Axatilimab for Chronic Graft-Versus-Host Disease and Other Fibrotic Diseases

2021-09-27 10:00:00

Syndax Pharmaceuticals, Inc. and Incyte announced that they have entered into an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab, Syndax's anti-CSF-1R monoclonal antibody. Syndax and Incyte are seeking to develop axatilimab as a backbone therapy for patients with cGVHD as well as in additional immune-mediated diseases where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis. Syndax recently completed a Phase 1/2 trial of axatilimab in patients with cGVHD. Data from the Phase 1 portion of the trial highlighting the tolerability and high response rate of axatilimab in cGVHD patients refractory to multiple therapeutic agents were reported during an oral presentation at the American Society of Hematology Annual Meeting in December 2020. Updated results from the Phase 1 portion and preliminary results from the Phase 2 expansion portion of the study, which evaluated 1 mg/kg of axatilimab every two weeks, are expected to be presented at a medical meeting in the fourth quarter of 2021. Enrollment continues in the ongoing global pivotal Phase 2 AGAVE-201 trial of axatilimab monotherapy in patients with cGVHD, with topline data expected in 2023. The companies also plan to initiate additional trials of axatilimab in patients with cGVHD in 2022, including a Phase 2 trial in combination with a JAK inhibitor in patients with steroid-refractory cGVHD. Beyond cGVHD, Syndax plans to commence a Phase 2 proof of concept trial of axatilimab early next year in patients with IPF, a serious, life-limiting orphan disease for which axatilimab could represent a much-needed treatment option with a novel mechanism of action. Under the terms of the agreement, Incyte will lead global commercial activities for axatilimab across all indications. The companies will participate in a 50:50 profit share in the U.S., and Syndax will receive double-digit royalties on sales outside of the U.S. Syndax will retain the option to co-promote axatilimab for any approved indications in the U.S. In connection with the agreement, Syndax will receive an upfront payment of $117 million plus a $35 million equity investment, which will be purchased at $24.62 per share, a 30% premium to the volume weighted average price over the 10 days prior to September 24, 2021. Syndax will also be eligible to receive up to an additional $450 million in potential regulatory, development and commercial milestone payments. The companies will share development costs associated with global and U.S.-specific trials for all agreed upon trials at a rate of 55% (Incyte) and 45% (Syndax), with Incyte responsible for 100% of future development costs for trials that are specific to ex-U.S. countries. Syndax will fund the initial development of axatilimab in IPF and Incyte will have the option to co-fund late-stage development for this indication. The agreement between Syndax and Incyte, including the upfront payment and equity investment, is subject to clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act and will become effective as soon as these conditions have been met. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Syndax.

Incyte Corporation - Special Call

2021-09-27 10:00:00

To discuss Global Collaboration between Syndax Pharmaceuticals and Incyte to Develop and Commercialize Axatilimab for Chronic Graft-Versus-Host Disease and Other Fibrotic Diseases and and the Company's recent product approval in chronic GVHD

Syndax Pharmaceuticals, Inc. announced that it expects to receive $34.997896 million in funding from Incyte Corporation

2021-09-24 00:00:00

Syndax Pharmaceuticals, Inc. announced a private placement of 1,421,523 shares at a price of $24.62 per share for gross proceeds of $35 million on September 24, 2021. The transaction will include participation from Incyte Corporation.

Incyte Announces FDA Approval of Jakafi® (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD)

2021-09-22 16:38:00

Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. The FDA approval was based on the REACH3 study, a Phase 3, randomized, open-label, multicenter study of Jakafi in comparison to best available therapy (BAT) for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation. The primary endpoint of overall response rate (ORR) at Week 24 (i.e., Cycle 7 Day 1) was 49.7% for Jakafi compared to 25.6% for BAT (P<0.0001). Furthermore, the ORR through Cycle 7 Day 1 was 70% for Jakafi compared to 57% for BAT2. The most common hematologic adverse reactions (incidence > 35%) were anemia and thrombocytopenia. The most common nonhematologic adverse reactions (incidence = 20%) were infections (pathogen not specified) and viral infection. Full results from the REACH3 study were published in the New England Journal of Medicine (NEJM). GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient’s organs. There are two major forms of GVHD: acute, which generally occurs within 100 days of transplant, and chronic, which generally occurs more than 100 days after transplant. Both forms are associated with significant morbidity and mortality and can affect multiple organ systems. Jakafi’s supplemental New Drug Application (sNDA) in chronic GHVD was reviewed under the FDA’s Priority Review program as well as the Project Orbis program, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. Participating countries for this application include Canada, Australia, Switzerland, Brazil and the United Kingdom.

Incyte Corporation Provides Revenue Guidance for the Year 2022

2021-09-22 12:00:00

Incyte Corporation announced that the company anticipates during the fourth quarter of this year to have, as mentioned, a higher gross to net due to the higher uptake of the patient support programs and co-pay cards. And so the company would expect that to have an impact relative to revenue generation within the fourth quarter. Thereafter, as the company roll into 2022 and are able to secure meaningful access with the payers and reduce the utilization of those programs, and that's when the company expects the revenue to start to ramp.

Incyte Corporation - Special Call

2021-09-21 20:13:00

To discuss the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable

Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD)

2021-09-21 20:13:00

Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelurais the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features of AD such as itch, inflammation and skin barrier dysfunction. The FDA approval was based on data from the TRuE-AD (Topical Ruxolitinib Evaluation in Atopic Dermatitis) clinical trial program, consisting of two randomized, double-blind, vehicle-controlled Phase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of Opzelurain more than 1,200 adolescents and adults with mild to moderate AD. Results from the studies showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily (BID), compared to vehicle (non-medicated cream): Significantly more patients treated with Opzeluraachieved Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS, primary endpoint) at Week 8 (defined as an IGA score of 0 [clear] or 1 [almost clear] with at least a 2-point improvement from baseline): 53.8% in TRuE-AD1 and 51.3% in TRuE-AD2, compared to vehicle (15.1% in TRuE-AD1, 7.6% in TRuE-AD2; P<0.0001). Significantly more patients treated with Opzeluraexperienced a clinically meaningful reduction in itch from baseline at Week 8, as measured by a =4-point reduction in the itch Numerical Rating Scale (itch NRS4): 52.2% in TRuE-AD1 and 50.7% in TRuE-AD2, compared to vehicle (15.4% in TRuE-AD1, 16.3% in TRuE-AD2; P<0.0001), among patients with an NRS score of at least 4 at baseline. In clinical trials, the most common (=1%) treatment-emergent adverse reactions in patients treated with Opzelura were nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis and rhinorrhea. See Important Safety Information below, including Boxed Warnings for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis, seen with JAK inhibitors for inflammatory conditions. AD is a chronic skin disease affecting more than 21 million people aged 12 years and older in the U.S. and is characterized by inflammation and itch. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral and fungal infections.

Incyte Corporation Presents at Indegene Digital Summit, Sep-24-2021 09:30 AM

2021-09-21 16:13:00

Incyte Corporation Presents at Indegene Digital Summit, Sep-24-2021 09:30 AM. Speakers: Kenneth Coyle, VP - Business Operations.

Incyte Announces Health Canada Conditional Approval of Pemazyre® (pemigatinib) as First Targeted Treatment for Adults

2021-09-17 20:00:00

Incyte announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. The conditional approval is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma. Study results demonstrated that in patients harbouring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 35.5% (primary endpoint) and median duration of response (DOR) of 9.1 months (secondary endpoint) with a median follow-up of 15.4 months. Adverse events observed included serous retinal detachment (SRD) and hyperphosphatemia. The most common adverse reactions (incidence =15%) are hyperphosphatemia, alopecia, diarrhea, fatigue, nail toxicity, dysgeusia, nausea, constipation, stomatitis, dry mouth, decreased appetite, vomiting, dry eye, arthralgia, abdominal pain, hypophosphatemia, dry skin, edema peripheral, weight decreased, headache, urinary tract infection, dehydration, hypercalcemia, and palmar-plantar erythrodysaesthesia syndrome. Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its anatomical origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver, and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor.1,2 The incidence of cholangiocarcinoma varies regionally and ranges between 0.3-3.4 per 100,000 in North America and Europe.1 FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16% of patients.3,4,5,6 FGFRs play an important role in tumour cell proliferation and survival, migration, and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations, and gene amplifications in FGFRs are closely correlated with the development of various cancers. About FIGHT-202: The FIGHT-202 is a multi-center, open-label, single-arm, Phase 2 study (NCT02924376) that evaluated the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age =18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genomic alterations) or Cohort C (no FGF/FGFR genomic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity. The primary endpoint of FIGHT-202 was overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, A plus B, and C; and duration of response (DOR).

Calithera Biosciences, Inc. Enters into A Settlement Agreement and Release with Incyte Corporation

2021-09-16 20:01:00

In January 2017, Calithera Biosciences Inc. and Incyte Corporation entered into a Collaboration and License Agreement, or the License Agreement. Pursuant to the License Agreement, Calithera Biosciences’s product candidate INCB001158 is being developed by Incyte for oncology and hematology indications. INCB001158 is an oral inhibitor of arginase, an immunosuppressive enzyme that depletes the amino acid arginine, a key metabolic nutrient required for activation of T-cells. On April 10, 2020, Calithera Biosciences filed a complaint against Incyte in the Superior Court of California asserting claims for breach of contract arising out of Incyte’s failure to pay two milestone payments believe are due under agreement with Incyte. On September 14, 2021, The company entered into a Settlement Agreement and Release with Incyte, or the Settlement Agreement. Pursuant to the Settlement Agreement, which resolves all claims in the complaint without any admission of liability or fault, Incyte will pay Calithera Biosciences a negotiated settlement amount and the parties have exchanged mutual releases. Concurrently, the parties also filed a dismissal of the action in the Superior Court of California.

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.

Nimble Therapeutics and Incyte Expand Their Strategic Research Collaboration to Discover Additional Novel Peptide Therapeutics

2021-09-14 13:00:00

Nimble Therapeutics announced their strategic research collaboration with Incyte has been expanded to include discovery of additional novel peptide therapies. Under the terms of the agreement, Nimble will receive an upfront payment and reimbursement of certain research program costs and may become eligible for downstream milestone payments and royalties. Incyte has exclusive rights to develop and commercialize any peptides discovered under the collaboration and has an option to further expand the collaboration to include additional targets.

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.

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.

Incyte Announces Health Canada Approval of Minjuvi® in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

2021-08-24 12:30:00

Incyte announced that Health Canada has granted a Notice of Compliance with conditions for Minjuvi® (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT). The conditional approval is based on data from the L-MIND study, an open label, multicentre single arm study evaluating the safety and efficacy of Minjuvi in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for ASCT, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. Removal of the conditions from the Notice of Compliance is contingent upon verification and description of clinical benefit in a confirmatory trial(s). The results from L-MIND showed an overall response rate (ORR) of 53.5% (primary endpoint), including a complete response (CR) rate of 35.2% and a partial response rate (PR) of 18.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 34.6 months (secondary endpoint). Adverse events (AEs) reported included infusion-related reactions, serious or severe myelosuppression, including neutropenia, thrombocytopenia, anemia, infections and tumour lysis syndrome.

Incyte Corporation and Incyte Holdings Corporation Enters into Revolving Credit and Guaranty Agreement

2021-08-20 20:02:00

Incyte Corporation and its subsidiary, Incyte Holdings Corporation entered into a revolving credit and guaranty agreement among the company, as borrower, Incyte Holdings, as a guarantor, the lenders from time to time party thereto J.P. Morgan Chase Bank, N.A. as administrative agent, and the other financial institutions party thereto. Under the Credit Agreement, the Lenders have committed to provide an unsecured three-year revolving credit facility in an aggregate principal amount of up to $500.0 million. The company may increase the maximum revolving commitments or add one or more incremental term loan facilities to the Credit Agreement, subject to obtaining commitments from any participating lenders and certain other conditions, in an amount not to exceed (1) $250.0 million plus (2) an additional amount, so long as after giving effect to the incurrence of such additional amount, the Company’s pro forma consolidated leverage ratio would not exceed 0.25 above its consolidated leverage ratio in effect immediately prior to giving effect to such increase. Subject to certain customary exceptions, in addition to Incyte Holdings, the obligations under the Credit Agreement will be guaranteed by each of the company’s existing and future, direct or indirect, material domestic subsidiaries. Loans under the Credit Agreement will bear interest, at the company’s option, at a per annum rate equal to either (a) a base rate plus an applicable rate per annum varying from 0.125% to 0.875% depending on the Company’s consolidated leverage ratio or (b) a Eurodollar rate plus an applicable rate per annum varying from 1.125% to 1.875% depending on the company’s consolidated leverage ratio. Commitment fees payable on the undrawn amount range from 0.150% per annum to 0.225% per annum, based on the company’s consolidated leverage ratio.

Incyte Corporation Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-13-2021 11:45 AM

2021-08-17 12:00:00

Incyte Corporation Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-13-2021 11:45 AM. Venue: New Windsor, United States.

MorphoSys’ Partner Incyte Announces Development and Commercialization Agreement with InnoCare for Tafasitamab in Greater China

2021-08-17 11:05:00

MorphoSys AG announced that Incyte, its development and commercialization partner for tafasitamab, entered into a collaboration and license agreement with a subsidiary of InnoCare for tafasitamab in Greater China. Under the terms of the agreement, InnoCare will receive the rights to develop and exclusively commercialize tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in hematology-oncology in mainland China, Hong Kong, Macau and Taiwan. In January 2020, MorphoSys and Incyte entered into a collaboration and license agreement to develop and commercialize MorphoSys’ proprietary anti-CD19 antibody tafasitamab globally. MorphoSys and Incyte co-commercialize tafasitamab in the U.S., and Incyte holds the development and commercialization rights for tafasitamab outside the U.S. MorphoSys will receive tiered royalties on ex-U.S. net sales.

Incyte and Innocare Announce Collaboration and License Agreement for Tafasitamab in Greater China

2021-08-17 00:00:00

Incyte and InnoCare announced that Incyte and a subsidiary of InnoCare have entered into a collaboration and license agreement for the development and commercialization of tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in Greater China. Under the terms of the agreement, InnoCare will pay Incyte USD 35 million up front, and Incyte is eligible to receive up to an additional US$82.5 million in potential development, regulatory and commercial milestones, as well as tiered royalties. InnoCare will receive the rights to develop and exclusively commercialize tafasitamab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.

Eli Lilly and Company and Incyte Announce Results from an Additional Cohort of 101 Adult Patients from the COV-Barrier Trial

2021-08-03 10:00:00

Eli Lilly and Company and Incyte announced results from an additional cohort of 101 adult patients from the COV-BARRIER trial. In this sub-study, patients with COVID-19 on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) who received baricitinib plus standard of care were 46 percent less likely to die by Day 28 compared to patients who received placebo plus standard of care (nominal p-value=0.0296; hazard ratio [HR] [95% CI] = 0.54 [0.31, 0.96]; analysis not adjusted for multiplicity). The cumulative proportion of patients who died by Day 28 was 39.2 percent (n/N: 20/51) in the baricitinib arm versus 58 percent in the placebo arm (n/N: 29/50). Similar mortality benefit was observed by Day 60 (HR [96% CI] = 0.56 [0.33, 0.97]) with a cumulative proportion of death of 45.1 percent (n/N: 23/51) for baricitinib compared to 62.0 percent for placebo (n/N: 31/50). These findings are consistent with the reduction in mortality observed in the overall COV-BARRIER patient population. By Day 28, the frequency of adverse events, serious adverse events and serious infections were similar in the baricitinib group (88%, 50% and 44%, respectively) compared to placebo (95.9%, 71.4% and 53.1%, respectively). Venous thromboembolic events were reported in 6 percent of patients treated with baricitinib and 6.1 percent of patients treated with placebo. No new safety signals were identified. Lilly intends to publish detailed results from this additional sub-study in a peer-reviewed journal and present the findings at a medical meeting in the coming months. These new data from the COV-BARRIER sub-study will also be shared with regulatory authorities in the U.S., European Union and other geographies. On July 28, 2021, the U.S. Food and Drug Administration (FDA) broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir. The EUA provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or ECMO.

Fda Broadens Existing Emergency Use of Lilly and Incyte's Baricitinib in Patients Hospitalized with COVID-19 Requiring Oxygen

2021-07-29 13:26:00

Eli Lilly and Company and Incyte announced the U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. The EUA now provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). The FDA based decision on data from the Phase 3 COV-BARRIER study, announced April 8, 2021. COV-BARRIER was a randomized, double-blind, placebo-controlled study of hospitalized patients comparing baricitinib 4 mg once daily plus standard of care versus placebo plus standard of care. Patients could remain on background standard of care, as defined per local guidelines, including antimalarials, antivirals, corticosteroids, and/or azithromycin. The most frequently used therapies were corticosteroids (79% of patients, mostly dexamethasone) and remdesivir (19% of patients). While the composite primary endpoint of COV-BARRIER, which was defined as a difference in the estimated proportion of participants progressing to non-invasive ventilation including high flow oxygen or invasive mechanical ventilation (including ECMO) or death by Day 28, did not meet statistical significance, baricitinib-treated patients (27.8%) were less likely than those receiving standard of care (30.5%) to progress to ventilation or death (odds ratio [OR]: 0.85; 95% CI: 0.67, 1.08; p=0.180). A pre-specified key secondary endpoint showed baricitinib, in addition to standard of care, meaningfully reduced the risk of death by 39% by Day 28 when compared to standard of care alone (n/N: 62/764 [8.1%] baricitinib, 101/761 [13.3%] placebo; [estimated difference in Day 28 probability of mortality = -4.9% (95% CI: -8.0%, -1.9%); hazard ratio [HR] = 0.56 (95% CI: 0.41, 0.77)]. No new safety signals potentially related to the use of baricitinib were identified. The study findings have been submitted to a peer-reviewed journal for future print publication.

Eli Lilly and Company and Incyte Corporation Provide Update on Supplemental New Drug Application for Baricitinib for the Treatment of Moderate to Severe Atopic Dermatitis

2021-07-16 14:00:00

Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration will not meet the Prescription Drug User Fee Act action date for the supplemental new drug application for baricitinib for the treatment of adults with moderate to severe atopic dermatitis. The delay is related to the FDA's ongoing assessment of JAK inhibitors. Baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, is approved for the treatment of adults with moderately to severely active rheumatoid arthritis in more than 75 countries. It is also approved in over 40 countries for the treatment of adults with moderate to severe AD who are candidates for systemic therapy and approved in Japan for the treatment of certain hospitalized patients with COVID-19. Baricitinib is being studied in alopecia areata, systemic lupus erythematosus and juvenile idiopathic arthritis. Indication and Usage for OLUMIANT (baricitinib) tablets for RA patients: OLUMIANT 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs, or with potent immunosuppressants such as azathioprine and cyclosporine.

Incyte Corporation to Report Q2, 2021 Results on Aug 03, 2021

2021-07-15 12:00:00

Incyte Corporation announced that they will report Q2, 2021 results at 7:00 AM, US Eastern Standard Time on Aug 03, 2021

Incyte Corporation, Q2 2021 Earnings Call, Aug 03, 2021

2021-07-15 12:00:00

Incyte Corporation, Q2 2021 Earnings Call, Aug 03, 2021

Incyte Announces Positive Phase 3 REACH3 Study Data Published in NEJM for Ruxolitinib (Jakafi) in Chronic Graft-Versus-Host Disease

2021-07-14 21:00:00

Incyte announced that positive data from the Phase 3 REACH3 study have been published in The New England Journal of Medicine (NEJM) demonstrating that treatment with ruxolitinib (Jakafi) resulted in significantly improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT). The study’s main findings, previously presented at the 62nd American Society of Hematology (ASH) Annual Meeting, were published along with new subgroup analyses showing favorable overall response rate (ORR) at Week 24 for ruxolitinib across all major subgroups, including baseline individual organ involvement. REACH3 is jointly sponsored by Incyte and Novartis. The study found that treatment with ruxolitinib led to significant improvements in ORR at Week 24 (49.7% vs. 25.6%; odds ratio [OR], 2.99; P<0.001i), the primary endpoint of the study1. Also, best overall response (BOR) rate at any time up to Week 24 was achieved in 76.4% of patients in the ruxolitinib arm compared to 60.4% of patients in the BAT arm (OR, 2.17; 95% CI, 1.34-3.52)1. Ruxolitinib also demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints: Patients on ruxolitinib achieved longer failure-free survival (FFS) than patients receiving BAT (median FFS not yet reached vs. 5.7 months; hazard ratio, 0.37; 95% CI, 0.27 to 0.51; P<0.0001). Patients treated with ruxolitinib also had greater improvements in self-reported symptoms compared to BAT1 (modified Lee Symptom Scale [mLSS] responder rate: 24.2% vs. 11.0%; OR, 2.62; P=0.001). In addition, a new subgroup analysis included in the publication found that patients on ruxolitinib had better outcomes regardless of the individual organs affected at baseline. No new safety signals were observed in REACH3, and adverse events (AEs) attributable to treatment were consistent with the known safety profile of ruxolitinib1. The most common AEs of grade 3 or higher in the ruxolitinib vs. BAT arms were thrombocytopenia (15.2% vs. 10.1%), anemia (12.7% vs. 7.6%), neutropenia (8.5% vs. 3.8%) and pneumonia (8.5% vs. 9.5%). While 37.6% and 16.5% of patients required ruxolitinib and BAT dose modifications due to AEs, respectively, the percentage of patients who discontinued treatment due to AEs was 16.4% in the ruxolitinib arm vs. 7% in the BAT arm. Mortality rates were similar across treatment arms (18.8% in the ruxolitinib arm vs. 16.5% in the BAT arm). Deaths reported as primarily due to chronic GVHD complications and/or its treatment were higher in the ruxolitinib vs. BAT arms (13.3% vs. 7.9%, respectively). The REACH3 data serve as the basis for the Company’s supplemental New Drug Application (sNDA) for ruxolitinib for the treatment of steroid-refractory chronic GVHD in adult and pediatric patients 12 years and older, which was accepted for review by the U.S. Food and Drug Administration (FDA) and has a Prescription Drug User Fee Act (PDUFA) target action date of September 22, 2021. GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) where the donated cells initiate an immune response and attack the transplant recipient’s organs, leading to significant morbidity and mortality. There are two major forms of GVHD: acute, which generally occurs within 100 days of transplant, and chronic, which generally occurs more than 100 days after transplant2. GVHD can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.

Incyte Corporation Presents at 2nd Annual JAK Inhibitors Drug Development Digital Event, Jun-29-2021 through Jul-01-2021

2021-06-29 12:23:00

Incyte Corporation Presents at 2nd Annual JAK Inhibitors Drug Development Digital Event, Jun-29-2021 through Jul-01-2021. Presentation Date & Speakers: Jul-01-2021, Jim Lee, Group Vice President, Head of Inflammation and Autoimmunity. Jun-30-2021, Paul Smith, Senior Director Pharmacology (non-oncology).

Hanson Wade Limited, 2nd Annual JAK Inhibitors Drug Development Digital Event, Jun 29, 2021 through Jul 01, 2021

2021-06-29 12:00:00

Hanson Wade Limited, 2nd Annual JAK Inhibitors Drug Development Digital Event, Jun 29, 2021 through Jul 01, 2021.