Loading..

Albireo Presents New Bylvay® (odevixibat) Data at Annual ESPGHAN Congress

2022-06-24 12:30:00

Albireo Pharma, Inc. announced the presentation of new data at the annual meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) being held in Copenhagen, Denmark. The data provided new analyses of the Phase 3 PEDFIC 1 and PEDFIC 2 trials of Bylvay® (odevixibat), demonstrating that dose escalation can provide greater benefits in relieving patients’ pruritus, with similar tolerability, as well as showing that reductions in pruritus are associated with important improvements in sleep and other quality of life measures in children with all types of progressive familial intrahepatic cholestasis (PFIC). Bylvay is a potent, non-systemic once daily ileal bile acid transport inhibitor (IBATi) that is the only treatment approved in Europe for the treatment of all types of PFIC in patients aged 6 months or older and the only treatment approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC. The PEDFIC 1 trial was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids (sBAs) in a randomized, double-blind, placebo-controlled trial, and PEDFIC 2 is a long-term, open-label Phase 3 extension study. Oral Presentation: Efficacy and Safety Outcomes in Patients with Progressive Familial Intrahepatic Cholestasis Who Had an Odevixibat Dose Escalation: Pooled Results from the PEDFIC 1 and PEDFIC 2 Studies. In the pooled analysis population (N=84), 21 patients with PFIC treated with Bylvay who had a treatment response on 40 µg/kg/day maintained their response and/or had further improvements with dose escalation to 120 µg/kg/day. Among those with dose escalation, additional patients became pruritus responders at the higher dose and some non-responders became pruritus responders at the higher dose in the PEDFIC studies. Bylvay was generally well tolerated throughout dose escalation. In patients who received 40 µg/kg/day of Bylvay during PEDFIC 1 and escalated to 120 µg/kg/day in PEDFIC 2, the majority of TEAEs were mild or moderate in severity. Long-Term Data Demonstrate Efficacy of Bylvay Across PFIC Subtypes: Oral Presentation: Analysis of Quality of Life, Hepatic Biochemical Markers, and Sleep in Patients With Progressive Familial Intrahepatic Cholestasis Who Had a Pruritus Response With Odevixibat Treatment. Results of pooled analysis population of 82 patients treated with Bylvay including 44 pruritus responders of PEDFIC 1 and PEDFIC 2 show that patients across various types of PFIC who had a pruritus response with Bylvay experienced improvements in quality of life, sleep and hepatic biomarkers that were sustained for up to 72 weeks. From baseline to week 72, pruritus responders had significant quality of life improvements, as assessed by mean PedsQL total scores (p=0.048) and PedsQL FI total scores (p=0.007). Data also indicated that pruritus responders had significant improvements in several caregiver-reported sleep parameters (all P<0.001), including reductions in days with blood due to scratching, days needing help falling asleep, days needing soothing, and days sleeping with caregiver. Among all pruritus responders, 86% had any TEAE, none of which were drug related serious TEAEs.?Two patients experienced TEAEs that led to study discontinuation, which included splenomegaly, diarrhoea, jaundice, decreased weight, and/or hypophagia?. Oral Presentation: Changes in Hepatic Parameters, Growth, Sleep, and Biochemical Markers With Odevixibat Treatment Across Patients With Various Types of Progressive Familial Intrahepatic Cholestasis. Patients with all types of PFIC treated with Bylvay for up to 72 weeks, with some tracked up to 128 weeks, experienced reductions in autotaxin levels and increases in C4 levels, as well as variable changes in hepatic parameters, sleep characteristics and growth. 84 patients received Bylvay during the pooled analysis period. Patients of almost all PFIC types experienced mean improvements in caregiver-reported sleep parameters. Patients of most PFIC types generally had mean increases in height and/or weight Z scores with Bylvay treatment; patients with PFIC1 and PFIC3 experienced more variable changes in weight Z scores. Among all patients, 85% had any TEAE, which was similar across all PFIC types and mild or moderate in severity?. All serious TEAEs were assessed as unrelated to study drug. Evidence of Bylvay Efficacy, With and Without Concomitant UDCA. e-Poster Abstract #363: Total, Primary, and Secondary Serum Bile Acid Concentrations in Patients With Progressive Familial Intrahepatic Cholestasis With Serum Bile Acid Response or Not With Odevixibat Treatment: Assessing the Contribution of Ursodeoxycholic Acid Concentration. A large proportion of patients in the PEDFIC 1 trial were on UDCA at baseline, but still had elevated sBAs and pruritus. This analysis assessed whether excluding UDCA concentrations from total sBA measurements altered the proportion of patients who had a sBA response to Bylvay and showed no appreciable changes. Moreover, patients who had a sBA response experienced large reductions in sBAs, whether or not they were on concomitant UDCA.

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell 2000 Value Index

2022-06-24 00:00:00

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell 2000 Value Index

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell 3000 Value Index

2022-06-24 00:00:00

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell 3000 Value Index

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell Small Cap Comp Value Index

2022-06-24 00:00:00

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell Small Cap Comp Value Index

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell 2500 Value Index

2022-06-24 00:00:00

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell 2500 Value Index

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell Microcap Value Index

2022-06-24 00:00:00

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell Microcap Value Index

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell 3000E Value Index

2022-06-24 00:00:00

Albireo Pharma, Inc.(NasdaqCM:ALBO) dropped from Russell 3000E Value Index

Albireo Pharma, Inc. Presents at The International Liver Congress 2022, Jun-23-2022 07:30 AM

2022-06-23 13:12:00

Albireo Pharma, Inc. Presents at The International Liver Congress 2022, Jun-23-2022 07:30 AM. Venue: London, United Kingdom.

Albireo Pharma, Inc. Announces Presentation of New Data in Pediatric and Adult Liver Diseases

2022-06-23 12:30:00

Albireo Pharma, Inc. announced the presentation of new data in pediatric and adult liver diseases at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022 being held in London. The presentations provide new analyses of the Phase 3 PEDFIC 1 and PEDFIC 2 trials of Bylvay® (odevixibat) in progressive familial intrahepatic cholestasis (PFIC), as well as data on pipeline ASBT/NTCP inhibitor compounds, including A2342 in Hepatitis B and D. Albireo also launched SPARK, a new grant-based program established to identify and drive improvements in the quality of care for rare liver diseases, beginning with PFIC in 2022. SPARK is designed to encourage new ideas with the potential to demonstrate best practices in patient-centered care. The Company presented data on Bylvay in five posters. Bylvay is a potent, non-systemic once daily ileal bile acid transport inhibitor (IBATi) that is the only treatment approved in Europe for the treatment of all types of PFIC in patients aged 6 months or older and the only treatment approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC. The PEDFIC 1 trial was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids (sBAs) in a randomized, double-blind, placebo-controlled trial, and PEDFIC 2 is a long-term, open-label Phase 3 extension study. Key findings from the data include: Bylvay Responders Experience Improvements in Quality of Life Measures (poster #763). This analysis of pooled data from the PEDFIC studies reveals that all patients had large quality of life deficits at baseline across emotional functioning, social functioning, physical functioning and school functioning, with mean scores between 47 and 67 on the PedsQL. Patients who responded to Bylvay treatment, and particularly their families, experienced mean quality of life improvements that were sustained over time, while quality of life for patients who did not respond to Bylvay was largely unchanged for them and their families. Of 84 total patients in the pooled population, PedsQL data were available for 53 patients, and PEDsQL Family Impact (FI) data were available for 79 patients. Among patients with available QoL data, both responders and non-responders had impaired QoL at least some of the time at baseline. PEDsQL total scores showed improved QoL for responders vs non-responders over time up to week 72. Bylvay Provides Durable Treatment Benefits (poster #1197). In this pooled analysis of data from the PEDFIC studies, Bylvay provided durable clinical treatment benefits in patients with PFIC who received treatment for at least 72 weeks, with mean improvements over time in sBA levels, pruritus, hepatic parameters and growth. Bylvay was generally well tolerated during = 72 weeks of treatment. Among the subgroup of patients treated with Bylvay for =72 weeks, 96% had a TEAE and 52% experienced drug-related TEAEs. The most common TEAEs were pyrexia, upper respiratory tract infection, and diarrhea. Improvements in Pruritus on Bylvay Lead to Improvements in Quality of Life, Hepatic Biomarkers, and Sleep (poster #865). Results of pooled analysis population of 82 patients treated with Bylvay including 44 pruritus responders of PEDFIC 1 and PEDFIC 2 show that patients across various types of PFIC who had a pruritus response with Bylvay experienced improvements in quality of life, sleep and hepatic biomarkers that were sustained for up to 72 weeks. From baseline to week 72, pruritus responders had significant quality of life improvements, as assessed by mean PEDsQL total scores (p=0.048) and PEDsQL FI total scores (p=0.007). Data also indicated that pruritus responders had significant improvements in several caregiver-reported sleep parameters (all P<0.001), including reductions in days with blood due to scratching, days needing help falling asleep, days needing soothing, and days sleeping with caregiver. Among all pruritus responders, 86% had any TEAE, none of which were drug related serious TEAEs.? Two patients experienced TEAEs that led to study discontinuation, which included splenomegaly, diarrhoea, jaundice, decreased weight, and/or hypophagia?. Bylvay Treatment Impacts Hepatic Parameters, Growth, Sleep, and Biochemical Markers Across PFIC Types (poster #850). Patients with across various types of PFIC treated with Bylvay for up to 72 weeks, with some tracked up to 128 weeks, experienced reductions in autotaxin levels and increases in C4 levels, as well as variable changes in hepatic parameters, sleep characteristics and growth. 84 patients received Bylvay during the pooled analysis period. Patients of almost all PFIC types experienced mean improvements in caregiver-reported sleep parameters. Patients of most PFIC types generally had mean increases in height and/or weight Z scores with Bylvay treatment; patients with PFIC1 and PFIC3 experienced more variable changes in weight Z scores. Among all patients, 85% had any TEAE, which was similar across all PFIC types and mild or moderate in severity?. All serious TEAEs were assessed as unrelated to study drug.

Albireo Pharma, Inc. Presents at William Blair’s 42nd Annual Growth Stock Conference 2022, Jun-07-2022 09:00 AM

2022-06-02 20:30:00

Albireo Pharma, Inc. Presents at William Blair’s 42nd Annual Growth Stock Conference 2022, Jun-07-2022 09:00 AM. Venue: Loews Chicago Hotel, Chicago, Illinois, United States. Speakers: Ronald H. W. Cooper, CEO, President & Director.

Albireo Pharma, Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 10:00 AM

2022-06-02 20:30:00

Albireo Pharma, Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 10:00 AM. Venue: Marriott Marquis, New York City, New York, United States. Speakers: Ronald H. W. Cooper, CEO, President & Director.

Albireo Pharma, Inc. Presents at H.C. Wainwright Global Investment Conference 2022, May-25-2022 09:00 AM

2022-05-19 20:30:00

Albireo Pharma, Inc. Presents at H.C. Wainwright Global Investment Conference 2022, May-25-2022 09:00 AM. Venue: Fontainebleau Miami Beach Hotel, 4441 Collins Avenue, Miami Beach, Florida, United States. Speakers: Pamela Stephenson, Chief Commercial Officer, Simon Nicolas Reade Harford, CFO & Treasurer.

Albireo Pharma, Inc. Provides Sales Guidance for the Year 2022

2022-05-16 20:01:00

Albireo Pharma, Inc. provided sales guidance for the year 2022. Bylvay 2022 sales are expected to be a minimum of $30 million.

Albireo Pharma, Inc., Q1 2022 Earnings Call, May 16, 2022

2022-05-09 12:30:00

Albireo Pharma, Inc., Q1 2022 Earnings Call, May 16, 2022

Albireo Pharma, Inc. to Report Q1, 2022 Results on May 16, 2022

2022-05-09 00:00:00

Albireo Pharma, Inc. announced that they will report Q1, 2022 results on May 16, 2022

Albireo Pharma, Inc. - Shareholder/Analyst Call

2022-04-21 12:00:00

AGM

Albireo Pharma, Inc., Annual General Meeting, Jun 16, 2022

2022-04-21 12:00:00

Albireo Pharma, Inc., Annual General Meeting, Jun 16, 2022, at 08:30 US Eastern Standard Time. Agenda: To elect two Class III directors to serve three-year terms expiring in 2025; to ratify the appointment of Ernst & Young LLP as company's independent registered public accounting firm for the fiscal year ending December 31, 2022; and to transact such other business as may be properly presented at the annual meeting or any adjournment or postponement thereof.

The European Association for the Study of the Liver, the International Liver Congress 2022, Jun 22, 2022 through Jun 25, 2022

2022-03-30 21:14:00

The European Association for the Study of the Liver, The International Liver Congress 2022, Jun 22, 2022 through Jun 25, 2022. Venue: London, United Kingdom.

Albireo Completes Enrollment in Pivotal Phase 3 ASSERT Study of BylvayTM (odevixibat) in Alagille Syndrome

2022-03-29 12:30:00

Albireo Pharma, Inc. announced the completion of patient enrollment in the ASSERT study, a Phase 3 pivotal trial of Bylvay (odevixibat) in patients with Alagille syndrome (ALGS). Topline results are expected to be available by the end of the year, consistent with guidance, and with the enrollment of 52 patients versus an original target of 45. ASSERT is a gold standard, global, double-blind, randomized, placebo-controlled trial designed to evaluate the safety and efficacy of Bylvay in patients with ALGS over 24 weeks. Both the U.S. FDA and EMA have agreed on the Phase 3 study design and have indicated that this single study would be sufficient for regulatory filings. Bylvay is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) already approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC, and in Europe for the treatment of all types of PFIC in patients aged 6 months or older. ALGS is a rare, multisystem genetic disorder that can affect the liver, heart, skeleton, eyes, central nervous system, kidneys and facial features. Liver damage is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first three months of life, and as many as 88% also present with severe, intractable pruritus. Aligned to the Company’s mission of providing hope for families, Albireo continues to prioritize access and continued scientific research for patients living with rare cholestatic liver diseases. Albireo opened an Expanded Access Program (EAP) with the first patient already enrolled. The program is available in the U.S. and Europe, which aims to provide access to Bylvay for patients suffering from ALGS, prior to the product’s planned approval and reimbursement. Timing of availability in Europe will vary due to country-specific regulations and stock availability. This program is available for patients with a clinical diagnosis of ALGS who have no other therapeutic options. The Company continues to enroll and dose patients in the Phase 3 BOLD study, which is the first and only pivotal trial of an IBATi in biliary atresia, that passed the 50% enrollment milestone and remains on track for topline data in 2024. Biliary atresia is the most common pediatric cholestatic liver disease with no approved drug treatment.

Albireo Pharma, Inc. Presents at Lytham Partners Spring 2022 Investor Conference, Apr-04-2022 11:00 AM

2022-03-29 02:59:00

Albireo Pharma, Inc. Presents at Lytham Partners Spring 2022 Investor Conference, Apr-04-2022 11:00 AM. Speakers: Christine Clemson, SVP, Head of Global Medical Affairs, Pamela Stephenson, Chief Commercial Officer.

H.C. Wainwright & Co., LLC, H.C. Wainwright Global Investment Conference 2022, May 23, 2022 through May 26, 2022

2022-02-28 18:21:00

H.C. Wainwright & Co., LLC, H.C. Wainwright Global Investment Conference 2022, May 23, 2022 through May 26, 2022. Venue: Fontainebleau Miami Beach Hotel, 4441 Collins Avenue, Miami Beach, Florida, United States.

Lytham Partners, LLC, Lytham Partners Spring 2022 Investor Conference, Apr 04, 2022 through Apr 07, 2022

2022-02-28 17:53:00

Lytham Partners, LLC, Lytham Partners Spring 2022 Investor Conference, Apr 04, 2022 through Apr 07, 2022.

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.

William Blair & Company, L.L.C., William Blair’s 42nd Annual Growth Stock Conference 2022, Jun 06, 2022 through Jun 09, 2022

2022-01-25 11:00:00

William Blair & Company, L.L.C., William Blair’s 42nd Annual Growth Stock Conference 2022, Jun 06, 2022 through Jun 09, 2022. Venue: Loews Chicago Hotel, Chicago, Illinois, United States.

Albireo Pharma, Inc. Presents at LifeSci Partners 11th Annual Corporate Access Event (virtual), Jan-05-2022

2021-12-16 17:17:00

Albireo Pharma, Inc. Presents at LifeSci Partners 11th Annual Corporate Access Event (virtual), Jan-05-2022 .

Albireo Announces Positive Topline Data from Phase 1 Study of A3907

2021-12-16 13:30:00

Albireo Pharma, Inc. announced positive topline results from its Phase 1 clinical trial of A3907, the first oral systemic apical sodium-dependent bile acid transporter (ASBT) inhibitor. The study achieved both primary and secondary objectives. Phase 1 study is a first-in-human, double-blind, single and multiple ascending dose study in healthy adult subjects to investigate the safety, tolerability, pharmacokinetics of orally administered A3907. A3907 was safe and well tolerated in this study at systemic exposures that demonstrated therapeutic benefits in preclinical models. With the potential to inhibit ileal, renal and hepatic ASBT, A3907 could provide the optimal balance of efficacy and tolerability in patients in multiple liver diseases. The study met its primary objectives with data showing A3907 overall to be safe and well tolerated, with no serious adverse events (SAEs) or discontinuations due to treatment emergent adverse events (TEAEs). All TEAEs were mild, the most common were mainly abdominal symptoms such as loose stools, and all participants finished the trial protocol. No clinically significant effects in clinical chemistry, hematology, physical examinations or ECG. The study also met its secondary objectives with dose-related plasma exposure up to 81 mg dose, with no accumulation. Exposure levels were within the range that show effects in animal disease models. Single doses of A3907 showed dose proportional increases in plasma exposure up to 81 mg with no further increase at a dose of 162 mg. The study showed target engagement with 7alpha-hydroxy-4-cholesten-3-one (C4) increases and low-density lipoprotein cholesterol (LDL-C) reductions, with C4 increases indicating elevation in bile acid excretion, while LDL-C reduction indicating elevated synthesis of bile acids from cholesterol. The Phase 1 trial was a randomized, double-blind, placebo-controlled, single and seven day multiple-dose study was conducted in 54 and 22, respectively, healthy subjects. Doses evaluated were 1-162 mg in the single ascending dose portion, and 9-67.5 mg in the multiple ascending dose portion. Primary objectives were safety and tolerability, secondary objectives were evaluation of pharmacokinetics, and there were multiple exploratory endpoints.

Albireo Pharma, Inc. Presenting New Bylvay™ (Odevixibat) Data at NASPGHAN 2021

2021-12-13 13:30:00

Albireo Pharma, Inc. will be presenting five posters on Bylvay (odevixibat) at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) meeting being held December 12–18. Data will be presented that show evidence of correlations in serum bile acid reductions and long-term improvements in pruritus and sleep in patients with progressive familial intrahepatic cholestasis (PFIC); reductions in serum bile acids and improvements in pruritus with and without concomitant ursodeoxycholic acid (UDCA) and/or rifampicin use; and the efficacy and safety of Bylvay in patients with PFIC and prior partial external biliary diversion (PEBD). Data on disease burden and natural history of PFIC will be presented to describe the clinical characteristics of the disease. There will also be a poster presentation on the Phase 3 double-blind, randomized, placebo-controlled ASSERT study of Bylvay in Alagille syndrome (ALGS). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi) that is approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC and in Europe for the treatment of all types of PFIC in patients aged 6 months or older. PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids (sBAs) in a randomized, double-blind, placebo-controlled trial, and PEDFIC 2 is a long-term, open-label Phase 3 extension study. Bylvay is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC). The European Commission (EC) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) have also granted marketing authorization of Bylvay for the treatment of PFIC in patients aged 6 months or older. Bylvay is available for sale in Germany and will be available for sale in other European countries following pricing and reimbursement approval. A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay acts locally in the small intestine. Bylvay can be taken as a capsule for patients that are able to swallow capsules, or opened and sprinkled onto food, which is a factor of key importance for adherence in a pediatric patient population. The medicine can only be obtained with a prescription.

Albireo Pharma, Inc. Announces Executive Changes

2021-12-09 14:00:00

Albireo Pharma, Inc. announced the upcoming departure of Pat Horn, M.D., Ph.D., Chief Medical Officer, who will be leaving at the end of the year 2021 after almost three and a half years with the company. Jan Mattsson, Ph.D., Chief Scientific Officer and co-founder of the company, will be taking over as the interim head of R&D, leading research and development of early and late-stage assets and programs. As one of the co-founders of the company with deep experience in drug development and approvals, Dr. Mattsson is primed to lead the R&D organization with his institutional knowledge, vision for the pipeline and products, and ability to deliver against corporate objectives.

Albireo Pharma, Inc. Announces Constantine Chinoporos as Chief Business Officer

2021-12-02 13:30:00

Albireo Pharma, Inc. announced the appointment of Constantine Chinoporos as Chief Business Officer and a member of the Albireo Enterprise Leadership Team. Mr. Chinoporos was most recently at Boston Pharmaceuticals where he was the Chief Business Officer responsible for all business development, new product planning operations and in-licensing of 20 programs over his tenure.

Albireo Pharma, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Nov-29-2021

2021-11-22 15:06:00

Albireo Pharma, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Nov-29-2021 . Venue: New York, New York, United States.

LifeSci Partners, LifeSci Partners 11th Annual Corporate Access Event (virtual), Jan 05, 2022 through Jan 07, 2022

2021-11-20 00:00:00

LifeSci Partners, LifeSci Partners 11th Annual Corporate Access Event (virtual), Jan 05, 2022 through Jan 07, 2022.

Albireo Announces New Phase 3 Data for Bylvay™ (Odevixibat) in Pfic and First Reveal of New Next Generation Bile Acid Modulator Data At Aasld the Liver Meeting® 2021

2021-11-12 13:00:00

Albireo Pharma, Inc. announced new data from the Phase 3 PEDFIC 1 study and PEDFIC 2 long-term extension study of Albireo’s product, Bylvay (odevixibat), and first data from preclinical studies of cholestatic and viral disease product candidate, A2342. The data demonstrate evidence of long-term treatment benefits of Bylvay based on improved liver health and function across progressive familial intrahepatic cholestasis (PFIC) types that reduce the disease burden in the treatment of pruritus in PFIC. In addition, the company will showcase the first data from A2342 showing potential of sodium-taurocholate co-transporting peptide (NTCP) inhibition in viral and cholestatic liver diseases. The data will be presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2021, which is being held virtually November 12 – 15. The Company will present data on Bylvay in one oral presentation and four posters. Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi) that is approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of PFIC and in Europe for the treatment of all types of PFIC in patients aged 6 months or older. PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids in a randomized, double-blind, placebo-controlled trial, and PEDFIC 2 is a long-term, open-label Phase 3 extension study. The observed safety and tolerability profile of Bylvay was consistent across studies, treatment groups and doses, regardless of PFIC classification or BSEP subtype. No drug-related serious adverse events were reported in either PEDFIC 1 or PEDFIC 2. Treatment-related diarrhea/frequent bowel movements reported in 9.5% of Bylvay treated patients in PEDFIC 1 and 5% of placebo-treated patients. Individual abstracts present data for specific safety and tolerability. The Company will also present data from its preclinical studies of A2342, the first oral NTCP inhibitor in development for viral and cholestatic liver diseases. IND-enabling studies for A2342 are currently being completed. Data to be presented is from studies on the impact of A2342 in models of in vitro and in vivo hepatitis B virus (HBV) infection and in animal models demonstrating NTCP target engagement.

Albireo Pharma, Inc. Presents at 12th Annual Jefferies Global Healthcare Conference, Nov-17-2021 06:20 AM

2021-11-10 13:31:00

Albireo Pharma, Inc. Presents at 12th Annual Jefferies Global Healthcare Conference, Nov-17-2021 06:20 AM. Venue: London, United Kingdom. Speakers: Ronald H. W. Cooper, CEO, President & Director, Simon Nicolas Reade Harford, CFO & Treasurer.

Albireo Pharma, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov-22-2021 10:00 AM

2021-11-10 13:30:00

Albireo Pharma, Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov-22-2021 10:00 AM. Speakers: Ronald H. W. Cooper, CEO, President & Director, Simon Nicolas Reade Harford, CFO & Treasurer.

Albireo Pharma, Inc., Q3 2021 Earnings Call, Nov 04, 2021

2021-10-28 12:30:00

Albireo Pharma, Inc., Q3 2021 Earnings Call, Nov 04, 2021

Albireo Pharma, Inc. to Report Q3, 2021 Results on Nov 04, 2021

2021-10-28 12:30:00

Albireo Pharma, Inc. announced that they will report Q3, 2021 results on Nov 04, 2021

Piper Sandler Companies, Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov 22, 2021

2021-10-25 10:00:00

Piper Sandler Companies, Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov 22, 2021.

Albireo Pharma, Inc. - Special Call

2021-10-15 12:30:00

To discuss the data from the Phase 3 PEDFIC 1 study and PEDFIC 2 long-term extension study of Albireo’s product, Bylvay (odevixibat), and data from studies of viral disease product candidate, A2342

Albireo Pharma, Inc. Announces Exclusive Licensing Agreement with Jadeite Medicines for Bylvay™ (Odevixibat) in Japan

2021-10-12 12:30:00

Albireo Pharma, Inc. entered into an exclusive licensing agreement with Jadeite Medicines, Inc. for the development and commercialization of Bylvay (odevixibat) in Japan for progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS) and biliary atresia. Under the terms of the agreement, Albireo will receive an upfront payment of $15M and will be eligible to receive up to $120M in milestones as well as double-digit royalties. Jadeite Medicines, a biopharmaceutical platform company focused on developing global innovative pharmaceutical products for Japan, will be responsible for clinical development, regulatory approval and commercialization of Bylvay in Japan, where there is significant market opportunity. Bylvay is the first drug approved in Europe for the treatment of all types of PFIC and in the U.S. for the treatment of pruritus in all types of PFIC. A potent, non-systemic ileal bile acid transport inhibitor (IBATi), Bylvay is administered as a once-daily capsule or opened and sprinkled onto soft foods. Bylvay is currently being evaluated in the ASSERT Phase 3 study for ALGS, the BOLD Phase 3 study for patients with biliary atresia and the ongoing PEDFIC 2 open-label trial in patients with PFIC.

Albireo Pharma, Inc. Announces Bylvay® (Odevixibat) Now Available in Germany

2021-09-15 12:30:00

Albireo Pharma, Inc. announced that Bylvay (odevixibat), the first drug approved in Europe for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC), is now available by prescription to patients in Germany. Bylvay is also approved in the U.S. for the treatment of pruritus in all types of PFIC. A potent, non-systemic ileal bile acid transport inhibitor (IBATi), Bylvay is administered as a once-daily capsule or opened and sprinkled onto soft foods and does not require refrigeration. Bylvay is now available through retail pharmacies. Sales promotion has already begun, with Albireo commercial staff covering the key centers to inform them of the availability of Bylvay for the treatment of PFIC and the patient support services available. Once Bylvay is prescribed, healthcare providers and families will have the option to use Albireo Assist®, which is a customized patient support program built with input from medical experts and patient advocates that aims to support patients and caregivers throughout their treatment journey. To support payor decision-making, Albireo has submitted a value dossier to the Joint Federal Committee (G-BA) in Germany with the PEDFIC 1 and PEDFIC 2 Phase 3 data, including long-term data with patients on drug for over two years; natural history information; and a caregiver study to reflect the burden of PFIC. This submission commences the drug benefit assessment process. General national reimbursement will be granted throughout the entire process as well as thereafter. Albireo has launched Bylvay in the U.S. and is working to commercialize Bylvay in other European countries. Bylvay is currently being evaluated by a number of reimbursement agencies in Europe. Albireo is working closely with all relevant agencies to ensure access for patients in Europe as quickly as possible. Bylvay is currently being evaluated in the ongoing PEDFIC 2 open-label trial in patients with PFIC, ASSERT Phase 3 study for Alagille syndrome and in the BOLD Phase 3 study for patients with biliary atresia. The ASSERT and BOLD studies remain on track to report topline data in 2022 and 2024 respectively.

Albireo Pharma, Inc. Receives UK MHRA Approval of Bylvay® (odevixibat)

2021-09-08 12:30:00

Albireo Pharma, Inc. announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Bylvay (odevixibat) for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi), administered as a once-daily capsule or opened and sprinkled onto soft foods and which does not require refrigeration. The MHRA authorization follows the European Commission (EC) authorization of Bylvay in July 2021. The MHRA authorization was based on data from PEDFIC 1 and PEDFIC 2, the largest, global, Phase 3 trials ever conducted in PFIC. In PEDFIC 1, a randomized, double-blind, placebo-controlled study, Bylvay met both its pruritus (p=0.004) and serum bile acid (p=0.003) primary endpoints and was well tolerated with low incidence of drug-related diarrhea/frequent bowel movements (9.5% of treated patients vs. 5.0% of placebo patients). PEDFIC 2, a long-term, open-label Phase 3 extension study, affirmed Bylvay delivered sustained reductions in serum bile acid as well as improvements in pruritus assessments, growth and markers of liver function in patients treated up to 48 weeks in an interim analysis. Across both studies, Bylvay was well tolerated with diarrhea/frequent stools being the most common treatment-related gastrointestinal adverse events. There were no serious treatment-related adverse events reported in any clinical study with Bylvay. Albireo has launched Bylvay in the U.S. and is working to commercialize Bylvay in Europe. Bylvay is currently being evaluated by NICE under the Highly Specialised Technologies (HST) pathway, and Albireo is working closely with NICE and NHS England to ensure access for patients in England and Wales as quickly as possible. The Company is also actively engaging with the Scottish Medicines Consortium (SMC). Albireo has developed a compelling value package with the PEDFIC gold standard Phase 3 data, natural history information and data from a recent study reflecting the burden of PFIC on caregivers and families. Bylvay is currently being evaluated in the ongoing PEDFIC 2 open-label trial in patients with PFIC, ASSERT Phase 3 study for Alagille syndrome and in the BOLD Phase 3 study for patients with biliary atresia. The ASSERT and BOLD studies remain on track to report topline data in 2022 and 2024 respectively.

Albireo Pharma, Inc. Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-13-2021 07:00 AM

2021-09-02 12:30:00

Albireo Pharma, Inc. Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-13-2021 07:00 AM. Venue: Lotte New York Palace Hotel, New York City, New York, United States. Speakers: Ronald H. W. Cooper, CEO, President & Director, Simon Nicolas Reade Harford, CFO & Treasurer.

Albireo Pharma, Inc. Presents at Baird Global Healthcare Conference 2021, Sep-14-2021 09:40 AM

2021-08-26 17:20:00

Albireo Pharma, Inc. Presents at Baird Global Healthcare Conference 2021, Sep-14-2021 09:40 AM. Speakers: Ronald H. W. Cooper, CEO, President & Director, Simon Nicolas Reade Harford, CFO & Treasurer.

Robert W. Baird & Co. Incorporated, Baird Global Healthcare Conference 2021, Sep 14, 2021 through Sep 15, 2021

2021-08-10 13:03:00

Robert W. Baird & Co. Incorporated, Baird Global Healthcare Conference 2021, Sep 14, 2021 through Sep 15, 2021.

Albireo Pharma, Inc. Presents at 12th Annual Wedbush PacGrow Healthcare Virtual Conference, Aug-10-2021 03:30 PM

2021-08-03 12:30:00

Albireo Pharma, Inc. Presents at 12th Annual Wedbush PacGrow Healthcare Virtual Conference, Aug-10-2021 03:30 PM. Speakers: Ronald H. W. Cooper, CEO, President & Director, Simon Nicolas Reade Harford, CFO & Treasurer.

Albireo Pharma, Inc. to Report Q2, 2021 Results on Aug 05, 2021

2021-07-29 12:32:00

Albireo Pharma, Inc. announced that they will report Q2, 2021 results on Aug 05, 2021

Albireo Pharma, Inc., Q2 2021 Earnings Call, Aug 05, 2021

2021-07-29 12:30:00

Albireo Pharma, Inc., Q2 2021 Earnings Call, Aug 05, 2021

Albireo Pharma, Inc. Presents at Wells Fargo 2021 Virtual Healthcare Conference, Sep-09-2021 09:20 AM

2021-07-22 14:24:00

Albireo Pharma, Inc. Presents at Wells Fargo 2021 Virtual Healthcare Conference, Sep-09-2021 09:20 AM. Speakers: Christine Clemson, VP, Medical Affairs, Joanna Opalinski, Executive Assistant, Pamela Stephenson, Chief Commercial Officer, Ronald H. W. Cooper, CEO, President & Director, Simon Nicolas Reade Harford, CFO & Treasurer.

Wells Fargo Securities, LLC, Wells Fargo 2021 Virtual Healthcare Conference, Sep 09, 2021 through Sep 10, 2021

2021-07-22 09:08:00

Wells Fargo Securities, LLC, Wells Fargo 2021 Virtual Healthcare Conference, Sep 09, 2021 through Sep 10, 2021.

Albireo Pharma, Inc. - Special Call

2021-07-20 21:25:00

To discuss about the FDA Approval of Bylvay(TM) (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

Albireo Pharma, Inc. Announces FDA Approval of Bylvay™, the First Drug Treatment for Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)

2021-07-20 20:00:00

Albireo Pharma, Inc. announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi), which does not require refrigeration and is easily administered as a once-daily capsule or opened and sprinkled onto soft foods. Albireo is launching Bylvay immediately to accelerate availability for the patients and families impacted by PFIC. PFIC is a rare and devastating disorder affecting young children that causes progressive, life-threatening liver disease. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life. The most prominent and problematic ongoing manifestation of PFIC is pruritus, or intense itching, which often results in a severely diminished quality of life. Until now, there have been no approved drugs for PFIC. Only surgical options that include biliary diversion surgery (BDS) and liver transplantation have been available, and without them, most PFIC patients do not survive past the age of 30. There are an estimated 100,000 patients with cholestatic liver disease without an approved drug treatment. Of those patients, there are approximately 15,000 with PFIC (excluding China and India). The approval of Bylvay was supported by data from PEDFIC 1 and PEDFIC 2, the largest, global, Phase 3 trials ever conducted in PFIC. In PEDFIC 1, a randomized, double-blind, placebo-controlled study, Bylvay met both its pruritus (p=0.004) and serum bile acid (p=0.003) primary endpoints and was well tolerated with very low incidence of diarrhea/frequent bowel movements (9.5% of treated patients vs. 5.0% of placebo patients). PEDFIC 2, a long-term, open-label Phase 3 extension study, reaffirmed Bylvay delivered sustained reductions in serum bile acids as well as improvements in pruritus assessments, growth and other markers of liver function in patients treated up to 48 weeks. Across both studies, Bylvay was well tolerated with diarrhea/frequent stools being the most common treatment-related gastrointestinal adverse events. There were no serious treatment-related adverse events.

Albireo Pharma, Inc. Announces European Commission Authorization of Bylvay (Odevixibat), the First Drug Approved for the Treatment of All Subtypes of Progressive Familial Intrahepatic Cholestasis

2021-07-19 12:01:00

Albireo Pharma, Inc. announced European Commission authorization of Bylvay (odevixibat), the first drug approved for the treatment of all subtypes of progressive familial intrahepatic cholestasis (PFIC). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi), which does not require refrigeration and is easily administered as a once-daily capsule or opened and sprinkled onto soft foods. PFIC is a rare and devastating disorder affecting young children that causes progressive, life-threatening liver disease. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life. The most prominent and problematic ongoing manifestation of PFIC is pruritus, or intense itching, which often results in a severely diminished quality of life. Until now, there have been no approved drugs for PFIC; only surgical options that include biliary diversion surgery (BDS) and liver transplantation, and without them most PFIC patients do not survive past the age of 30. Of the estimated 100,000 patients with cholestatic liver disease worldwide without an approved drug treatment, there are approximately 15,000 PFIC patients, excluding China and India. The EC authorization was based on data from PEDFIC 1 and PEDFIC 2, the largest, global, Phase 3 trials ever conducted in PFIC. In PEDFIC 1, a randomized, double-blind, placebo-controlled study, Bylvay met both its pruritus (p=0.004) and serum bile acid (p=0.003) primary endpoints and was well tolerated with very low incidence of drug-related diarrhea/frequent bowel movements (9.5% of treated patients vs. 5.0% of placebo patients). PEDFIC 2, a long-term, open-label Phase 3 extension study, affirmed Bylvay delivered sustained reductions in serum bile acid as well as improvements in pruritus assessments, growth and other markers of liver function in patients treated up to 48 weeks in an interim analysis. Across both studies, Bylvay was well tolerated with diarrhea/frequent stools being the most common treatment-related gastrointestinal adverse events. There were no serious treatment-related adverse events reported in any clinical study with Bylvay. Albireo plans to directly commercialize Bylvay in the European Union (EU) and is prepared for a global launch with commercial, market access and medical affairs personnel already on the ground. This includes Germany, which has the largest EU market potential, with launch planned for September 2021, following price listing. Pricing and reimbursement dossiers have been submitted to many member states to provide access to Bylvay treatment as soon as possible. Albireo has developed a compelling value package with the PEDFIC gold standard Phase 3 data, natural history information and data from a recent study reflecting the burden of PFIC on caregivers and families. The Company also anticipates an upcoming regulatory decision by the U.S. FDA on Bylvay for the treatment of pruritus in patients with PFIC. The FDA has granted a Priority Review for the NDA and has set an action date of July 20, 2021 under the Prescription Drug User Fee Act (PDUFA). Albireo is also studying the use of Bylvay in other rare pediatric cholestatic diseases with the BOLD Phase 3 clinical trial in patients with biliary atresia and the ASSERT Phase 3 clinical trial in Alagille syndrome. Topline data from the ASSERT trial is expected in 2022, and data from the BOLD trial is expected in 2024. Bylvay is the first drug treatment approved in the world for the treatment of all subtypes of progressive familial intrahepatic cholestasis (PFIC). A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay acts locally in the small intestine. Bylvay does not require refrigeration and can be taken as a capsule for older children, or opened and sprinkled onto food, which are factors of key importance for adherence in a pediatric patient population. Bylvay has an Orphan Designation for the treatment of PFIC. The EMA’s Pediatric Committee has agreed to Albireo’s Bylvay Pediatric Investigation Plans for PFIC, biliary atresia, and Alagille syndrome. In addition to PFIC, Bylvay has Orphan Designations for the treatment of Alagille syndrome, biliary atresia and primary biliary cholangitis. Bylvay is available as capsules. The recommended dose is 40 microgram per kilogram body weight. The capsules should be taken once a day in the morning. They can be taken whole, or they can be opened and sprinkled on food. If the clinical response is inadequate after three months, the dose may be increased up to 120 microgram per kilogram body weight. The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor, who has experience in the management of PFIC.

Albireo Pharma, Inc. Presents at William Blair Biotech Focus Conference 2021, Jul-15-2021 11:00 AM

2021-07-07 09:33:00

Albireo Pharma, Inc. Presents at William Blair Biotech Focus Conference 2021, Jul-15-2021 11:00 AM. Speakers: Ronald H. W. Cooper, CEO, President & Director.

Wedbush Securities Inc., 12th Annual Wedbush PacGrow Healthcare Virtual Conference, Aug 10, 2021 through Aug 11, 2021

2021-06-29 20:28:00

Wedbush Securities Inc., 12th Annual Wedbush PacGrow Healthcare Virtual Conference, Aug 10, 2021 through Aug 11, 2021.