$ALBO News

Last published 3y ago

3y agoALBOFDA Grants June 15, 2023 PDUFA Date to Albireo for Bylvay® in Alagille SyndromeGlobeNewswireBylvay (odevixibat) granted Priority Review by U.S. FDAASSERT study demonstrated efficacy of Bylvay in pruritus, bile acids and sleep with a low drug-related diarrhea rate in Alagille patientsApproval in second
3y agoALBO ALR CEMI LPTXMoore Kuehn Encourages ALBO, LPTX, ALR, and CEMI Investors to Contact Law FirmGlobeNewswireNEW YORK, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Moore Kuehn, PLLC, a law firm focusing in securities litigation located on Wall Street in downtown New York City, is investigating potential claims concerning whether the
3y agoALBO CINC GMGI PAYAMoore Kuehn Encourages GMGI, CINC, ALBO, and PAYA Investors to Contact Law FirmGlobeNewswireNEW YORK, Jan. 25, 2023 (GLOBE NEWSWIRE) -- Moore Kuehn, PLLC, a law firm focusing in securities litigation located on Wall Street in downtown New York City, is investigating potential claims concerning whether the
3y agoALBO CINC GMGI PAYAMoore Kuehn Encourages GMGI, CINC, ALBO, and PAYA Investors to Contact Law FirmPR NewswireNEW YORK, Jan. 22, 2023 /PRNewswire/ -- Moore Kuehn, PLLC, a law firm focusing in securities litigation located on Wall Street in downtown New York City, is investigating potential claims concerning whether the following
3y agoALBOAlbireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Dec. 20, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the grant to
3y agoALBOAlbireo Submits Bylvay® Alagille Syndrome Regulatory Filings to FDA and EMAGlobeNewswire- Gold standard Phase 3 ASSERT study supports supplementary filings in the U.S. and EU - ASSERT study demonstrated efficacy of Bylvay (odevixibat) in pruritus, bile acids and sleep with a low drug-related diarrhea rate
3y agoALBOAlbireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the grant of
3y agoALBOAlbireo Appoints Paul Streck, M.D., as Chief Medical Officer & Craig Hopkinson, M.D., to Board of DirectorsGlobeNewswire– Dr. Craig Hopkinson, currently EVP of Research & Development and Chief Medical Officer at Alkermes, brings strong global orphan drug development expertise – Dr. Paul Streck, former Chief Medical Officer at Arena
4y agoALBOAlbireo to Participate in Jefferies London Healthcare ConferenceGlobeNewswireBOSTON, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced participation in
4y agoALBOAlbireo Reports Q3 2022 Financial Results and Business UpdateGlobeNewswireBylvay® (odevixibat) Q3 2022 PFIC net revenue of $7.5 million, September YTD 2022 $18.1 millionNew disease modification and native liver survival data with Bylvay in PFIC patients presented at AASLD Positive Bylvay
4y agoALBOBylvay® (odevixibat) Data Presented at AASLD The Liver Meeting® 2022, Demonstrating Native Liver Survival in Children Across PFIC TypesGlobeNewswireEarly, rapid, and sustained efficacy across wide range of patients with evidence of disease modificationLong-term preservation of native liver in PFIC, improvements in pruritus, bile acids, and increased growth over
4y agoALBOAlbireo Announces 2022 SPARK Grant WinnersGlobeNewswire— Eight projects selected for inaugural year of the program — Projects provide solutions to make a tangible difference in the lives of PFIC patients BOSTON, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Albireo
4y agoALBOAlbireo Completes Phase 3 BOLD Study Enrollment of Bylvay(R) in Biliary AtresiaGlobeNewswire– BOLD is the first, largest, and only global Phase 3 trial designed to meet regulatory agencies' requirements – On track to report topline data by the end of 2024, reinforcing Bylvay's expected position as
4y agoALBOAlbireo to Present Late Breaking Bylvay® (odevixibat) Data at AASLD 2022GlobeNewswire– Oral late breaker with new results from positive Phase 3 ASSERT study in Alagille syndrome (ALGS) – Oral late breaker provides evidence of disease modification in PFIC – Analysis of PEDFIC 1 data showed
4y agoALBOAlbireo to Report Q3 2022 Financial Results on November 8, 2022GlobeNewswireBOSTON, Oct. 31, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live
4y agoALBOAlbireo Presents Data on Greater Efficacy in PFIC with Earlier Bylvay® Treatment at NASPGHANGlobeNewswire– New data presented at the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition meeting (NASPGHAN) – Earlier treatment with Bylvay (odevixibat) provided greater efficacy in children with
4y agoALBOAlbireo to Participate in H.C. Wainwright 3rd Annual Hepatitis B Virus (HBV) ConferenceGlobeNewswireBOSTON, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced participation in
4y agoALBOAlbireo Reports Positive Topline Data from Phase 3 Trial of Bylvay® (odevixibat) in Alagille SyndromeGlobeNewswireHighly statistically significant improvement in pruritus primary endpoint (p=0.002)Significant reductions in key secondary endpoint of serum bile acid levels (p=0.001)Substantial improvements in multiple sleep
4y agoALBOAlbireo to Showcase New Data at AASLD The Liver Meeting® 2022GlobeNewswire– Seven abstracts accepted, including one oral presentation highlighting long-term data demonstrating Bylvay® (odevixibat) durable efficacy in patients with all types of PFIC – One abstract describes data on A3907, a systemic ASBT inhibitor, in d
4y agoALBOAlbireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Sept. 27, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the grant of inducement restricted stock units to a
4y agoALBOAlbireo Announces $115 Million Royalty Monetization Agreement with SagardGlobeNewswireUpfront payment for continued clinical development and commercialization of Bylvay® Sagard to receive a mid-single digit average royalty rate on Bylvay sales No liens against Bylvay intellectual property Right to buy out Sagard's investment at any
4y agoALBOAlbireo to Participate in Guggenheim Nantucket Therapeutics ConferenceGlobeNewswireBOSTON, Sept. 20, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced participation in the Guggenheim Therapeutics Confer
4y agoALBOItalian Medicines Agency Approves Reimbursed Access to Bylvay® (odevixibat) For Patients with All PFIC TypesGlobeNewswirePositive Agenzia Italiana del Farmaco (AIFA) decision provides reimbursed access to the first medicine available for the treatment of all types of PFIC, a rare and devastating disorder that affects young children and causes progressive, life-threatening
4y agoALBOAlbireo to Participate in Upcoming Investor ConferencesGlobeNewswireBOSTON, Sept. 01, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced participation in upcoming investor conference
4y agoALBOAlbireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, Aug. 22, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced the grant of inducement restricted stock units to acquire 17,300 shares of Albireo's commo
4y agoALBOAlbireo Reports Q2 2022 Financial Results and Business UpdateGlobeNewswireBylvay®(odevixibat) Q2 2022 net product revenue $5.9 million, June YTD 2022 $10.5 million Agreed Bylvay reimbursement contract in Italy and Belgium with launches planned for the fall Global Phase 3 ASSERT study in Alagille syndrome on track for topli
4y agoALBOAlbireo Appoints New Members to Board of DirectorsGlobeNewswire– Habib Dable, Former President and CEO of Acceleron Pharma, and Susan Alesina, Vice President, National Business Development and Alliances at Boston Children's Hospital, bring significant global drug development, financial and commercial operations ex
4y agoALBOAlbireo to Participate in 2022 Wedbush PacGrow Healthcare ConferenceGlobeNewswireBOSTON, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced participation in the 2022 Wedbush PacGrow Heal
4y agoALBOAlbireo to Report Q2 2022 Financial Results on August 15, 2022GlobeNewswireBOSTON, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on Au
4y agoALBOAlbireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswireBOSTON, July 26, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced the grant of inducement restricted stock units to acquire 16, 200 shares of Albireo's comm
4y agoALBOThe Lancet Gastroenterology & Hepatology Publishes Data from Albireo's Landmark PEDFIC 1 Study of Bylvay® (odevixibat) Treatment in PFICGlobeNewswireFirst successful global gold standard pediatric Phase 3 trial ever conducted in cholestatic liver disease PEDFIC 1 & 2 studies were foundational for the approval of Bylvay in the U.S. and Europe Study shows Bylvay provided statistically significant
4y agoALBOAlbireo to Present at the William Blair Biotech Focus Conference 2022GlobeNewswireBOSTON, June 30, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced participation at the William Blair Biotech Focus Conference July 12-13, 2022. Ron Cooper,
4y agoALBOAlbireo Presents New Bylvay® (odevixibat) Data at Annual ESPGHAN CongressGlobeNewswireFour presentations highlight newest data from landmark Phase 3 PEDFIC 1 and PEDFIC 2 trials, largest studies completed in PFIC New analysis show potential for greater response and higher proportion of pruritus responders with dose escalation and consis
4y agoALBOAlbireo Announces Presentation of New Data in Pediatric and Adult Liver DiseasesGlobeNewswireNew analyses of PEDFIC Phase 3 trials show that patients whose pruritus improves on Bylvay® (odevixibat) also experience improvements in sleep, quality of life, serum bile acids and hepatic parameters Long-term data from PEDFIC trials of Bylvay show
4y agoALBOAlbireo to Present New Data at the EASL International Liver Congress™ 2022GlobeNewswire– Five abstracts accepted, long-term data confirmed durable efficacy with Bylvay™ (odevixibat), with demonstrated improvement in quality of life, growth, and sleep measurements, and hepatic biomarkers in children with all types of PFIC – Two a
4y agoALBOAlbireo to Present New Data at the 54th Annual Meeting of ESPGHANGlobeNewswire– Four abstracts accepted of Phase 3 data from PEDFIC 1 and PEDFIC 2 trials of Bylvay™ (odevixibat) – Three oral presentations discuss long-term safety, tolerability and improved quality of life, hepatic biochemical markers, sleep in children wi
4y agoALBOAlbireo to Participate at Upcoming Investor ConferencesGlobeNewswireBOSTON, June 02, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced that Ron Cooper, President and Chief Executive Officer will be presenting at the following
4y agoALBOAlbireo Presented Data in Cholestatic Liver Diseases at Digestive Disease Week (DDW) 2022GlobeNewswire– Six abstracts presented highlighting data on BylvayTM (odevixibat) and effects on pruritus, serum bile acids, growth and sleep parameters – Pre-clinical study of systemic ASBT/NTCP inhibitors, shows potential of dual-acting ileal/kidney and li
4y agoALBOAlbireo to Participate in the H.C. Wainwright Global Investment Conference 2022GlobeNewswireBOSTON, May 19, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced participation in the H.C. Wainwright Global Life Science Conference May 23-26, 2022. Simon
4y agoALBOAlbireo Reports Q1 2022 Financial Results and Business UpdateGlobeNewswirePositive Bylvay™ (odevixibat) global commercial launch in U.S., Germany and United Kingdom with Q1 2022 product revenue, net $4.7 million Phase 3 ASSERT study in Alagille syndrome fully enrolled, patient numbers above original target and on trac
4y agoALBOAlbireo to Report Q1 2022 Financial Results on May 16GlobeNewswireBOSTON, May 09, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on May
4y agoALBOAlbireo Completes Enrollment in Pivotal Phase 3 ASSERT Study of BylvayTM (odevixibat) in Alagille SyndromeGlobeNewswire– Phase 3 ASSERT study on track to report topline data by the end of year – Albireo launches Expanded Access Program (EAP) for Alagille syndrome patients BOSTON, March 29, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare l
4y agoALBOAlbireo Reports Q4 and Year-End 2021 Financial Results and Business UpdateGlobeNewswireBylvay™ (odevixibat) launched in the U.S. and Europe, 2021 product revenue, net $7 million NICE endorses clinical and economic benefits of Bylvay Phase 3 study in Alagille syndrome on track for readout in 2022 Reports $248.1 million of cash and ca
4y agoALBONoema Pharma Appoints Michael Gutch as Chief Financial OfficerGlobeNewswireBASEL, Switzerland, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a Swiss-based clinical stage company targeting orphan central nervous system (CNS) diseases, today announces the appointment of Michael Gutch, Ph.D., as Chief Financial Officer. Dr. Gu
4y agoALBOAlbireo to Report Q4 and Year-End 2021 Financial Results on March 1GlobeNewswireBOSTON, Feb. 22, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live audio webcast at 10:00 a.m. ET on M
4y agoALBONICE Recommends Albireo's Bylvay® (odevixibat) for All PFIC TypesGlobeNewswire– Decision provides access to the first drug treatment approved in PFIC for patients in England, Wales and Northern Ireland – Positive NICE review completed in less than six months post MHRA approval – NICE review is first successful clinical
4y agoALBOAlbireo Announces Publication of the PICTURE Study Highlighting the Caregiver Impact of PFIC, a Rare and Devastating Children's Liver DiseaseGlobeNewswirePFIC caregivers reported high impact on mental and physical health, productivity, career prospects, sleep, relationships and finances Study suggests PFIC caregivers' quality of life may be comparable to that of cystic fibrosis caregivers BOSTON, F
4y agoALBOAlbireo Increases 2021 Bylvay™ (odevixibat) Sales GuidanceGlobeNewswire– Bylvay net sales guidance revised to $6-7M vs. expectations of $3-4M – Unaudited cash of at least $248M, updates guidance with cash into 2024 – BOLD Phase 3 study in biliary atresia is over 50% enrolled – ASSERT Phase 3 study in Alagil
4y agoALBOAlbireo Announces Positive Topline Data from Phase 1 Study of A3907GlobeNewswire– First oral, systemic ASBT inhibitor was safe and well tolerated – Secondary and exploratory objectives show favorable pharmacokinetics and systemic exposure, while providing target engagement signals – Company on track to initiate planned a
4y agoALBOAlbireo Presenting New Bylvay™ (odevixibat) Data at NASPGHAN 2021GlobeNewswire– Data show significant correlations in serum bile acid reductions and long-term improvements in pruritus and sleep – Reductions in serum bile acids and improvements in pruritus with and without concomitant ursodeoxycholic acid and/or rifampicin