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Albireo Pharma (Nasdaq: ALBO) announced that the U.S. FDA granted Priority Review for Bylvay (odevixibat) for the treatment of Alagille syndrome (ALGS), with a PDUFA action date of June 15, 2023. The ASSERT Phase 3 study demonstrated Bylvay's efficacy in reducing pruritus and bile acids while maintaining a low incidence of drug-related diarrhea among patients. Approval for this second indication could significantly expand Bylvay's market potential. Bylvay is already approved for treating pruritus in progressive familial intrahepatic cholestasis (PFIC) in the U.S. and EU, contributing to its growing accessibility for patients needing treatment options.
Ipsen has announced a definitive merger agreement to acquire Albireo for $42.00 per share, plus a contingent value right of $10.00 pertaining to potential FDA approval for Bylvay in biliary atresia. This acquisition aims to enhance Ipsen's Rare Disease portfolio, particularly through the inclusion of Bylvay®, the first approved treatment for progressive familial intrahepatic cholestasis (PFIC). The total consideration for the acquisition amounts to approximately $952 million. The transaction is expected to close by the end of Q1 2023.
Albireo Pharma announced the submission of a supplemental New Drug Application for Bylvay to treat Alagille syndrome (ALGS), following positive Phase 3 ASSERT study results. The study demonstrated significant efficacy in reducing pruritus and bile acids with a low rate of drug-related diarrhea. Approval is expected in the U.S. and EU in late 2023. Bylvay is currently approved for pruritus in progressive familial intrahepatic cholestasis (PFIC) patients. The company aims to broaden Bylvay’s access to the ALGS patient community, impacting approximately 25,000 individuals globally.
Albireo Pharma, Inc. (Nasdaq: ALBO) announced the grant of inducement restricted stock units for 13,700 shares of its common stock. This grant is part of the employee's acceptance of employment, aligning with Nasdaq Listing Rule 5635(c)(4). The restricted stock units will vest over four years, with 25% vesting on the first anniversary of employment and the remaining 75% vesting quarterly. Albireo continues to focus on developing novel bile acid modulators for pediatric and adult liver diseases, including the FDA-approved Bylvay for treating pruritus in progressive familial intrahepatic cholestasis.
Albireo Pharma has appointed Dr. Paul Streck as Chief Medical Officer and Dr. Craig Hopkinson to the Board of Directors, enhancing its leadership at a pivotal growth stage. Both leaders bring extensive drug development experience, aimed at broadening the indications of Bylvay and advancing new compounds for liver diseases. These appointments come as the company progresses towards significant clinical and commercialization milestones, indicating a strategic push into larger patient populations across pediatric cholestatic liver diseases.
Albireo Pharma (Nasdaq: ALBO) announced that Bylvay (odevixibat) has received reimbursed access in France for treating progressive familial intrahepatic cholestasis (PFIC) types 1 and 2. This follows a positive assessment from the Haute Autorité de Santé. Bylvay offers a non-surgical treatment option for children suffering from PFIC, potentially improving their quality of life. The drug's reimbursement in France is the sixth approval in Europe. Albireo plans further submissions for Bylvay's use in Alagille syndrome and reports topline data from the BOLD Phase 3 study in 2024.
Albireo Pharma (Nasdaq: ALBO) announced its participation in the Jefferies London Healthcare Conference from November 15-17, 2022. CFO Simon Harford will present on November 15 at 10:20 AM GMT. The event will be available for on-demand viewing on the Albireo Investors page.
Albireo focuses on developing novel bile acid modulators for treating pediatric and adult liver diseases. Its lead product, Bylvay, has FDA approval for treating pruritus associated with progressive familial intrahepatic cholestasis (PFIC) and is undergoing clinical trials for other rare liver diseases.
Albireo Pharma reported Q3 2022 net revenue of $7.5 million for Bylvay, totaling $18.1 million year-to-date. The company presented new data on disease modification and liver survival for Bylvay at AASLD. The Phase 3 ASSERT trial showed positive results in treating ALGS, with expected topline data from the BOLD study in biliary atresia planned for 2024. Albireo secured $115 million from a royalty monetization deal, strengthening its cash position to support ongoing programs.
Albireo Pharma (ALBO) reported positive results from its recent presentations at the Liver Meeting 2022. Data revealed Bylvay (odevixibat) demonstrated early, rapid, and sustained efficacy in patients with progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome (ALGS). Key highlights include evidence of disease modification and the restoration of bile acid secretion in PFIC patients. Both the PEDFIC and ASSERT trials received 'Best of Liver Meeting' honors. The findings are expected to improve patient outcomes and quality of life, marking a significant advancement in treating these rare diseases.
Albireo Pharma (ALBO) announced the winners of its inaugural SPARK grants program aimed at enhancing care for PFIC patients. The program received numerous innovative project submissions focused on improving standard care for rare liver diseases. Eight projects were awarded grants, including studies on disease progression and assessment tools for pediatric cholestatic liver diseases. Albireo's CEO emphasized the importance of such initiatives in providing hope to patients. Plans for the next year's program will be outlined at the upcoming EASL 2023 congress.
