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Albireo Pharma (Nasdaq: ALBO) announced that the Italian Medicines Agency (AIFA) has granted reimbursed access to Bylvay (odevixibat) for all types of progressive familial intrahepatic cholestasis (PFIC) patients in Italy. This decision marks Bylvay as the first approved medication for PFIC, which severely impacts liver function in children. AIFA also awarded Bylvay with 'Full Therapeutic Innovation' status, emphasizing its clinical benefits and scientific evidence. Albireo's progress with Bylvay, including ongoing clinical studies, positions it favorably within the growing market for rare liver disease treatments.
BOSTON, Sept. 01, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO) announced its participation in key investor conferences. The Wells Fargo Securities Healthcare Conference is scheduled for September 8, 2022, featuring CFO Simon Harford and SVP Colleen Alabiso. On September 12, the Morgan Stanley 20th Annual Global Healthcare Conference will host a fireside chat with CEO Ron Cooper. That day also includes the H.C. Wainwright Global Investment Conference, with participation by CCO Pamela Stephenson. Ron Cooper will present at the Baird 2022 Global Healthcare Conference on September 13, 2022.
Albireo Pharma (Nasdaq: ALBO) has announced the grant of inducement restricted stock units totaling 17,300 shares as part of new employee contracts. These units are tied to the employee's acceptance of employment and align with Nasdaq's Listing Rule 5635(c)(4). The stock units vest over four years, starting with 25% on the one-year anniversary, followed by 75% in quarterly installments. Albireo focuses on developing bile acid modulators for rare liver diseases and has FDA-approved treatments, including Bylvay, for conditions like progressive familial intrahepatic cholestasis (PFIC).
Albireo Pharma reported Q2 2022 net product revenue of $5.9 million from Bylvay, with year-to-date revenue reaching $10.5 million. The number of Bylvay patients grew by 18% to 245, with expanded reimbursement confirmed in multiple countries, including Italy and Belgium. Upcoming milestones include topline data from the Phase 3 ASSERT study in Alagille syndrome expected this fall. However, net loss for the quarter was $39.9 million, or $(2.04) per share, with cash reserves decreasing to $181 million. The company anticipates sufficient cash through 2024.
Albireo Pharma (Nasdaq: ALBO) announced the appointment of Habib Dable and Susan Alesina to its Board of Directors, enhancing its leadership with extensive experience in pharmaceuticals and biotechnology. Dable, former President and CEO of Acceleron Pharma, brings over 28 years of global operations expertise, while Alesina, VP at Boston Children's Hospital, has 25 years of experience in business development. These appointments aim to bolster Albireo's strategic planning and support the growth of their lead product, Bylvay, designed to treat rare liver diseases.
Albireo Pharma, Inc. (Nasdaq: ALBO) announced its participation in the 2022 Wedbush PacGrow Healthcare Conference on August 9-10, 2022. Ron Cooper, the CEO, will present on August 9, with an on-demand webcast available afterward on the company's investor page. Albireo focuses on developing novel bile acid modulators for rare liver diseases, with its lead product, Bylvay, already FDA-approved for treating pruritus in progressive familial intrahepatic cholestasis (PFIC). The company is also advancing clinical trials for other liver diseases.
Albireo Pharma (Nasdaq: ALBO) will host a conference call and audio webcast on August 15, 2022, at 4:30 p.m. ET to discuss its financial results for Q2 2022. The call aims to provide a business update and review of the company's developments in rare liver diseases, including its lead product, Bylvay, approved for treating progressive familial intrahepatic cholestasis (PFIC). Bylvay is also undergoing global Phase 3 trials for other rare pediatric liver diseases, showcasing the company’s commitment to innovative treatments.
Albireo Pharma (Nasdaq: ALBO) announced the grant of 16,200 inducement restricted stock units to a new employee, following Nasdaq Listing Rule 5635(c)(4). These stock units will vest over four years, with 25% vesting after one year and the remaining 75% vested quarterly. The plan aims to incentivize employee retention. Albireo focuses on developing novel bile acid modulators for rare liver diseases, with its lead product, Bylvay, approved for treating pruritus in progressive familial intrahepatic cholestasis.
Albireo Pharma (Nasdaq: ALBO) announced the successful results of the PEDFIC 1 trial for Bylvay (odevixibat), the first pediatric Phase 3 trial in cholestatic liver disease. The study showed significant improvements in pruritus severity scores and reductions in serum bile acid levels. Conducted from May 2018 to July 2020, it involved 62 patients aged 6 months to 15.9 years. Bylvay was well tolerated, showing a favorable safety profile. The treatment has received approvals in the U.S. and Europe for treating all types of progressive familial intrahepatic cholestasis (PFIC).
Albireo Pharma (Nasdaq: ALBO) will participate in the William Blair Biotech Focus Conference on July 12-13, 2022. CEO Ron Cooper will engage in a fireside chat, while CFO Simon Harford will also hold meetings during the event. The fireside chat will be broadcasted on the company’s website and will be available for 30 days post-event. Albireo focuses on developing novel bile acid modulators to treat rare pediatric and adult liver diseases, with its leading product, Bylvay, recently approved by the U.S. FDA for treating pruritus in progressive familial intrahepatic cholestasis (PFIC).
