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Albireo Pharma (Nasdaq: ALBO) has announced significant progress in its clinical trials, including the first patients dosed in the Phase 1 study of A3907, a new oral treatment for adult cholestatic liver diseases. The company also initiated the ASSERT global Phase 3 study for odevixibat, aimed at treating Alagille syndrome. The FDA is reviewing odevixibat for PFIC, with a PDUFA goal date set for July 20, 2021. Both developments highlight Albireo's commitment to expanding its pipeline and meeting regulatory expectations, with topline data anticipated for A3907 in late 2021 and odevixibat in 2022.
Albireo Pharma (Nasdaq: ALBO) supports Rare Disease Day 2021, aiming to raise awareness of rare cholestatic liver diseases. The initiative focuses on connectivity within the patient community, launching an Instagram page for Progressive Familial Intrahepatic Cholestasis (PFIC) to share experiences. CEO Ron Cooper emphasized the importance of engaging with patients in advancing research for liver diseases like PFIC and Alagille syndrome. Albireo is in Phase 3 trials for its product candidate, odevixibat, which targets these rare conditions.
Albireo Pharma (ALBO) announced significant updates, including the acceptance of the NDA and MAA for odevixibat, anticipating a launch in H2 2021. The company initiated two pivotal Phase 3 trials for Alagille syndrome and biliary atresia, while expanding its pipeline with new compounds for liver diseases. In Q4 2020, revenues decreased to $2.7 million from $6.4 million YoY, with a net loss of $24.8 million. Despite increased R&D and G&A expenses, Albireo has $251.3 million in cash, ensuring adequate funding for its commercialization plans.
BOSTON, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma (Nasdaq: ALBO) announced its participation in the Cowen 41st Annual Health Care Conference from March 1-4, 2021. CEO Ron Cooper will join the New Drug Launches Panel on March 3 at 10:20am ET. The management team will also meet with investors on March 2.
Additionally, Albireo will participate in the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021, with CFO Simon Harford and CCO Pamela Stephenson holding a fireside chat on March 9 at 7am ET. Meetings with investors will also occur on March 9.
Albireo Pharma (Nasdaq: ALBO) will hold a conference call on February 25, 2021, at 10:00 a.m. ET, to share a business update and review financial results for Q4 and the year ended December 31, 2020. The company, focused on developing novel bile acid modulators for rare pediatric liver diseases, will discuss its lead candidate, odevixibat, undergoing Phase 3 pivotal trials.
For participation, call 877-407-0792 (domestic) or 201-689-8263 (international), using access code 13715566. A webcast will also be available on their website.
Albireo Pharma (Nasdaq: ALBO) announced the grant of inducement stock options for a total of 18,500 shares, exercisable at $38.39 per share, the closing price on February 16, 2021. These options, crucial for new employee hires, have a 10-year term and vest over four years. The grant complies with Nasdaq Listing Rule 5635(c)(4). Albireo focuses on developing bile acid modulators for rare liver diseases, with its lead candidate, odevixibat, in Phase 3 trials for pediatric cholestatic liver diseases. The company was recognized as one of the Best Places to Work in Massachusetts for 2020.
Albireo Pharma (ALBO) is advancing its plans for the U.S. and EU launch of odevixibat, aimed at treating progressive familial intrahepatic cholestasis (PFIC) and expanding into additional rare liver diseases. The company received priority and accelerated reviews from the FDA and EMA for odevixibat. The global market potential for pediatric cholestatic liver diseases is larger than anticipated, with approximately 100,000 patients in the top 25 global markets. Albireo is well-positioned financially to support the commercialization and development of odevixibat, with a cash runway into 2023.
Albireo Pharma announces FDA acceptance of its New Drug Application (NDA) for odevixibat, aimed at treating pruritus in Progressive Familial Intrahepatic Cholestasis (PFIC). The FDA has granted Priority Review, with a PDUFA date set for July 20, 2021. Odevixibat could become the first approved treatment for PFIC, a rare liver disease affecting children. The NDA submission is backed by positive results from Phase 3 studies, demonstrating efficacy in reducing pruritus and serum bile acids. The company anticipates a potential launch in the second half of 2021.
Albireo Pharma (Nasdaq: ALBO) supports the Alagille syndrome community during the second annual International Alagille Syndrome Awareness Day on January 24, 2021. The company emphasizes its commitment to advancing research for rare cholestatic liver diseases and enhancing treatment options for affected families. CEO Ron Cooper highlights the importance of community feedback in designing the ongoing Phase 3 study, ASSERT, which seeks to enroll eligible patients. Currently, no approved drug treatments exist for Alagille syndrome, impacting approximately 95% of patients.
Albireo Pharma, Inc. (Nasdaq: ALBO) announced the grant of inducement stock options for 18,500 shares at $37.22 per share, reflecting the January 11, 2021 closing price. These options, linked to new employee hires, vest over four years with a 10-year term. Albireo specializes in developing bile acid modulators for rare liver diseases, with its lead candidate, odevixibat, advancing through Phase 3 trials for conditions such as PFIC. The company, spun out from AstraZeneca, is headquartered in Boston, MA.
