Welcome to our dedicated page for ALBO news (Ticker: ALBO), a resource for investors and traders seeking the latest updates and insights on ALBO stock.
Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect ALBO's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.
Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of ALBO's position in the market.
Albireo Pharma (Nasdaq: ALBO) announced significant data presentations at the EASL International Liver Congress 2021, including results from the Phase 3 PEDFIC studies for Bylvay (odevixibat) in pediatric cholestatic liver diseases. Highlights include improved clinical outcomes in cholestasis in children and the potential for Bylvay to become the first approved treatment for PFIC patients in the U.S. and Europe. The FDA has a PDUFA goal date of July 20, 2021, while the EMA issued a positive opinion for Bylvay's approval. The company is also advancing A3907 for adult cholestatic liver disease.
Albireo Pharma presented promising data from its Phase 3 PEDFIC studies on Bylvay (odevixibat), showing significant long-term benefits for children with progressive familial intrahepatic cholestasis (PFIC). Key outcomes highlighted include improved growth, reduced total bilirubin levels, and enhanced sleep patterns over up to 48 weeks of treatment. No serious drug-related adverse events were reported, indicating strong safety and tolerability. The FDA has set a PDUFA goal date of July 20, 2021, for Bylvay’s approval in the U.S., marking it as a potential first treatment for PFIC.
Albireo Pharma (Nasdaq: ALBO) will feature Ron Cooper, CEO, in presentations at the 2021 Jefferies Virtual Healthcare Conference on June 2 at 9:30 a.m. EDT and the William Blair Annual Growth Stock Conference on June 3 at 12:40 p.m. EDT. Investor meetings are scheduled from June 1-3. Live webcasts can be found on Albireo's Media & Investors page, with replays available for two weeks post-event. Albireo focuses on novel bile acid modulators for rare liver diseases, with its lead product Bylvay under FDA Priority Review for PFIC, aiming for a decision by July 20, 2021.
Albireo Pharma announced a positive opinion from the EMA's CHMP recommending Bylvay (odevixibat) for treating PFIC. The PEDFIC Phase 3 studies demonstrated significant efficacy with primary endpoints met: bile acid reduction (P=0.003) and pruritus relief (P=0.004). Bylvay could be the first non-surgical treatment for PFIC, a severe liver disease affecting children. Anticipating EU marketing authorization, Albireo has a commercial organization ready for launch. Additionally, the FDA has a Priority Review for Bylvay in the U.S., with a decision expected by July 20, 2021.
Albireo Pharma has shared new Phase 3 data on its drug Bylvay (odevixibat) at the WCPGHAN Meeting, highlighting its long-term safety and efficacy for treating progressive familial intrahepatic cholestasis (PFIC). The data showed significant improvements in total bilirubin levels, growth, and sleep patterns among patients. Bylvay, a non-systemic bile acid transport inhibitor, is positioned to be the first non-surgical treatment for PFIC, with the FDA's PDUFA date set for July 20, 2021. The drug has received Priority Review and Orphan Drug Designation, suggesting strong regulatory support.
Albireo Pharma (Nasdaq: ALBO) has granted inducement stock options for 18,500 shares at $30.37 each as part of employee recruitment. These options will vest over four years, with 25% vesting after one year and the remainder in quarterly installments. The grant complies with Nasdaq Listing Rule 5635(c)(4). Albireo is focused on developing bile acid modulators for rare liver diseases, with its lead product, Bylvay, under FDA Priority Review, targeting a PDUFA goal date of July 20, 2021. The company was recognized as one of the Best Places to Work in Massachusetts in 2020.
Albireo Pharma (ALBO) reported a net loss of $43.7 million, or $(2.29) per share, for Q1 2021, with revenues of $2.0 million, up from $1.5 million in Q1 2020. The company is on track for the anticipated launch of Bylvay (odevixibat) in H2 2021, with a PDUFA goal date of July 20, 2021, for U.S. FDA approval. Global commercial agreements for Bylvay have been completed in key markets, and Phase 3 studies are ongoing. CEO Ron Cooper emphasized the need for approved therapies for pediatric cholestatic conditions. Cash resources stand at $217.1 million, allowing continued development efforts.
Albireo Pharma (Nasdaq: ALBO) has announced a conference call and webcast scheduled for May 6, 2021, at 10:00 a.m. ET, to discuss the company's first-quarter financial results. The call will provide a business update, focusing on its lead product candidate, odevixibat, currently in Phase 3 trials for rare pediatric liver diseases, including PFIC and Alagille syndrome. The company aims for FDA Priority Review with a PDUFA goal date set for July 20, 2021. Albireo is also advancing a Phase 1 trial for A3907 targeting adult cholestatic liver disease.
On April 13, 2021, Albireo Pharma (Nasdaq: ALBO) announced the appointment of Joan Connolly as Chief Technology Officer. Connolly, with over 25 years of experience, will manage drug development and supply chain functions. This appointment comes as Albireo prepares for a potential global launch of its lead product, odevixibat, aimed at treating rare pediatric cholestatic liver diseases, alongside advancing clinical programs for various liver diseases. Connolly will receive stock options and restricted stock units as part of her employment terms.
Albireo Pharma, Inc. (Nasdaq: ALBO), a company focused on developing novel bile acid modulators for rare liver diseases, will participate in the Needham 20th Annual Healthcare Conference from April 12-15. Executives Ron Cooper and Simon Harford will have a fireside chat on April 13 at 9:30 a.m. ET, available on-demand via the Albireo Media & Investors page. The company is advancing its lead product, odevixibat, through Phase 3 trials for pediatric liver diseases, and is also developing A3907 for adult cholestatic liver diseases.
