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Albireo Pharma (NASDAQ: ALBO) is showcasing new data on its investigational drug, odevixibat, at the NASPGHAN 2020 Annual Meeting. Odevixibat, developed for treating rare pediatric liver diseases like PFIC, biliary atresia, and Alagille syndrome, is a non-systemic ileal bile acid transport inhibitor. The company plans to complete regulatory filings for odevixibat in PFIC by early 2021, aiming for approval and market launch in the second half of 2021. The largest Phase 3 trial for biliary atresia, the BOLD trial, is also ongoing, underscoring Albireo’s commitment to rare liver diseases.
Albireo Pharma supports PFIC Awareness Day 2020, partnering with the PFIC Advocacy and Resource Network to address challenges faced by patients with progressive familial intrahepatic cholestasis (PFIC). This rare genetic disorder leads to severe liver disease and symptoms like intense itching and jaundice. Recognizing the need for increased research and education, Albireo emphasizes its commitment to developing odevixibat, aiming to become the first approved treatment for PFIC. The company also promotes awareness and advocacy through social media campaigns and connections with global families.
Albireo Pharma (Nasdaq: ALBO) announced the grant of inducement stock options totaling 23,000 shares, exercisable at $32.90 per share. This grant aligns with Nasdaq Listing Rule 5635(c)(4) as an inducement tied to new employee hires. The options feature a 10-year term with vesting occurring over four years, 25% vesting after one year and the rest in quarterly installments. Albireo Pharma is focused on developing novel bile acid modulators for orphan pediatric liver diseases, with lead candidate odevixibat in Phase 3 trials for conditions like PFIC and biliary atresia.
Albireo Pharma, Inc. (Nasdaq: ALBO) has announced the pricing of an underwritten public offering of 4,000,000 shares of common stock at $40.00 each, aiming to raise approximately $160 million before fees. The offering is expected to close around September 14, 2020, pending customary conditions. The underwriters also have a 30-day option to purchase an additional 600,000 shares. Cowen and William Blair lead as joint book-running managers for the offering. This offering is in alignment with Albireo's focus on developing bile acid modulators for orphan pediatric liver diseases.
Albireo Pharma announced positive results from the PEDFIC 1 Phase 3 trial for odevixibat, targeting progressive familial intrahepatic cholestasis (PFIC). The study achieved significant reductions in serum bile acids and improved pruritus in patients, outperforming placebo. Notably, 53.5% of patients on odevixibat reported positive pruritus assessments compared to 28.7% on placebo. Odevixibat was well tolerated, with a low incidence of diarrhea. The company anticipates regulatory submissions for approval in early 2021 and ongoing efforts in other pediatric liver diseases.
Albireo Pharma (ALBO) announced that it will reveal topline results from the PEDFIC 1 Phase 3 trial for its lead candidate, odevixibat, on September 8, 2020. This trial evaluates the efficacy and safety of odevixibat for treating progressive familial intrahepatic cholestasis (PFIC). Following the announcement, company management will host a conference call and live audio webcast to discuss the results at 8:30 a.m. EDT. Odevixibat is also in development for biliary atresia and a Phase 3 trial for Alagille syndrome is being planned.
Albireo Pharma (NASDAQ: ALBO) announced topline results from its Phase 2 trial of elobixibat for NAFLD/NASH, achieving the primary endpoint of a 20.5 mg/dL reduction in LDL-C compared to placebo (p<0.022). However, key NASH measures showed unremarkable results, leading the company to discontinue further development of elobixibat for NASH. Despite this setback, Albireo remains focused on advancing odevixibat for rare pediatric liver diseases, with key milestones expected in the coming months, including Phase 3 trials and regulatory approvals.
Albireo Pharma (Nasdaq: ALBO), a clinical-stage biopharmaceutical company, announced that CEO Ron Cooper will participate in a fireside chat at the William Blair Biotech Focus Conference 2020 on August 6 at 2 p.m. EDT. The presentation will be available live via webcast on Albireo’s Media & Investors page, with a recommendation to register 15 minutes before the event. An archived version will be accessible for two weeks post-event. Albireo focuses on innovative bile acid modulators for treating orphan pediatric liver diseases, with its lead candidate, odevixibat, advancing in Phase 3 development.
Albireo Pharma (Nasdaq: ALBO) announced a conference call on August 6, 2020, at 10:00 a.m. ET to discuss its Q2 2020 financial results and business updates. The company is developing bile acid modulators for pediatric liver diseases, with its lead candidate odevixibat in Phase 3 trials for progressive familial intrahepatic cholestasis (PFIC) and biliary atresia. Another candidate, elobixibat, is in Phase 2 for NAFLD and NASH, and is already approved in Japan for chronic constipation. Albireo operates from Boston and is recognized as one of Massachusetts' Best Places to Work.
Albireo Pharma, Inc. (Nasdaq: ALBO) has launched an Expanded Access Program (EAP) for its investigational drug, odevixibat, aimed at patients with progressive familial intrahepatic cholestasis (PFIC) across the U.S., Canada, Australia, and Europe. This initiative comes as a response to the urgent need for effective treatments for PFIC, an ultra-rare pediatric liver disease. The program aims to provide access to odevixibat until it becomes commercially available, further supported by ongoing clinical trials. Patients with no other therapeutic options are eligible for this program.
