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BOSTON, Jan. 07, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma (Nasdaq: ALBO) has announced a virtual Commercial Day for investors scheduled on February 11, from 11:30 AM to 1:00 PM EST. Presentations will cover the company's long-term strategy, market opportunities in rare liver diseases, and commercialization plans for odevixibat, aimed at treating progressive familial intrahepatic cholestasis (PFIC). The event will be led by CEO Ron Cooper and other leaders. Interested parties can join the call using the provided dial-in details or through the company's investor webpage.
Albireo Pharma, Inc. (Nasdaq: ALBO) announced the grant of inducement stock options for 18,500 shares at an exercise price of $36.98 per share. These options were granted to new employees as part of their employment acceptance, complying with Nasdaq Listing Rule 5635(c)(4). Each option has a 10-year term and vests over four years. Albireo focuses on developing novel bile acid modulators for rare liver diseases, with its lead product odevixibat entering Phase 3 trials for pediatric cholestatic liver diseases, including PFIC and biliary atresia.
BOSTON, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma (Nasdaq: ALBO), a clinical-stage company focused on novel bile acid modulators, announced CEO Ron Cooper's participation in the H.C. Wainwright Virtual BioConnect 2021 Conference from January 11-14, 2021. Additionally, he will present at the LifeSci Advisors 10th Annual Corporate Access Event on January 8, 2021, at 12:00 pm EST. Both events will be available for replay on Albireo's website for two weeks after. The company is developing treatments for rare liver diseases, with key products in pivotal trials.
Albireo Pharma has initiated its global Phase 3 trial, ASSERT, to evaluate odevixibat for safety and efficacy in treating Alagille syndrome. This study represents Albireo’s third Phase 3 trial for rare cholestatic liver diseases. Odevixibat is a once-daily, non-systemic ileal bile acid transport inhibitor. Both the FDA and EMA have agreed on the study design, and enrollment targets approximately 45 patients aged 0-17 across multiple regions. Additionally, odevixibat has received various designations and submissions for PFIC treatment are currently under review.
Albireo Pharma (Nasdaq: ALBO) announced the grant of inducement stock options for 18,500 shares at $39.77 each, equal to the closing stock price on December 9, 2020. These options are part of the company’s strategy to attract employees and will vest over four years. Albireo focuses on developing novel bile acid modulators for rare liver diseases, with its lead candidate, odevixibat, in Phase 3 trials for conditions like progressive familial intrahepatic cholestasis and biliary atresia.
Albireo Pharma has submitted an NDA to the FDA and an MAA to the EMA for odevixibat, targeting progressive familial intrahepatic cholestasis (PFIC). The EMA has validated this application for accelerated assessment. Odevixibat aims to be the first approved treatment for PFIC in the U.S. and Europe. The drug received Fast Track and Orphan Drug designations, with previous studies indicating improvements in patients' quality of life. The company is also preparing for a Phase 3 trial for Alagille syndrome and expects potential approvals by mid-2021.
Albireo Pharma (Nasdaq: ALBO) announced positive interim results from the Phase 3 PEDFIC 1 and PEDFIC 2 studies for odevixibat, demonstrating significant reductions in serum bile acids and pruritus among PFIC patients. The studies met primary endpoints in both the U.S. and EU, showcasing the treatment’s potential to transform care in this patient group. Notable outcomes included sustained improvements in growth and liver parameters, with odevixibat generally well tolerated. Regulatory filings in the U.S. and EU are anticipated as next steps.
Albireo Pharma (Nasdaq: ALBO), a clinical-stage biopharmaceutical company specializing in rare liver diseases, announced that CEO Ron Cooper will present at the Jefferies London Healthcare Conference on November 19, 2020, at 12 p.m. EST. The company is also participating in the Piper Sandler 32nd Annual Healthcare Conference from December 1-3. A live audio webcast will be available on Albireo's Media & Investors page and archived for two weeks. Albireo focuses on novel bile acid modulators, with its lead product, odevixibat, in Phase 3 trials for pediatric cholestatic liver diseases.
Albireo Pharma reported positive Phase 3 results for odevixibat in PFIC, achieving statistical significance on primary endpoints.
The company anticipates regulatory filings by early 2021 and potential product launch in the second half of the year.
Albireo raised $160 million in its public offering, boosting cash reserves to $278.7 million, sufficient for commercial launches.
The company's Q3 revenue rose to $2.1 million, but net loss increased to $30.7 million.
Albireo Pharma, Inc. (Nasdaq: ALBO) announced that the American Association for the Study of Liver Diseases accepted late-breaking abstracts for the Phase 3 PEDFIC 1 and PEDFIC 2 trials. These trials evaluate odevixibat's efficacy in children with progressive familial intrahepatic cholestasis (PFIC). PEDFIC 1 achieved high statistical significance in its endpoints, demonstrating odevixibat's effectiveness in reducing bile acids and improving patient growth. The results will be presented at AASLD’s The Liver Meeting 2020, enhancing Albireo’s profile in rare liver disease treatment.
