Welcome to our dedicated page for Albireo Pharma news (Ticker: ALBO), a resource for investors and traders seeking the latest updates and insights on Albireo Pharma stock.
Albireo Pharma Inc (ALBO) is a biopharmaceutical company developing treatments for rare cholestatic liver diseases, with a primary focus on pediatric conditions. The company's news coverage centers on regulatory milestones, clinical trial results, and drug approval progress for its bile acid modulator candidates targeting conditions like progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome, and biliary atresia.
News surrounding Albireo typically focuses on several key areas specific to orphan drug development. Regulatory submissions and FDA decision dates drive significant coverage, as these companies depend on approval timelines for rare disease treatments. Clinical trial enrollment updates, interim data releases, and pivotal study results provide insight into the company's progress toward commercialization. Additionally, reimbursement approvals in various countries signal market access progress for rare disease therapies.
For investors and patients following Albireo, news about Bylvay (odevixibat) regulatory activities across different jurisdictions reveals the company's commercial expansion strategy. Health authority decisions, guideline updates, and orphan drug designation announcements impact the development timeline and market potential. Conference presentations at medical meetings like the American Association for the Study of Liver Diseases (AASLD) often precede formal data releases.
This news feed provides real-time updates on Albireo's regulatory progress, clinical development milestones, and corporate developments. Tracking these announcements helps stakeholders understand the company's advancement through the complex rare disease drug development pathway.
Albireo Pharma, Inc. (Nasdaq: ALBO), focused on rare pediatric liver diseases, has announced presentations by CEO Ron Cooper and CFO Simon Harford at upcoming investor conferences. Key events include the 2021 Virtual Wells Fargo Healthcare Conference on September 9, H.C. Wainwright 23rd Annual Global Investment Conference on September 13, and Baird 2021 Global Healthcare Conference on September 14. Webcasts will be accessible through Albireo’s website, with archived versions available for 30 days post-event.
Albireo is developing bile acid modulators and has FDA-approved Bylvay for PFIC treatment.
Albireo Pharma announced the approval of Bylvay (odevixibat) as the first once-daily treatment for patients with Progressive Familial Intrahepatic Cholestasis (PFIC) in both the U.S. and Europe.
The company has received initial prescriptions in the U.S. and expects a German price listing by September. Financial results for Q2 2021 showed revenues of $2.4 million, up from $1.9 million a year prior, while net loss increased to $36.4 million, or $(1.90) per share. Operating cash burn for 2021 is projected between $130-$135 million, with cash reserves of $186.3 million.
Albireo Pharma, a company focused on rare liver diseases, will have its leadership team present at the 2021 Wedbush PacGrow Virtual Healthcare Conference on August 10 at 3:30 p.m. ET. CEO Ron Cooper and CFO Simon Harford will share insights on its innovative bile acid modulators, including Bylvay, which is approved for treating progressive familial intrahepatic cholestasis (PFIC). The presentation can be accessed via Albireo’s website. This follows the company's ongoing Phase 3 trials for Alagille syndrome and biliary atresia, and its commitment to addressing cholestatic liver diseases.
Albireo Pharma (Nasdaq: ALBO) announces a conference call on August 5, 2021, at 10:00 a.m. ET to discuss its business update and Q2 financial results for the period ending June 30, 2021. The call can be accessed via phone or live audio webcast, with registration recommended 15 minutes prior. Albireo specializes in developing novel bile acid modulators for rare liver diseases, notably with its FDA-approved product Bylvay for treating pruritus in progressive familial intrahepatic cholestasis (PFIC). The company is also advancing clinical trials for other cholestatic liver diseases.
Albireo Pharma (Nasdaq: ALBO) has received FDA approval for Bylvay (odevixibat), the first drug for treating pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). Bylvay offers a non-surgical option to address severe itching and improve quality of life for PFIC patients, predominantly affecting children. Immediate commercial launch is set, with a focus on access, reimbursement, and support programs. The FDA also issued a Rare Pediatric Disease Priority Review Voucher to Albireo. The company is studying Bylvay's application in other pediatric liver diseases, with clinical trials ongoing.
Albireo Pharma (Nasdaq: ALBO) has announced the FDA approval of Bylvay (odevixibat), the first treatment for pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). Bylvay is a non-systemic ileal bile acid transport inhibitor, easy to administer and does not require refrigeration. The drug's commercial launch is immediate, supported by data from extensive Phase 3 trials (PEDFIC 1 and 2). The FDA also issued a Rare Pediatric Disease Priority Review Voucher to Albireo, which it plans to monetize. The company reported cash reserves of $186.3 million as of June 30, 2021, to support its operations.
Albireo Pharma (NASDAQ: ALBO) announced the European Commission's approval of Bylvay (odevixibat), the first drug for treating all forms of progressive familial intrahepatic cholestasis (PFIC). This milestone follows over 20 years of research, marking a shift from surgical options to a non-invasive treatment for PFIC patients. Bylvay's efficacy was demonstrated in the largest Phase 3 trials to date (PEDFIC 1 and 2), showing significant improvements in pruritus and bile acid levels. Commercial launch is set for September 2021, and U.S. FDA review is expected to conclude on July 20, 2021.
Albireo Pharma (Nasdaq: ALBO) announced that CEO Ron Cooper will present at the William Blair Biotech Focus Conference on July 15, 2021, at 11:00 a.m. EDT. The presentation will be streamed live on Albireo’s website, with an archived version available for 30 days post-event. Albireo focuses on novel bile acid modulators for rare liver diseases. Its lead candidate, Bylvay, is under Phase 3 trials for pediatric cholestatic liver diseases. The FDA has granted Priority Review for Bylvay, with a PDUFA date set for July 20, 2021.
Albireo Pharma, a clinical-stage biopharmaceutical company focused on rare liver diseases, announced that CEO Ron Cooper will present at Piper Sandler’s Virtual EASL Takeaway Day on June 28, 2021, at 10:00 a.m. EDT. The event will be available for replay on Albireo's investor relations website for two weeks post-event. Albireo’s lead candidate, Bylvay, targets pediatric cholestatic liver diseases, with recent FDA Priority Review and a PDUFA goal date set for July 20, 2021. Bylvay has received a positive opinion from the EMA and is the only IBATi with accelerated assessment.
Albireo Pharma (ALBO) announces new data on Bylvay (odevixibat) presented at EASL International Liver Congress™ 2021, showing significant improvements in patients with progressive familial intrahepatic cholestasis (PFIC). A pooled analysis of 77 patients highlighted rapid reductions in serum bile acids and pruritus, along with growth and sleep enhancements after 48 weeks of treatment. Furthermore, the investigational A3907, an ASBT inhibitor, is progressing in Phase 1 studies, targeting adult cholestatic liver diseases. Approval timelines for Bylvay from FDA and EMA remain promising, with potential launch anticipated in H2 2021.
