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Albireo Pharma (Nasdaq: ALBO) has completed patient enrollment in the BOLD Phase 3 trial for Bylvay, focusing on biliary atresia. This trial, the largest of its kind, involves 205 patients and aims to report topline data by the end of 2024. The FDA and EMA have indicated that a positive outcome from this single study could suffice for approval. Bylvay, previously approved for other liver conditions, is expected to change the treatment landscape for biliary atresia, a disease lacking effective therapies.
Albireo Pharma (Nasdaq: ALBO) announced two late-breaker presentations at the AASLD The Liver Meeting 2022, highlighting new data from the Phase 3 ASSERT study in Alagille syndrome (ALGS) and findings from the PEDFIC 1 trial showing restoration of bile acid secretion in PFIC patients. The ASSERT trial demonstrated statistically significant reductions in pruritus and serum bile acid levels in patients treated with Bylvay. The company also revealed six additional abstracts focusing on Bylvay's efficacy across various PFIC types and ongoing clinical trials for pediatric liver diseases.
Albireo Pharma will host a conference call and webcast on November 8, 2022, at 4:30 PM ET to discuss its financial results for the third quarter ended September 30, 2022. The call will provide a business update and review financial metrics of interest to investors.
Bylvay, Albireo’s lead product for treating pruritus in progressive familial intrahepatic cholestasis, continues to advance with ongoing Phase 3 studies in additional liver diseases.
Albireo Pharma presented new data at the NASPGHAN meeting indicating that earlier treatment with Bylvay (odevixibat) significantly improves efficacy in children with progressive familial intrahepatic cholestasis (PFIC). The data shows a direct correlation between pruritus relief and improvements in liver function, sleep quality, and overall quality of life. Specifically, 45% of patients with mild hepatic impairment showed a positive serum bile acid response. Bylvay is the first FDA-approved treatment for PFIC, and the findings suggest that initiating treatment at earlier disease stages can lead to better health outcomes.
Albireo Pharma (Nasdaq: ALBO) announced its participation in the Wainwright 3rd Annual Hepatitis B Virus Conference on October 18, 2022, where it will present and host investor meetings.
The company develops novel bile acid modulators for pediatric and adult liver diseases, with its lead product, Bylvay, FDA-approved for treating pruritus in progressive familial intrahepatic cholestasis (PFIC).
Bylvay is also undergoing trials for other liver diseases and is reimbursed in several European countries. The company has a strong pipeline, including ongoing studies for new treatments.
Albireo Pharma (Nasdaq: ALBO) announced positive results from the Phase 3 ASSERT study for its drug Bylvay, indicating significant improvement in pruritus in Alagille syndrome (ALGS) patients (p=0.002) and a notable reduction in serum bile acids (p=0.001). The treatment was well tolerated, with no patient discontinuations and a low incidence of drug-related diarrhea (11.4% vs. 5.9% placebo). Following these results, Albireo plans to file for regulatory approval in the U.S. and EU, expanding Bylvay's indication. With over $270 million in cash, the company is positioned to enhance its clinical programs.
Albireo Pharma (ALBO) announced the acceptance of seven abstracts for presentation at the AASLD The Liver Meeting 2022, including an oral presentation on long-term data demonstrating Bylvay (odevixibat) efficacy in patients with progressive familial intrahepatic cholestasis (PFIC). The event will take place from November 4-8, 2022, in Washington, D.C. Additionally, one abstract will cover A3907, a new ASBT inhibitor aimed at adult liver disease treatment. Bylvay is the first FDA-approved drug for pruritus in PFIC patients.
On September 27, 2022, Albireo Pharma (Nasdaq: ALBO) announced the grant of 13,700 inducement restricted stock units, aimed at attracting new employees. These units will vest over four years, with 25% vesting on the first anniversary and the remaining 75% in quarterly installments. This grant aligns with Nasdaq Listing Rule 5635(c)(4). Albireo specializes in developing bile acid modulators for rare liver diseases, with its lead product Bylvay recently approved for treating pruritus associated with progressive familial intrahepatic cholestasis (PFIC).
Albireo Pharma (Nasdaq: ALBO) has entered a royalty monetization agreement with Sagard Healthcare Partners, receiving $115 million upfront to support the development of Bylvay. In exchange, Sagard will earn a mid-single digit average royalty rate on Bylvay's global net revenues. This agreement strengthens Albireo's financial position, extending its cash runway until at least 2024. Sagard's investment reflects confidence in Bylvay's potential in treating progressive familial intrahepatic cholestasis (PFIC) and other rare liver diseases.
BOSTON, Sept. 20, 2022 - Albireo Pharma, Inc. (Nasdaq: ALBO) announced its participation in the Guggenheim Therapeutics Conference in Nantucket, MA, from September 27-29, 2022. CEO Ron Cooper will present on September 28 at 8:30 AM ET. A replay of the webcast will be available on the Albireo Investors page.
Albireo focuses on developing bile acid modulators for treating liver diseases. Its lead product, Bylvay, is FDA-approved for pruritus in progressive familial intrahepatic cholestasis (PFIC) and is being studied for other liver diseases. In Europe, Bylvay is reimbursed for PFIC.
