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Albireo Pharma, Inc. (Nasdaq: ALBO) announced its participation in upcoming investor conferences. Ron Cooper, CEO, and Simon Harford, CFO, will present at the Jefferies London Healthcare Conference on November 17 at 11:20 a.m. GMT. Additionally, a pre-recorded fireside chat will be available at the Piper Sandler 33rd Annual Virtual Healthcare Conference starting November 22 at 10:00 a.m. ET. Webcasts will be accessible via Albireo's website.
Albireo Pharma (ALBO) announced significant developments, including the U.S. and European approval of Bylvay (odevixibat) for treating pruritus in progressive familial intrahepatic cholestasis (PFIC), generating $1.1 million in partial Q3 revenue.
Phase 3 studies are enrolling, with topline data expected in 2022 and 2024. The company secured $120 million in non-dilutive capital via a Priority Review Voucher sale and a Japan licensing agreement. Net income for Q3 2021 reached $57.1 million, driven by the PRV sale, with positive guidance projecting 2021 revenue from Bylvay at $3-4 million.
Albireo Pharma (Nasdaq: ALBO) will host a conference call on November 4, 2021 at 10:00 a.m. ET to discuss its Q3 2021 financial results. The call will be accessible via phone or through a live audio webcast on the company's website. Albireo is focused on developing novel bile acid modulators to treat rare liver diseases. Its lead product, Bylvay (odevixibat), has received FDA approval for treating pruritus associated with progressive familial intrahepatic cholestasis (PFIC) and is also being evaluated for other rare liver diseases.
Albireo Pharma, Inc. (Nasdaq: ALBO) announced the acceptance of seven abstracts for presentation at the AASLD Liver Meeting 2021. The data includes findings from the Phase 3 PEDFIC studies on the efficacy of Bylvay (odevixibat) in pediatric cholestatic liver disease and insights into the novel NTCP inhibitor, A2342. A post-conference call is scheduled for November 16, 2021, featuring key company executives discussing the presented data. Bylvay has gained marketing authorization in the U.S. and Europe for treating pruritus associated with progressive familial intrahepatic cholestasis.
Albireo Pharma has secured a significant licensing agreement with Jadeite Medicines for the commercialization of Bylvay (odevixibat) in Japan, targeting conditions like PFIC and Alagille syndrome. The deal entails an upfront payment of $15 million, with potential milestone payments up to $120 million and double-digit royalties. Bylvay is already approved in the U.S., EU, and UK, marking a notable step in expanding its market presence, particularly in Japan where demand is high due to the lack of approved treatments.
Albireo Pharma (Nasdaq: ALBO) recognized PFIC Awareness Day 2021, joining the PFIC Advocacy and Resource Network to support families affected by progressive familial intrahepatic cholestasis (PFIC). PFIC is a rare liver disease that can lead to severe itching and liver failure. Albireo has launched Bylvay™, the first drug approved in the U.S. for treating PFIC pruritus. The company is actively raising awareness and collaborating with advocacy groups to enhance research and resources for the PFIC community.
Albireo Pharma announced that its drug, Bylvay (odevixibat), is now available in Germany as the first non-surgical treatment for all forms of progressive familial intrahepatic cholestasis (PFIC). Approved in the U.S., EU, and UK, Bylvay is administered once daily and does not require refrigeration. The company anticipates strong interest from healthcare providers, supported by a customized patient program, Albireo Assist. Additionally, a value dossier has been submitted for reimbursement assessment. Albireo aims to expand access to Bylvay across Europe.
Albireo Pharma (Nasdaq: ALBO) announced the grant of inducement stock options for 15,000 shares and restricted stock units for 3,500 shares, both at an exercise price of $29.50, the closing price on September 7, 2021. These grants incentivize new hires and vest over four years, with 25% vesting after the first year. Albireo focuses on developing novel bile acid modulators for rare pediatric liver diseases, with its product Bylvay already approved by the U.S. FDA for specific conditions. The company also has ongoing Phase 3 trials and a Phase 1 clinical trial for additional treatments.
Albireo Pharma announces major progress with the approval of Bylvay (odevixibat) by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for treating progressive familial intrahepatic cholestasis (PFIC). This marks Bylvay as the first drug approved for all forms of PFIC, following its earlier authorization by the European Commission in July 2021. The approval is based on significant results from the largest Phase 3 trials, which demonstrated safety and efficacy. Albireo is now focused on commercializing Bylvay in Europe and ensuring broad access for patients.
Albireo Pharma (Nasdaq: ALBO) announced the sale of its Priority Review Voucher (PRV) for $105 million, a move aimed at strengthening its financial position. This PRV was granted following the FDA approval of Bylvay (odevixibat), the first treatment for pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The funds will support ongoing clinical trials and the advancement of new product candidates, while Albireo's cash and short-term investments stand at $186.3 million as of June 30, 2021.
