bluebird bio
NEWS
Despite pricing concerns for bluebird bio’s FDA-approved sickle cell disease gene therapy, the biotech has inked a deal with an unnamed commercial payer “representing approximately 100 million covered lives” in the U.S.
These factors, along with bluebird bio’s failure to receive a priority review voucher, all hurt the company’s stock price following Lyfgenia’s approval.
Friday’s FDA approval of Vertex-CRISPR’s Casgevy and bluebird bio’s Lyfgenia has immediately revealed startling differences between these two gene therapies: price and a black-box warning.
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.
The biotech company is looking to forge a path to profitability by scaling up the commercial uptake of Zynteglo and winning the FDA’s approval for its lovo-cel gene therapy for sickle cell disease.
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
In an earnings call Wednesday, bluebird bio revealed it is unlikely to meet its first-quarter goal to submit a Biologics License Application for sickle cell disease (SCD) gene therapy lovo-cel.
bluebird bio, Inc. is expecting gross proceeds of $120 million with its newly announced public offering of 20,000,000 shares.
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IN THE PRESS
bluebird bio, Inc. announced that it has commenced an underwritten public offering of $150,000,000 of shares of its common stock.
Updated data from bluebird bio inc.’s gene therapy program in transfusion-dependent beta-thalassemia were presented at the 65th American Society of Hematology Annual Meeting & Exposition.
bluebird bio, Inc. announced new and updated efficacy, safety and health-related quality of life data from the Phase 1/2 HGB-206 Group C and Phase 3 HGB-210 studies of lovotibeglogene autotemcel gene therapy for sickle cell disease through five years of follow-up.
bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird bio” or “bluebird”) today announced the U.S. Food and Drug Administration (FDA) has approved LYFGENIA™ (pronounced as ‘lif-JEN-ee-uh’) (lovotibeglogene autotemcel), also known as lovo-cel, for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events (VOEs).
bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the third quarter ended September 30, 2023, including recent commercial and operational progress, and regulatory updates.
bluebird bio, Inc. announced that new long-term efficacy, safety and health-related quality of life follow-up data from its lentiviral vector gene therapy programs in patients with sickle cell disease who have a history of vaso-occlusive events and patients with beta-thalassemia who require regular red blood cell transfusions will be presented at the 65th American Society of Hematology Annual Meeting and Exposition.
bluebird bio, Inc. announced that it has entered into an agreement to sell a Rare Pediatric Disease Priority Review Voucher, if received, in connection with the potential approval of lovotibeglogene autotemcel for sickle cell disease.
bluebird bio, Inc. (Nasdaq: BLUE) announced today that it will host a conference call to discuss third quarter 2023 financial results and business updates on Tuesday, November 7 at 8:00 a.m. ET.
bluebird bio, Inc. announced that members of the management team will participate in fireside chats at the following upcoming investor conferences.
bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has communicated that an advisory committee meeting will not be scheduled for lovotibeglogene autotemcel (lovo-cel).