bluebird bio
NEWS
With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science.
To help support the launch of Lyfgenia, bluebird bio on Monday entered into a five-year term loan deal with Hercules Capital that will extend the biotech’s cash runway through the first quarter of 2026.
Vertex and CRISPR Therapeutics are setting up treatment centers for patients with beta thalassemia and sickle cell disease to compete with bluebird’s established infrastructure.
Under the deal disclosed Thursday in an SEC filing, bluebird bio doubled the number of covered U.S. patients for its sickle cell gene therapy to a cumulative total of around 200 million people.
Cash-strapped bluebird bio is aiming to raise a quarter of a billion dollars through two funding vehicles—a public offering and a deal with finance firm Alterna—to support its general and commercialization operations.
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.
JOBS
IN THE PRESS
bluebird bio, Inc. announced the pricing of its underwritten public offering of 83,333,333 shares of its common stock at a public offering price of $1.50 per share, before deducting underwriting discounts and commissions.
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.