bluebird bio
NEWS
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.
The FDA’s top five approvals in 2022 represent an eclectic mix of cancer, cardiovascular and rare disease drugs.
The FDA lifted its partial clinical hold on bluebird’s experimental sickle cell disease gene therapy for patients younger than 18.
While worthy advances have recently been made in sickle cell disease, companies such as Graphite Bio, bluebird bio, Vertex Pharmaceuticals and Editas Medicine have loftier ambitions.
JOBS
IN THE PRESS
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).
bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the second quarter ended June 30, 2023, including recent commercial and operational progress, and regulatory updates.
bluebird bio, Inc. (Nasdaq: BLUE) today announced it will hold a conference call to discuss second quarter 2023 financial results and provide a commercial update on Tuesday, August 8 at 8:00 a.m. ET. In addition to providing an overview of the business, the conference call will highlight the Company’s ongoing commercial launches of SKYSONA ® and ZYNTEGLO ® and the market opportunity for lovo-cel.
bluebird bio, Inc . (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review.
bluebird bio, Inc. reported financial results and business highlights for the first quarter ended March 31, 2023, including recent commercial and operational progress, and regulatory updates.
bluebird bio, Inc. announced that the Company’s first quarter financial results, including commercial, regulatory and operational updates, will be released pre-market on Tuesday, May 9.
bluebird bio, Inc . (Nasdaq: BLUE) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events.
bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlight.
bluebird bio, Inc. announced the pricing of its underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $6.00 per share, before deducting underwriting discounts and commissions.
bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird”) today announced that it has commenced an underwritten public offering of 20,000,000 shares of its common stock.