bluebird bio, Inc. - BLUE STOCK NEWS

bluebird bio announced the submission of its Biologics License Application (BLA) to the FDA for lovotibeglogene autotemcel (lovo-cel) gene therapy aimed at treating sickle cell disease (SCD) in patients aged 12 and older. This submission is based on extensive clinical data, including results from 36 patients with a median follow-up of 32 months. The company is seeking Priority Review to potentially expedite the FDA's decision to six months. If approved, lovo-cel would become bluebird bio's third gene therapy for a rare genetic disorder. The FDA has previously granted several designations for lovo-cel, recognizing its potential impact on a significant patient population affected by SCD, a serious condition impacting 100,000 people in the U.S.

bluebird bio reported strong momentum in its commercial gene therapy initiatives for ZYNTEGLO and SKYSONA, with 7 patient starts to date. The company is advancing its Biologics License Application (BLA) for lovo-cel targeting sickle cell disease, with an anticipated FDA response soon. Financially, bluebird's Q4 2022 revenue was $0.06 million, down from $1.6 million in Q4 2021, while total revenue for 2022 was $3.6 million, slightly lower than the prior year. The company has a cash position of approximately $227 million but expects a cash burn between $270-$300 million for 2023. Despite losses, significant progress in therapies and operational efficiency was noted.

bluebird bio, Inc. (Nasdaq: BLUE) has priced an underwritten public offering of 20,000,000 shares of common stock at $6.00 per share, potentially raising gross proceeds of $120 million. The offering includes an option for underwriters to purchase an additional 3,000,000 shares. Funds will support commercialization and manufacturing of approved gene therapies ZYNTEGLO and SKYSONA, accelerate activities for the gene therapy candidate lovo-cel, and cover general corporate purposes. The offering is expected to close on or about January 23, 2023, pending customary conditions.

bluebird bio has initiated a public offering of 20 million shares of its common stock, with a possible additional 3 million shares available for underwriters. The offering's specifics depend on market conditions and completion is uncertain. The funds will support commercialization and manufacturing of its gene therapies, including ZYNTEGLO and SKYSONA, accelerate activities for lovotibeglogene autotemcel (lovo-cel) if approved, and cover working capital needs. The public offering is registered with the SEC under an effective shelf registration statement.

bluebird bio announced progress updates ahead of the J.P. Morgan Healthcare Conference, highlighting significant milestones in their commercial gene therapy launches. The first commercial treatment of ZYNTEGLO has begun, with expected revenue in Q1 2023. The company also confirmed that the lovo-cel BLA submission is on track for Q1 2023. As of December 31, 2022, bluebird reported approximately $182 million in cash and equivalents, projecting cash burn between $270-$300 million for 2023, which supports operations until Q1 2024.