bluebird bio, Inc. - BLUE STOCK NEWS

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.

bluebird bio, Inc. (NASDAQ: BLUE) has successfully sold its second Rare Pediatric Disease Priority Review Voucher (PRV) for $95 million, enhancing its financial strength without diluting shareholder equity. This follows a similar transaction last year where the company sold its first PRV for $102 million. The funds are expected to support the commercial launches of its FDA-approved gene therapies, ZYNTEGLO and SKYSONA, while bolstering the company's position in the sickle cell disease market.

bluebird bio (Nasdaq: BLUE) will present a corporate update at the 41^st Annual J.P. Morgan Healthcare Conference on January 12, 2023, at 7:30 AM PT. CEO Andrew Obenshain will lead the session. Investors can access the live webcast on the bluebird bio website, where a replay will be available for 30 days. bluebird bio focuses on curative gene therapies for severe genetic diseases, including sickle cell disease and β-thalassemia, and is known for its industry-leading data in ex-vivo gene therapy.

bluebird bio, Inc. (Nasdaq: BLUE) has appointed Joseph Vittiglio as Chief Business and Legal Officer. Vittiglio, who has over 20 years of biopharmaceutical experience, previously held executive roles at Finch Therapeutics and AMAG Pharmaceuticals. His expertise spans licensing, mergers, FDA regulations, and quality operations. This appointment aims to strengthen the management team as bluebird bio transitions into a commercial-stage company focused on delivering gene therapies for severe genetic diseases.

bluebird bio announced that the FDA has lifted its partial clinical hold on lovotibeglogene autotemcel (lovo-cel) for patients under 18 with sickle cell disease (SCD). The company plans to resume enrollment and treatment of pediatric patients in Q1 2023, following a thorough investigation into previous anemia cases related to the treatment. bluebird is on track to submit a Biologics License Application for lovo-cel by the end of Q1 2023, having met FDA requirements and updated exclusion criteria for ongoing trials.

bluebird bio presented updated data on its gene therapies for beta-thalassemia and sickle cell disease at the ASH Annual Meeting. Key findings for ZYNTEGLO (beti-cel) include 90.2% of beta-thalassemia patients achieving transfusion independence, with long-term follow-up showing durable treatment effects. Lovo-cel's data revealed two anemia cases linked to alpha-thalassemia trait. A BLA for lovo-cel is anticipated by Q1 2023. Safety profiles for both therapies were consistent with known side effects, and ongoing studies continue to advance understanding of treatment safety and efficacy.

bluebird bio announced a definitive agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV) for $102 million. The PRV was awarded due to FDA approvals of its gene therapies, ZYNTEGLO and SKYSONA, in 2022. CEO Andrew Obenshain stated that this non-dilutive capital strengthens the company's financial outlook, aiding the launches of these therapies and upcoming milestones, including a BLA submission for lovo-cel for sickle cell disease. The transaction, subject to closing conditions, marks a significant financial maneuver for the company.