bluebird bio, Inc. - BLUE STOCK NEWS

2seventy bio, the upcoming oncology spin-off from bluebird bio (NASDAQ: BLUE), has announced a series of investor events to discuss its research pipeline and strategic direction. The first session, scheduled for September 21, 2021, will focus on AML [DARIC33] and their next-gen multiple myeloma strategy. The second session will take place on September 22, 2021, highlighting bNHL [bbT369] and solid tumor strategies. Investors can access live webcasts and recordings for 90 days post-event via the bluebird bio website.

bluebird bio announced a $75 million private placement of common stock and equivalents to fund ongoing R&D and commercialization efforts for itself and upcoming independent company 2seventy bio. The separation is scheduled for October 2021, with an additional $900 million cash expected at that time. Completion of the placement hinges on customary conditions, with closing anticipated in September 2021.

bluebird bio announces key appointments and upcoming investor events ahead of its planned separation, targeted for mid-October 2021. Gina Consylman joins as Chief Financial Officer, bringing over 25 years of expertise, while Marcela Maus is appointed to the board of directors, enhancing the leadership team. Investor conferences will occur in September, featuring participation from both bluebird bio and 2seventy bio.

bluebird bio (NASDAQ: BLUE) reported its Q2 2021 results, revealing a net loss of $241.7 million, a significant increase compared to $21.5 million from Q2 2020. Total revenues plummeted to $7.5 million from $198.9 million year-over-year, largely due to adjustments from a prior BMS contract. The FDA has placed a clinical hold on the eli-cel gene therapy program, affecting timelines for its submission. However, the company remains on track with its ABECMA launch, generating $24 million in U.S. revenues and anticipates cash reserves of approximately $900 million post-separation of its businesses, expected by year-end 2021.

bluebird bio, Inc. (NASDAQ: BLUE) will report its Q2 2021 financial results on August 9, 2021, followed by a conference call at 8 a.m. ET. Investors can access the call by dialing (844) 825-4408 or +1 (315) 625-3227 for international calls. The company will also participate in the Wedbush PacGrow Healthcare Conference on August 11 at 12:00 p.m. ET. bluebird bio focuses on gene therapies for severe genetic diseases and cancer, aiming to provide treatment options for patients with critical needs.

bluebird bio, Inc. (NASDAQ: BLUE) has approved inducement grants for a newly hired employee, consisting of stock options for 85,000 shares and 50,000 restricted stock units (RSUs), effective August 2, 2021. The stock options have an exercise price of $25.60, vesting over four years, with 25% vesting on the first anniversary and 1/36 monthly thereafter. The RSUs similarly vest over four years with 25% at the end of the first year. This action complies with NASDAQ Listing Rule 5635(c)(4) and reflects the company's commitment to attract talent in gene therapy development.

bluebird bio, Inc. (NASDAQ: BLUE) announced a strategic alliance with National Resilience, Inc. to enhance cell therapy manufacturing. Resilience will acquire bluebird’s Research Triangle facility for $110 million, retaining over 100 employees and ensuring ongoing supply of lentiviral vector (LVV) for their therapies. This partnership allows for shared expenses and revenue for oncology products, while expanding manufacturing capabilities. The deal is subject to regulatory approvals and aims to bolster innovation in gene therapy development.

bluebird bio (Nasdaq: BLUE) received marketing authorization from the European Commission for SKYSONA™ (elivaldogene autotemcel), the first gene therapy approved in the EU for treating early cerebral adrenoleukodystrophy (CALD) in patients under 18 without a matched sibling donor. This therapy targets the ABCD1 genetic mutation, critical for halting the progression of a disease that can lead to severe neurological decline. The approval covers all 27 EU member states and follows a rigorous clinical development program demonstrating significant efficacy.

bluebird bio (Nasdaq: BLUE) announced that the EMA's Pharmacovigilance Risk Assessment Committee has deemed the benefit-risk balance of ZYNTEGLO™ favorable, lifting the voluntary marketing suspension. The company emphasizes patient safety and expresses gratitude for the PRAC's review, enabling ZYNTEGLO to be offered again to those with transfusion-dependent β-thalassemia. No hematologic malignancies have been reported in treated patients. FDA has also lifted clinical holds on related studies. The company aims to submit a BLA for ZYNTEGLO by mid-2021.