Bluebird Bio Inc - BLUE STOCK NEWS

bluebird bio (NASDAQ: BLUE) has announced a definitive agreement to be acquired by Carlyle and SK Capital Partners. Under the deal terms, stockholders will receive $3.00 per share in cash plus a contingent value right of $6.84 per share, payable if the company achieves $600 million in net sales within any 12-month period ending by December 31, 2027.

The transaction comes after bluebird's Board conducted a comprehensive review of strategic alternatives, meeting with over 70 potential investors. The Board determined this was the only viable solution following financial challenges and a third FDA denial of their priority review voucher, with the company at risk of defaulting on loan covenants.

David Meek, former CEO of Mirati Therapeutics and Ipsen, will become CEO upon closing. The deal, expected to close in first half of 2025, will take bluebird private and aims to scale their commercial delivery of gene therapies for sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy.

bluebird bio (BLUE) presented long-term data for LYFGENIA™ gene therapy in sickle cell disease at ASH Annual Meeting. The study included 70 treated patients with up to 9 years of follow-up. Key findings show stable production of anti-sickling adult hemoglobin and significant reduction in vaso-occlusive events across all evaluable patients (n=38).

Notable results include 94.7% of evaluable patients achieving complete resolution of severe VOEs, and 86.8% achieving complete resolution of VOEs. All pediatric patients (10/10) showed complete resolution of VOEs. In patients with stroke history, no recurrence was observed through 9 years of follow-up.

The safety profile aligned with known effects of myeloablative conditioning, with no cases of graft failure or GVHD. However, two patients from an earlier version of the therapy developed acute myeloid leukemia and subsequently died.

bluebird bio (NASDAQ: BLUE) presented updated data for betibeglogene autotemcel (beti-cel/ZYNTEGLO™) in beta-thalassemia patients at the 66th ASH Annual Meeting. The long-term follow-up data, extending beyond 10 years in the earliest treated patients, demonstrates sustained treatment effects with 90.2% of Phase 3 and 68.2% of Phase 1/2 study participants achieving transfusion independence (TI).

Key findings include median weighted average hemoglobin of 10.2 mg/dL for Phase 1/2 and 11.2 mg/dL for Phase 3 studies. Among participants achieving TI, 75.7% no longer require iron chelation therapy. The safety profile remained consistent with known side effects, with no reports of malignancies or serious adverse events related to beti-cel after 2 years post-infusion.

bluebird bio (NASDAQ: BLUE) has announced a 1-for-20 reverse stock split following approval from both its Board of Directors and stockholders at the December 4, 2024 reconvened annual meeting. The primary goal is to increase the per-share market price to regain compliance with Nasdaq's minimum bid price requirement.

The reverse split will become effective on December 12, 2024, at 5 p.m. ET, with split-adjusted trading beginning December 13 under the same symbol 'BLUE'. Every 20 shares will be combined into 1 share, with cash payments issued for fractional shares. Stockholders with electronic holdings need not take action, while those holding shares through brokers will have positions adjusted automatically.

bluebird bio (NASDAQ: BLUE) has reached an agreement with the Center for Medicare and Medicaid Innovation (CMMI) to offer an outcomes-based agreement for LYFGENIA gene therapy under the Cell and Gene Therapy Access Model. The therapy is approved for sickle cell disease patients aged 12 and older with a history of vaso-occlusive events.

Currently, over half of all states have confirmed coverage for LYFGENIA, with more than 50% of Medicaid-insured sickle cell disease patients living in states that have approved at least one prior authorization. The model will enroll patients for 6 years, with individual patient tracking for 5 years. States have until February 28, 2025, to opt into the program, with participation beginning between January 2025 and January 2026.

bluebird bio (BLUE) reported Q3 2024 financial results with net revenue of $10.6 million, down from $12.3 million in Q3 2023. The company completed or scheduled 74 patient starts in 2024 across its portfolio, with 57 completed to date. Net loss improved to $60.8 million from $87.2 million year-over-year. Cash position stands at $118.7 million, including $48.0 million in restricted cash. The company expects to achieve quarterly cash flow break-even in H2 2025, contingent on scaling to approximately 40 drug product deliveries per quarter and securing additional funding. Management anticipates at least $25 million in net revenue for Q4 2024.

bluebird bio (NASDAQ: BLUE) has partially adjourned its annual stockholders meeting to December 4, 2024, specifically for Proposal 4, which seeks approval for a reverse stock split ranging from 1-for-15 to 1-for-20. The company faces potential Nasdaq delisting due to its current stock price and needs additional capital to reach cash flow breakeven in H2 2025. While stockholders approved Proposals 1, 2, 5, 6, and 7, and rejected Proposal 3, Proposal 4 requires over 50% approval of total outstanding shares. Despite current votes favoring the split approximately two to one, more votes are needed. The company will discuss Q3 2024 results on November 14, 2024.

bluebird bio (BLUE) will present new and updated data from its gene therapy programs at the 66th American Society of Hematology (ASH) Annual Meeting in December 2024. The presentations will showcase long-term follow-up data for treatments in sickle cell disease and beta-thalassemia.

Key highlights include updated data on lovo-cel, demonstrating consistent clinical outcomes from six months post-infusion, and the first focused sub-analysis of its impact on patients with stroke history. For beta-thalassemia, the company will present up to ten-year follow-up data showing durable transfusion independence and normal or near-normal hemoglobin levels in patients treated with beti-cel.

bluebird bio, Inc. (Nasdaq: BLUE) has announced the approval of inducement awards by the Compensation Committee of its Board of Directors. These awards include 242,500 restricted stock units (RSUs), with 100,000 RSUs granted to CFO James Sterling (grant date: September 30, 2024) and 142,500 RSUs granted to 19 other employees (grant date: October 1, 2024).

The Inducement Grants are subject to the terms of award agreements and the Company's 2021 Inducement Plan. The RSUs will vest equally over four years, with 25% vesting annually on the vesting date anniversary. These grants were made as inducement materials for new employees, including James Sterling, in accordance with NASDAQ Listing Rule 5635(c)(4).