bluebird bio, Inc. (Nasdaq: BLUE) today announced new and updated data from LYFGENIA™ (lovotobegligene autotemcel, or lovo-cel) gene therapy for patients with sickle cell disease who have a history of vaso-occlusive events (VOEs). The data will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in an oral presentation on Sunday, December 8 at 9:30 a.m. Pacific Time and a poster presentation on Sunday, December 8 at 6 p.m. Pacific Time. As of July 2024, 70 patients were treated across the full lovo-cel clinical development program, with follow-up beyond 9 years in the earliest treated patients.

bluebird bio, Inc. (Nasdaq: BLUE) today announced updated data from patients with beta-thalassemia who require regular blood transfusions treated with betibeglogene autotemcel (beti-cel, approved commercially as ZYNTEGLO™) in clinical studies. The data was presented today at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today announced that it will proceed with a 1-for-20 reverse stock split (“Reverse Stock Split”) of the Company’s common stock following approval by both its Board of Directors and BLUE stockholders at its reconvened annual meeting held on December 4, 2024. As previously announced, the primary goal of the Reverse Stock Split is to increase the per share market price of the Company’s common stock to regain compliance with Nasdaq’s minimum bid price requirement for continued listing.

CMS launches an outcomes-based model to expand access to FDA-approved gene therapies for sickle cell disease, aiming to improve health outcomes and lower costs.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio”) today announced it has reached an agreement with the Center for Medicare and Medicaid Innovation to offer an outcomes-based agreement for LYFGENIA gene therapy under the Cell and Gene Therapy (CGT) Access Model. LYFGENIA is a one-time gene therapy approved for the treatment of patients 12 years of age and older with sickle cell disease and a history of vaso-occlusive events (VOEs).

The FDA is investigating reports of life-threatening blood cancers linked to Skysona, a gene therapy for CALD. Providers are urged to consider safer alternatives and monitor patients for malignancies.

Bluebird Bio's Q3 earnings report showed a narrower-than-expected EPS loss but missed sales targets, leading to a JP Morgan downgrade and cash concerns.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported third quarter results and business highlights for the quarter ended September 30, 2024, including recent commercial and operational progress.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today announced that it partially adjourned its annual meeting of stockholders (“Annual Meeting”) on Wednesday, November 6, 2024, to allow the Company to solicit additional votes to obtain approval of Proposal 4, a reverse stock split, as described in the Company's definitive proxy statement filed with the Securities and Exchange Commission on September 26, 2024 (the “proxy statement”). The Company’s stockholders approved Proposals 1, 2, 5, 6 and 7, and did not approve Proposal 3 during the Annual Meeting held earlier today (all proposals as described in the proxy statement). The Annual Meeting will reconvene on December 4, 2024, solely with respect to Proposal 4, beginning at 8:30 AM ET at the Company’s offices at 455 Grand Union Boulevard, Somerville, MA. The record date as of the close of business on September 16, 2024, remains unchanged for the determination of stockholders of the Company entitled to vote at the reconvened Annual Meeting.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that new and updated data from its lentiviral vector (LVV) gene addition programs in patients with sickle cell disease who have a history of vaso-occlusive events and patients with beta-thalassemia who require regular blood transfusions will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will take place December 7-10, 2024 at the San Diego Convention Center and online.

A recent report reveals an increase in cancer cases among children treated with Bluebird Bio's Skysona gene therapy, raising concerns about the therapy's safety. Seven children in clinical trials have developed blood cancers, with one tragic death reported.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Compensation Committee of the Company’s Board of Directors approved the grant of inducement awards of 242,500 restricted stock units (RSUs). This includes the previously disclosed 100,000 RSUs granted to the Company’s CFO, James Sterling, with a grant date of September 30, 2024 and 142,500 RSUs granted to 19 other employees, with a grant date of October 1, 2024 (collectively, the “Inducement Grants”). The Inducement Grants are subject to the terms and conditions of award agreements covering the grants and the Company’s 2021 Inducement Plan.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that it has completed the filing of its Form 10-Q for the quarter ended June 30, 2024 (the “Q2 2024 Form 10-Q”) with the Securities and Exchange Commission (“SEC”).

Pfizer stock dipped Thursday after the company voluntarily pulled its sickle cell drug, Oxbryta, from the market following patient deaths.

Bluebird bio announces restructuring plans to reduce costs by 20% and achieve cash flow break-even by late 2025. The initiative includes a 25% workforce reduction and focuses on advancing key gene therapy launches like LYFGENIA, ZYNTEGLO, and SKYSONA.

Following a comprehensive review of its operations, bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Company is implementing a restructuring intended to optimize the Company’s cost structure and enable quarterly cash flow break-even in the second half of 2025. The restructuring is expected to result in a 20% reduction in cash operating expenses when fully realized in Q3 2025, compared to the prior reporting period. The initiative includes a reduction in the Company’s workforce of approximately 25%. The Company’s cash flow break-even target assumes scaling to approximately 40 drug product deliveries per quarter, realizing the 20% reduction in cash operating expenses, and obtaining additional cash resources to extend the Company’s cash runway.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that it has completed the restatement of its consolidated financial statements for the year ended December 31, 2022, and for each of the first three quarters of 2022 and 2023. Today, the Company filed its Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K”), including the restated information, and Form 10-Q for the quarter ended March 31, 2024 (the “Q1 2024 Form 10-Q”) with the Securities and Exchange Commission (“SEC”).

bluebird bio, Inc. (Nasdaq: BLUE) today announced that members of the management team will participate in fireside chats at the following upcoming investor conferences:

bluebird bio, Inc. (Nasdaq: BLUE) today announced that it received notices (the “notices”) on August 20, 2024 from The Nasdaq Stock Market LLC (“Nasdaq”) stating that because the Company has not yet filed its Quarterly Reports on Form 10-Q for each of the quarters ended March 31, 2024 (the “Q1 2024 Form 10-Q”) and June 30, 2024 (the “Q2 2024 Form 10-Q”), it is not in compliance with Nasdaq Listing Rule 5250(c)(1) (the “Rule”), which requires listed companies to timely file all required periodic financial reports with the Securities and Exchange Commission (the “SEC”).