Articles from bluebird bio, Inc.

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.

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).

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.

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”).

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”).

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

bluebird bio, Inc. (Nasdaq: BLUE) announced today that it will host a conference call to discuss second quarter 2024 results and business updates on August 14, at 8:00 a.m. ET.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Compensation Committee of the Company’s Board of Directors approved an inducement grant of stock options to purchase a total of 38,200 shares of common stock to its controller and vice president of accounting, Joe Ewer, with a grant date of August 1, 2024.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Compensation Committee of the Company’s Board of Directors approved an inducement grant of stock options to purchase a total of 300,000 shares of common stock to its chief financial officer, James Sterling, with a grant date of July 1, 2024.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that O. James Sterling, has been appointed chief financial officer (CFO), effective June 10, 2024. Mr. Sterling most recently served as chief financial officer of Renalytix plc, a diagnostics company focused on clinical management of kidney disease.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported first quarter results and business highlights for the quarter ended March 31, 2024, including recent commercial and operational progress.

bluebird bio, Inc. (Nasdaq: BLUE) announced today that it will host a conference call to discuss first quarter 2024 results and business updates on May 9, at 8:00 a.m. ET.

bluebird bio, Inc. (Nasdaq: BLUE) announced today that it has completed the first commercial cell collection for LYFGENIA (lovotibeglogene autotemcel), a one-time gene therapy for the treatment of sickle cell disease in patients with a history of vaso-occlusive events. LYFGENIA was approved by the FDA in December 2023 and is the most deeply studied gene therapy for sickle cell disease, with the longest follow-up in the field.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that it received a notice (the “notice”) on April 24, 2024 from The Nasdaq Stock Market LLC (“Nasdaq”) stating that because the Company has not yet filed its Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K"), it is no longer 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”).

bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Compensation Committee of the Company’s Board of Directors approved inducement grants of 102,700 restricted stock units (“RSUs”) to twelve newly hired employees with a grant date of April 9, 2024 (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. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported fourth quarter and annual financial results and business highlights for the year ended December 31, 2023, including recent commercial and operational progress.

bluebird bio, Inc. (Nasdaq: BLUE) announced today that it will host a conference call to discuss fourth quarter and 2023 annual results and business updates on March 26, 2024, at 8:00 a.m. ET.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today announced that it has entered into a $175 million five-year, term loan facility with Hercules Capital, Inc. NYSE: HTGCNYSEHTGC)

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio”) today announced it has signed its first Medicaid outcomes-based agreement for LYFGENIA™ (lovotibeglogene autotemcel, also known as lovo-cel) with the state of Michigan. 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). Approximately 50 percent of individuals living with sickle cell disease in the U.S. are insured by Medicaid.

bluebird bio, Inc. (Nasdaq: BLUE) (the Company; bluebird) today announced updates to be presented at the 42nd Annual J.P. Morgan Healthcare conference including commercial launch progress, 2024 program milestones and financial outlook. Andrew Obenshain, chief executive officer, is scheduled to present Tuesday, January 9 at 10:30 a.m. PT/1:30 p.m. ET.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that Andrew Obenshain, chief executive officer, bluebird bio, will present a corporate update at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 10:30am PT/1:30pm ET.

bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird”) today announced the pricing of its underwritten public offering of 83,333,333 shares of its common stock at a public offering price of $1.50 per share, before deducting underwriting discounts and commissions. bluebird also granted the underwriters a 30-day option to purchase up to an additional 12,499,999 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The gross proceeds from the public offering are expected be $125 million, before deducting underwriting discounts and commissions and offering expenses payable by bluebird and assuming no exercise of the underwriters’ option to purchase additional shares of common stock. All shares in the offering are to be sold by bluebird.

bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird”) today announced that it has commenced an underwritten public offering of $150,000,000 of shares of its common stock. bluebird also intends to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares of its common stock to be sold in the offering. The offering, actual size and terms are subject to market conditions, and there can be no assurance as to whether or when the offering may be completed. All shares in the offering are to be sold by bluebird.

Updated data from bluebird bio inc.’s (NASDAQBLUE) gene therapy program in transfusion-dependent (TDT) beta-thalassemia were presented today at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition. Updated follow-up data showed sustained treatment effect, reduced iron management burden and improved quality of life measures in patients with beta-thalassemia who require regular red blood cell transfusions following treatment with betibeglogene autotemcel (beti-cel) (FDA approved and marketed in the U.S. as ZYNTEGLO™).

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or “bluebird”) today announced new and updated efficacy, safety and health-related quality of life (HRQoL) data from the Phase 1/2 HGB-206 Group C and Phase 3 HGB-210 studies of lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease through five years of follow-up (median 35.5 months, range 0.3-61 months). Data were highlighted in a press briefing at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition and will be presented in an oral presentation on Monday, December 11, 2023 at 4:30 p.m. Pacific Time.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “bluebird”) today announced the details of its U.S. commercial infrastructure to support timely, equitable access to LYFGENIA™ (lovotibeglogene autotemcel, also known as lovo-cel), an FDA-approved gene therapy for the treatment of patients 12 years of age and older with sickle cell disease and a history of vaso-occlusive events (VOEs). The LYFGENIA launch builds on bluebird’s demonstrated success delivering ex vivo gene therapies to patients in the United States and includes outcomes-based contract offerings for payers, as well as a personalized patient support program.

bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird bio” or “bluebird”) today announced the U.S. Food and Drug Administration (FDA) has approved LYFGENIA™ (pronounced as ‘lif-JEN-ee-uh’) (lovotibeglogene autotemcel), also known as lovo-cel, for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events (VOEs). LYFGENIA is a one-time gene therapy that has the potential to resolve vaso-occlusive events and is custom-designed to treat the underlying cause of sickle cell disease.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the third quarter ended September 30, 2023, including recent commercial and operational progress, and regulatory updates.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that new long-term efficacy, safety and health-related quality of life (HRQoL) follow-up data from its lentiviral vector (LVV) gene therapy programs in patients with sickle cell disease who have a history of vaso-occlusive events and patients with beta-thalassemia who require regular red blood cell transfusions will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will take place December 9-12, 2023 at the San Diego Convention Center and online.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today announced that it has entered into an agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV), if received, in connection with the potential approval of lovotibeglogene autotemcel (lovo-cel) for sickle cell disease. Under the terms of the agreement, rights to the PRV will transfer to the buyer and the Company will receive $103 million upon closing of the sale, which is contingent upon the U.S. Food and Drug Administration’s (FDA’s) approval of the biologics license application (BLA) for lovo-cel and granting of the PRV.

bluebird bio, Inc. (Nasdaq: BLUE) announced today that it will host a conference call to discuss third quarter 2023 financial results and business updates on Tuesday, November 7 at 8:00 a.m. ET.

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 the U.S. Food and Drug Administration (FDA) has communicated that an advisory committee meeting will not be scheduled for lovotibeglogene autotemcel (lovo-cel). Lovo-cel is a potentially transformative one-time gene therapy for individuals living with sickle cell disease (SCD) with a proposed indication for patients ages 12 and older who have a history of vaso-occlusive events (VOEs). The Agency previously accepted the lovo-cel Biologics Licensing Application (BLA) for Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the second quarter ended June 30, 2023, including recent commercial and operational progress, and regulatory updates.

bluebird bio, Inc. (Nasdaq: BLUE) today announced it will hold a conference call to discuss second quarter 2023 financial results and provide a commercial update on Tuesday, August 8 at 8:00 a.m. ET. In addition to providing an overview of the business, the conference call will highlight the Company’s ongoing commercial launches of SKYSONA® and ZYNTEGLO® and the market opportunity for lovo-cel.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review. Lovo-cel is a potentially transformative one-time gene therapy for individuals living with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events (VOEs). It is specifically designed to treat the underlying cause of SCD through the addition of a functional gene that enables production of anti-sickling adult hemoglobin and is the most deeply studied gene therapy in development for this disease. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the first quarter ended March 31, 2023, including recent commercial and operational progress, and regulatory updates.

bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lovotibeglogene autotemcel (lovo-cel) gene therapy in patients with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events (VOEs). The BLA includes a request for Priority Review, which, if granted, would shorten the FDA’s review of the application to six months from the time of filing, versus a standard review timeline of 10 months. If approved, lovo-cel will be bluebird bio’s third ex-vivo gene therapy approved by the FDA for a rare genetic disease and its second FDA approval for an inherited hemoglobin disorder, building on more than a decade of leadership in gene therapy.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the fourth quarter and full year ended December 31, 2022 including recent commercial and operational progress, and regulatory updates.

bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird”) today announced the pricing of its underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $6.00 per share, before deducting underwriting discounts and commissions. bluebird also granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The gross proceeds from the public offering are expected be $120 million, before deducting underwriting discounts and commissions and offering expenses payable by bluebird and assuming no exercise of the underwriters’ option to purchase additional shares of common stock. All shares in the offering are to be sold by bluebird.

bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird”) today announced that it has commenced an underwritten public offering of 20,000,000 shares of its common stock. bluebird also intends to grant the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of its common stock to be sold in the offering. The offering, actual size and terms are subject to market conditions, and there can be no assurance as to whether or when the offering may be completed. All shares in the offering are to be sold by bluebird.

bluebird bio, Inc. (Nasdaq: BLUE) (the Company) today announced updates to be presented at the 41st Annual J.P. Morgan Healthcare conference including commercial launch progress, 2023 program milestones and financial outlook. CEO Andrew Obenshain is scheduled to speak on Thursday, January 12 at 7:30 a.m. PT.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today announced that it has entered into a definitive agreement to sell its second Rare Pediatric Disease Priority Review Voucher (PRV) for $95 million.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that Andrew Obenshain, chief executive officer, bluebird bio, will present a corporate update at the 41st Annual J.P. Morgan Healthcare Conference on Thursday, January 12, 2023, at 7:30AM PT.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that Joseph Vittiglio, JD, has been appointed Chief Business and Legal Officer. Vittiglio brings more than 20 years of experience in the biopharmaceutical industry, with expertise in licensing, collaborations and mergers and acquisitions, financial transactions, FDA regulations, compliance, manufacturing, and quality operations for organizations at all stages of development.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) lifted its partial clinical hold for patients under the age of 18 in studies evaluating lovotibeglogene autotemcel (lovo-cel) for sickle cell disease (SCD).

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today announced that it has entered into a definitive agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV) for $102 million.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the third quarter ended September 30, 2022 and shared recent operational progress.

bluebird bio, Inc. (NASDAQBLUE) today announced that members of the management team will participate in the 31st Annual Credit Suisse Healthcare Conference, Tuesday, November 8, at 5:00 p.m. PT at the Terranea Resort, Rancho Palos Verdes, CA.

bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has granted Accelerated Approval of SKYSONA® (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). The Company also confirmed that the previous clinical hold on the eli-cel clinical development program has been lifted.

bluebird bio, Inc. (NASDAQBLUE) today announced that Jason Cole, Chief Strategy and Financial Officer, plans to leave bluebird bio to pursue new career opportunities.​

bluebird bio, Inc. (NASDAQBLUE) today announced that members of the management team will participate in the following upcoming investor conferences:

Following the FDA approval of ZYNTEGLO® (betibeglogene autotemcel), also known as beti-cel, for the treatment of beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions, today bluebird bio released details of its U.S. commercial infrastructure to support rapid access to ZYNTEGLO, including an innovative, outcomes-based contract offering and a comprehensive patient support program.

bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO® (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the second quarter ended June 30, 2022, and shared recent operational progress.

bluebird bio, Inc. (Nasdaq: BLUE) today announced the outcome of the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) discussion of betibeglogene autotemcel (beti-cel) for the treatment of people with beta-thalassemia who require regular red blood cell (RBC) transfusions.

bluebird bio, Inc. (Nasdaq: BLUE) today announced the outcome of the U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) discussion of elivaldogene autotemcel (eli-cel) for the treatment of early active cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age who do not have an available and willing human leukocyte antigen (HLA)-matched sibling hematopoietic stem cell (HSC) donor.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today announced that Nasdaq has halted trading of the company’s common stock on Thursday, June 9 and Friday, June 10, 2022. The U.S. Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) is meeting to discuss the biologics licensing applications (BLAs) for betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel).

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the FDA Cellular, Tissue and Gene Therapies Advisory Committee Meeting to review elivaldogene autotemcel (eli-cel) for early active cerebral adrenoleukodystrophy (CALD) in patients without a matched sibling donor and betibeglogene autotemcel (beti-cel) for the treatment of people with β-thalassemia who require regular red blood cell transfusions.

bluebird bio, Inc. (NASDAQBLUE) (“bluebird bio” or the “Company”) today reported financial results and business highlights for the first quarter ended March 31, 2022, and shared recent operational progress.

Following a review of its strategic priorities, bluebird bio, Inc. (Nasdaq: BLUE) today announced that the Company is initiating a comprehensive restructuring intended to deliver up to $160 million in cost savings over the next two years.

bluebird bio, Inc. (NASDAQBLUE) today announced that the US Food and Drug Administration (FDA) has extended the review period for the biologics licensing applications (BLA) for its lentiviral vector gene therapies – betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD). The revised PDUFA goal dates for beti-cel and eli-cel are August 19, 2022 and September 16, 2022, respectively.

bluebird bio, Inc. (Nasdaq: BLUE) today announced planned updates to be presented at the 40th Annual J.P. Morgan Healthcare conference including 2022 program milestones and financial outlook.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that members of the management team will present at the virtual 40th Annual J.P. Morgan Healthcare Conference, Wednesday, January 12, at 3:45 p.m. ET.

bluebird bio, Inc. (NASDAQBLUE) today announced that the FDA has placed its clinical program for lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease (SCD) on partial clinical hold for patients under the age of 18. The partial, temporary suspension relates to an ongoing investigation by bluebird bio into an adolescent patient with persistent, non-transfusion-dependent anemia following treatment with lovo-cel, now 18 months post-treatment. This patient is clinically well and there is no evidence of malignancy or clonal predominance. Enrollment and dosing for patients 18 and older living with SCD in the HGB-206, HGB-210 and LTF-307 clinical studies, as well as follow up for treated patients of all ages in all studies are continuing as planned.

bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for elivaldogene autotemcel (eli-cel, Lenti-D®), the company’s gene therapy for cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age. Eli-cel is an investigational one-time gene therapy, custom-designed to treat the underlying cause of this irreversible neurodegenerative disease and to stabilize neurologic function. The agency set a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2022.

bluebird bio, Inc. (NASDAQBLUE) today announced updated results from its Phase 1/2 HGB-206 study of lovotibeglogene autotemcel (lovo-cel; formerly LentiGlobin® for SCD, bb1111) gene therapy for sickle cell disease, including further analyses from its pivotal cohort, HGB-206 Group C, following enhancements to the manufacturing protocols and treatment process. In addition to continued complete resolution of severe vaso-occlusive events (VOEs), patients in Group C achieved near normal levels of key hemolysis markers and experienced sustained improvements in patient-reported quality of life following treatment. Data were presented in two oral sessions at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 11-14, 2021, at the Georgia World Congress Center in Atlanta and virtually; select data from the Group C cohort of the HGB-206 study were simultaneously published in The New England Journal of Medicine (NEJM).