SOMERVILLE, Mass. / Sep 13, 2024 / Business Wire / 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... Read More

SOMERVILLE, Mass. / Aug 28, 2024 / Business Wire / bluebird bio, Inc. (Nasdaq: BLUE) today announced that members of the management team will participate in fireside chats at the following upcoming investor conferences: 2024 Wells Fargo Healthcare Conference, Wednesday, September 4, at 12:45 p.m. ET at the Encore Boston Harbor, Everett, MA Morgan Stanley 22nd Annual Global Healthcare Conference, Thursday, September 5, at... Read More

SOMERVILLE, Mass. / Aug 23, 2024 / Business Wire / 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... Read More

27 patient starts to date in 2024 (19 ZYNTEGLO, 4 LYFGENIA, 4 SKYSONA); anticipate approximately 85 patient starts across the portfolio as LYFGENIA patient starts accelerate in the second half of 2024 Second quarter 2024 net revenue of $16.1 million Cash runway into Q2 2025 based on current operating plans and cash on hand Management to host conference call today, August 14, 2024 at 8:00 am ET SOMERVILLE, Mass. / Aug 14,... Read More

SOMERVILLE, Mass. / Aug 12, 2024 / Business Wire / 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. To participate in the conference call, please dial +1 (800) 715-9871 (U.S. and Canada) and ask to be joined into the bluebird call or provide the Conference ID 2776050. To access the live webcast,... Read More

SOMERVILLE, Mass. / Aug 02, 2024 / Business Wire / 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. The stock options approved under the Inducement Plan have an... Read More

SOMERVILLE, Mass. / Jul 03, 2024 / Business Wire / 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. The stock options approved under the Inducement Plan have an exercise price... Read More

SOMERVILLE, Mass. / May 29, 2024 / Business Wire / 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. “We are thrilled to welcome James to bluebird bio. We are confident that his... Read More

First patient start (cell collection) for LYFGENIA completed 15 patient starts to date in 2024 (11 ZYNTEGLO, 3 SKYSONA, 1 LYFGENIA); 85 to 105 patient starts anticipated across the portfolio in 2024 First quarter 2024 net revenue of $18.6 million Management to host conference call today, May 9, 2024 at 8:00 am ET SOMERVILLE, Mass. / May 09, 2024 / Business Wire / bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the... Read More

SOMERVILLE, Mass. / May 06, 2024 / Business Wire / 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. To participate in the conference call, please dial +1 (800) 715-9871 (U.S. and Canada) and ask to be joined into the bluebird call or provide the Conference ID 9768329. In addition, members of the... Read More

SOMERVILLE, Mass. / May 06, 2024 / Business Wire / 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... Read More

SOMERVILLE, Mass. / Apr 26, 2024 / Business Wire / 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”),... Read More

SOMERVILLE, Mass. / Apr 11, 2024 / Business Wire / 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... Read More

Cash runway through Q1 2026 following announcement of a $175 million term loan facility with Hercules Capital 9 patient starts to date in 2024 (7 ZYNTEGLO, 2 SKYSONA); 85 to 105 patient starts anticipated across the portfolio in 2024 First government outcomes-based agreement for sickle cell disease signed with Michigan Medicaid 62 qualified treatment centers (QTCs) activated Full year 2023 revenue of $29.5 million with $7.8... Read More

SOMERVILLE, Mass. / Mar 25, 2024 / Business Wire / 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. To access the live conference call via telephone, please register at this link to receive a dial in number and unique PIN. The live webcast of the call may be accessed by visiting the... Read More

Funding expected to extend the Company’s cash runway beyond the next 24 months First tranche of $75 million was drawn upon closing; the Company will be eligible to draw an additional $50 million subject to achievement of commercial milestones SOMERVILLE, Mass. / Mar 18, 2024 / Business Wire / bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today announced that it has entered into a $175 million five-year,... Read More

SOMERVILLE, Mass. / Mar 11, 2024 / Business Wire / bluebird bio, Inc. (NASDAQ: BLUE) (“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... Read More

Significant momentum behind LYFGENIA launch with 35 Qualified Treatment Centers accepting patient referrals and payer agreements in place covering approximately 200 million U.S. lives Anticipate 85 to 105 patient starts (cell collections) across commercial portfolio in 2024 with first patient start for LYFGENIA expected in Q1 2024 Cash, cash equivalents and marketable securities expected to fund current operations into Q1... Read More

SOMERVILLE, Mass. / Jan 02, 2024 / Business Wire / bluebird bio, Inc. (Nasdaq: BLUE) today announced that Andrew Obenshain, chief executive officer, bluebird bio, will present a corporate update at the 42 nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 10:30am PT/1:30pm ET. To access the live webcast of bluebird bio’s presentation, please visit the “Events & Presentations” page within the... Read More

SOMERVILLE, Mass. / Dec 19, 2023 / Business Wire / 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... Read More

SOMERVILLE, Mass. / Dec 18, 2023 / Business Wire / 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... Read More

Updated data from studies of beti-cel in 63 patients with transfusion-dependent beta-thalassemia showed sustained transfusion independence and improvements in iron management through up to 9 years of follow-up (n=1) All four parent studies are complete, and all patients have transitioned to a long-term follow-up study (LTF-303) beti-cel is U.S. Food and Drug Administration (FDA) approved and marketed in the U.S. as ZYNTEGLO... Read More

Oral presentation to include data on 47 patients through five years of follow-up (median 35.5 months, range 0.3-61 months) Endpoints of sVOE-CR and VOE-CR achieved in 94% (32/34) and 88% (30/34) of evaluable patients respectively 100% of adolescents (10/10) experienced complete resolution of VOEs and sVOEs, providing evidence of potential benefit for this population Impact on hemolysis markers and health-related quality of... Read More

Outcomes-based contract offerings available to both commercial payers and Medicaid LYFGENIA will be available through bluebird’s established national network of Qualified Treatment Centers beginning in Q1 2024 “my bluebird support” patient services program will provide personalized support for patients and their families throughout their treatment journey Price of LYFGENIA reflects its value as a potentially curative gene... Read More

Severe vaso-occlusive events were eliminated for 94% (30/32) of evaluable patients and all VOEs were eliminated for 88% (28/32) of evaluable patients between 6 and 18 months post-infusion LYFGENIA is the most deeply studied gene therapy for sickle cell disease with the most patients treated and longest follow-up Management to host conference call today, December 8, 2023, at 4:15 p.m. ET SOMERVILLE, Mass. / Dec 08, 2023 /... Read More

Continued strong commercial launch for ZYNTEGLO ® and SKYSONA ® ; 22 patient starts across both programs to date Ended quarter with $227M in cash, cash equivalents, marketable securities and restricted cash Company entered into advance agreement to sell priority review voucher, if granted, for $103 million; potential non-dilutive capital would strengthen cash position Management to host conference call today at 8:00AM ET... Read More

Oral presentation details efficacy, safety and health-related quality of life data in adult and pediatric patients with sickle cell disease treated with lovo-cel in HGB-206 Group C and HGB-210 (n=47) through 5 years of follow-up (n=4) Updated long-term efficacy, safety, quality of life data and iron management outcomes from adult and pediatric patients with transfusion-dependent beta-thalassemia (n=63) treated with beti-cel... Read More

Non-dilutive capital would strengthen Company’s financial position SOMERVILLE, Mass. / Oct 30, 2023 / Business Wire / bluebird bio, Inc. (NASDAQ: BLUE) (“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.... Read More

SOMERVILLE, Mass. / Oct 24, 2023 / Business Wire / 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. To access the call via telephone, please register at this link https://edge.media-server.com/mmc/p/cq4tzukh to receive a dial in number and unique PIN to access the live conference... Read More

SOMERVILLE, Mass. / Sep 05, 2023 / Business Wire / bluebird bio, Inc. (Nasdaq: BLUE) today announced that members of the management team will participate in fireside chats at the following upcoming investor conferences: Morgan Stanley 21 st Annual Global Healthcare Conference, Monday, September 11, at 12:15 p.m. ET at the Sheraton, New York, NY Baird 2023 Global Healthcare Conference, Tuesday, September 12, at 2:00 p.m. ET... Read More

SOMERVILLE, Mass. / Aug 16, 2023 / Business Wire / 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... Read More

Continued strong commercial launch for ZYNTEGLO ® and SKYSONA ® ; 16 patient starts across both programs to date Biologics License Application (BLA) for lovo-cel for sickle cell disease accepted for FDA priority review; PDUFA goal date December 20, 2023 Ended quarter with $291M in cash, cash equivalents, marketable securities and restricted cash Management to host conference call on Q2 earnings and commercial launch progress... Read More

SOMERVILLE, Mass. / Jul 25, 2023 / Business Wire / 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... Read More

BLA submission based on data from the largest and most mature clinical development program for any gene therapy in sickle cell disease PDUFA date set for December 20, 2023 SOMERVILLE, Mass. / Jun 21, 2023 / Business Wire / 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... Read More

Biologics License Application (BLA) for lovo-cel for sickle cell disease submitted to FDA First commercial infusions completed for both ZYNTEGLO ® and SKYSONA ® Ended quarter with $364M in cash, cash equivalents, marketable securities and restricted cash SOMERVILLE, Mass. / May 09, 2023 / Business Wire / bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today reported financial results and business... Read More

SOMERVILLE, Mass. / Apr 27, 2023 / Business Wire / bluebird bio, Inc . (Nasdaq: BLUE) today announced that the Company’s first quarter financial results, including commercial, regulatory and operational updates, will be released pre-market on Tuesday, May 9. In addition, members of the management team will participate in the following upcoming investor conferences: BofA Securities 2023 Health Care Conference, Thursday, May... Read More

BLA submission based on data from the largest and most mature clinical development program for any gene therapy in sickle cell disease SOMERVILLE, Mass. / Apr 24, 2023 / Business Wire / 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... Read More

Continued strong commercial launch for ZYNTEGLO® and SKYSONA®; 7 patient starts (cell collections) across both programs to date Update on Biologics License Application (BLA) submission for lovo-cel for sickle cell disease (SCD) Management to host conference call today, March 29, 2023 at 8:00AM ET SOMERVILLE, Mass. / Mar 29, 2023 / Business Wire / bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio” or the “Company”) today... Read More

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... Read More

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... Read More

First commercially treated ZYNTEGLO patient apheresed in Q4 2022; first revenue anticipated in Q1 2023 lovo-cel BLA submission on track for Q1 2023; vector and drug product analytical comparability studies complete Company enters 2023 with cash runway into Q1 2024 bluebird bio, Inc . (Nasdaq: BLUE) (the Company) today announced updates to be presented at the 41 st Annual J.P. Morgan Healthcare conference including commercial... Read More

Non-dilutive capital further strengthens Company’s financial position bluebird bio, Inc. (NASDAQ: BLUE) (“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 was granted two PRVs upon the US Food and Drug Administration (FDA) approvals of ZYNTEGLO® (betibeglogene autotemcel) for... Read More

bluebird bio, Inc . (Nasdaq: BLUE) today announced that Andrew Obenshain, chief executive officer, bluebird bio, will present a corporate update at the 41 st Annual J.P. Morgan Healthcare Conference on Thursday, January 12, 2023, at 7:30AM PT. To access the live webcast of bluebird bio’s presentation, please visit the “Events & Presentations” page within the Investors & Media section of the bluebird bio website at... Read More

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.... Read More

Findings from clinical studies (N=63) through eight years of long-term follow-up (n=3) continue to support ZYNTEGLO as a potentially curative one-time gene therapy for patients with beta-thalassemia who require regular red blood cell (RBC) transfusions through the achievement of durable transfusion independence and normal or near normal total hemoglobin levels Detailed investigations affirm that two cases of anemia in... Read More