• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Dashboard
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlerts
    Company
    AboutQuantisnow PlusContactJobs
    Legal
    Terms of usePrivacy policyCookie policy

    bluebird bio Reports Fourth Quarter and Full Year 2021 Financial Results, Highlights Operational Progress and Provides Corporate Update

    3/4/22 4:31:00 PM ET
    $BLUE
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $BLUE alert in real time by email

    - The Company's first two gene therapies, beti-cel for β-thalassemia and eli-cel for cerebral adrenoleukodystrophy, under review by the FDA -

    - lovo-cel BLA submission for sickle cell disease remains on track for Q1 2023 -

    - Ended year with $442M in restricted cash, cash and cash equivalents and marketable securities -

    bluebird bio, Inc. (NASDAQ:BLUE) ("bluebird bio" or the "Company") today reported financial results and business highlights for the fourth quarter and full year ended December 31, 2021, shared recent operational progress, and provided a corporate update.

    "2022 is set up to be a landmark year for bluebird bio, with LVV gene therapies for β-thalassemia and cerebral adrenoleukodystrophy under review by the U.S. Food and Drug Administration (FDA) and plans to submit a Biologics License Application (BLA) for lovo-cel for sickle cell disease (SCD) early next year," said Andrew Obenshain, CEO, bluebird bio. "Underscoring these significant milestones is a continued focus on commercialization and financial discipline to enable the delivery of these transformative therapies to patients and their families."

    RECENT HIGHLIGHTS

    LOVO-CEL

    • UPDATE ON PARTIAL CLINICAL HOLD FOR PATIENTS UNDER THE AGE OF 18 – Today, bluebird bio provided an update on the FDA's partial clinical hold for the lovotibeglogene autotemcel (lovo-cel) gene therapy clinical program for patients under the age of 18 with SCD. As previously communicated, in January 2022, bluebird bio received questions from the FDA related to the partial clinical hold. Following review of the questions from the FDA and an assessment of the timeline for manufacturing drug product lots and collecting analytical comparability data in the HGB-210 study, bluebird bio is reaffirming plans to submit the BLA for lovo-cel in Q1 2023. The Company continues to work with regulators to resume treating patients under the age of 18. In the meantime, the Company is collecting comparability data from drug product lots manufactured for adult patients in the HGB-210 study. As previously communicated, bluebird bio has treated all patients in HGB-206 Group C who will form the primary basis of efficacy for BLA submission, with the demonstration of analytical comparability and validation of the Company's commercial manufacturing process as the key remaining actions prior to submission of the planned BLA.
    • HGB-206 FINAL INFUSION – Today, bluebird bio announced the completion of the final patient infusion in the HGB-206 study, the ongoing Phase 1/2 open-label study designed to evaluate the efficacy and safety of lovo-cel for sickle cell disease. A total of 45 patients have been treated with lovo-cel in the HGB-206 study across three treatment cohorts: Groups A (n=7), B (n=2) and C (n=36).
    • DATA AT ASH AND PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE – On December 12, 2021, at the 63rd American Society of Hematology (ASH) Annual Meeting, bluebird bio presented new data showing a complete elimination of severe vaso-occlusive events (VOEs) through up to 36 months of follow-up in 25 patients who had a history of at least four severe VOEs and at least six months follow-up in Group C of its ongoing Phase 1/2 HGB-206 study of lovo-cel for patients with SCD. The safety data presented remain consistent with the known side effects of autologous hematopoietic stem cell collection, myeloablative single-agent busulfan conditioning and underlying SCD. Select data from the Group C cohort of the HGB-206 study were simultaneously published in The New England Journal of Medicine (NEJM).

    BETI-CEL

    • BETI-CEL BLA ACCEPTANCE AND PRIORITY REVIEW - On November 22, 2021, bluebird bio announced that the FDA accepted for priority review its BLA for betibeglogene autotemcel (beti-cel), the Company's potentially curative gene therapy for adult, adolescent and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions. On January 18, 2022, the FDA extended the review period for the BLA and revised the Prescription Drug User Fee Act (PDUFA) goal date to August 19, 2022. Under priority review, bluebird would be eligible to receive a priority review voucher upon potential approval of beti-cel in 2022.
    • DATA AT ASH AND PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE - On December 11, 2021, at the 63rd ASH Annual Meeting, bluebird bio presented new data showing that adult and pediatric patients living with β-thalassemia who require regular RBC transfusions can produce normal or near-normal levels of total hemoglobin and continue to remain transfusion-free, and achieve stable iron markers, through up to seven years of follow-up in the ongoing long-term follow-up study (LTF-303) of beti-cel. In the safety data presented there were zero deaths or vector-derived replication-competent lentivirus, and no events of insertional oncogenesis or malignancy in LTF-303. The majority of AEs and SAEs were unrelated to beti-cel and consistent with the known side effects of HSC collection and busulfan conditioning regimen. Data from the pivotal HGB-207 Northstar-2 study were also simultaneously published in an original article in the NEJM.

    ELI-CEL

    • ELI-CEL CLINICAL HOLD - The Company remains in communication with the FDA regarding the clinical hold. The FDA has notified the Company that the clinical hold on the elivaldogene autotemcel (eli-cel) program will remain in place and requested additional information about safety events and monitoring in the eli-cel clinical program.
    • ELI-CEL BLA ACCEPTANCE AND PRIORITY REVIEW - On December 17, 2021, bluebird bio announced that the FDA accepted for priority review its BLA for eli-cel, the Company's gene therapy for cerebral adrenoleukodystrophy in patients less than 18 years of age. On January 18, 2022, the FDA extended the review period for the BLA and revised the PDUFA goal date to September 16, 2022. Under priority review, bluebird would be eligible to receive a priority review voucher upon potential approval of eli-cel in 2022.

    COMPANY

    • NEW BOARD OF DIRECTORS APPOINTMENT – Today, bluebird bio announced the appointment of Charlotte Jones-Burton, M.D., M.S., to its Board of Directors. Dr. Jones-Burton is Senior Vice President, Product Development and Strategy at Chinook Therapeutics, a clinical-stage biotechnology company discovering, developing and commercializing precision medicines for rare, severe chronic kidney diseases. With more than 20 years of experience as a clinical development leader, internal medicine and nephrology physician and academician, Dr. Jones-Burton is dedicated to creating healthier communities through drug development, patient advocacy and people engagement. Dr. Jones-Burton earned a medical degree and Master of Science degree in Epidemiology and Preventive Medicine, with a concentration in Clinical Research, from the University of Maryland School of Medicine. Her postgraduate training included an internal medicine residency and a nephrology fellowship at the University of Maryland Medical Systems.

    UPCOMING ANTICIPATED MILESTONES

    LOVO-CEL

    • The Company is in active communication with the FDA to resolve the partial clinical hold and resume treating patients under the age of 18.
    • The Company plans to complete manufacturing of commercial drug product validation lots by mid-2022.
    • The Company expects to confirm vector and drug product analytical comparability by Q4 2022.
    • The Company is on track to submit its BLA for lovo-cel in Q1 2023.

    BETI-CEL

    • The FDA has set a PDUFA goal date of August 19, 2022, for a decision on the approval of beti-cel in patients with β-thalassemia with commercial launch expected to follow in mid-2022 if approved.
    • bluebird bio anticipates an FDA advisory committee meeting for beti-cel and eli-cel will be held over the course of two days on June 9-10, 2022.

    ELI-CEL

    • The FDA has set a PDUFA goal date of September 16, 2022, for a decision on the approval of eli-cel in patients with cerebral adrenoleukodystrophy with commercial launch expected to follow by the end of 2022 if approved.
    • bluebird bio anticipates an FDA advisory committee meeting for beti-cel and eli-cel will be held over the course of two days on June 9-10, 2022.

    FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

    • Cash Position: The Company's restricted cash, cash and cash equivalents and marketable securities balance was approximately $442 million, including restricted cash of approximately $46 million, as of December 31, 2021. The full-year 2022 cash burn is expected to be less than $400 million. The Company's expectation to generate operating losses and negative operating cash flows in the future and the need for additional funding to support its planned operations raise substantial doubt regarding its ability to continue as a going concern for a period of one year after the date that its consolidated financial statements for the year ended December 31, 2021 are issued.



      The Company is exploring multiple financing opportunities, including plans for the sale of priority review vouchers, which the Company would be eligible to receive upon potential approval of beti-cel and eli-cel in 2022, while focusing on further cost efficiencies.



    • Revenues: Total revenue from continuing operations was $1.6 million and $3.7 million for the three and twelve months ended December 31, 2021, respectively. The Company did not recognize revenue from continuing operations in 2020.



    • R&D Expenses: Research and development expenses from continuing operations were $79.4 million for the three months ended December 31, 2021, compared to $58.8 million for the three months ended December 31, 2020. Research and development expenses were $319.9 million for the twelve months ended December 31, 2021, compared to $319.3 million for the twelve months ended December 31, 2020.



    • SG&A Expenses: Selling, general and administrative expenses from continuing operations were $53.2 million for the three months ended December 31, 2021, compared to $80.6 million for the three months ended December 31, 2020. Selling, general and administrative expenses were $210.0 million for the twelve months ended December 31, 2021, compared to $240.0 million for the twelve months ended December 31, 2020.



    • Net Loss: Net loss from continuing operations was $132.3 million for the three months ended December 31, 2021, compared to $136.3 million for the three months ended December 31, 2020. Net loss from continuing operations was $562.6 million for the twelve months ended December 31, 2021, compared to $561.1 million for the twelve months ended December 31, 2020.

    About bluebird bio, Inc.

    bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days.

    With a dedicated focus on severe genetic diseases, bluebird has industry-leading clinical programs for sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy and is advancing research to apply new technologies to these and other diseases. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward.

    Founded in 2010, bluebird has the largest and deepest ex-vivo gene therapy data set in the world—setting the standard for the industry. Today, bluebird continues to forge new paths, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds.

    bluebird bio is a trademark of bluebird bio, Inc.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Company's financial condition, results of operations, as well as statements regarding the Company's plans and expectations for operations including expected timing relating to its manufacturing plans, regulatory approvals and commercial launches; the Company's plans and expectations for the timing of BLA submissions; the Company's plans to confirm vector and drug product analytical comparability; the timing of expected FDA advisory committee meetings; and the expectations for being granted any priority review voucher upon approval of any BLA . Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company may not be able to execute an orderly wind down of European operations with the timing or at a cost that we anticipated; the risk that additional insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation will be discovered or reported over time; the risk that the FDA may impose a clinical hold on additional programs utilizing lentiviral vectors; the risk that we may not address the FDA's concerns regarding eli-cel quickly or at all; the risk that the FDA may require additional information, testing, or monitoring that results in a delay to our regulatory submission plans including our BLAs for lovo-cel, beti-cel and eli-cel; the risks that we may not achieve the expected benefits of a separation, and a separation could harm our business, results of operations and financial condition; dedicated financial and/or strategic funding sources may not be available on favorable terms; the risk that we are unable to realize the intended benefits of resizing and reshaping our workforce; the COVID-19 pandemic and resulting economic conditions will have a greater impact on the Company's operations and plans than anticipated; that preliminary positive efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in our ongoing or future clinical trials; the risk that the current or planned clinical trials of our product candidates will be insufficient to support regulatory submissions or marketing approval in the United States; and the risk that any one or more of our product candidates, will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

     

    bluebird bio, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except per share data)

    (unaudited)

     

     

     

    For the three months ended

    December 31,

     

    For the twelve months ended

    December 31,

     

     

    2021

     

     

     

    2020

     

     

     

    2021

     

     

     

    2020

     

    Revenue:

     

     

     

     

     

     

     

    Product revenue

    $

    1,358

     

     

    $

    —

     

     

    $

    2,850

     

     

    $

    —

     

    Other revenue

     

    248

     

     

     

    —

     

     

     

    812

     

     

     

    —

     

    Total revenues

     

    1,606

     

     

     

    —

     

     

     

    3,662

     

     

     

    —

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

     

    79,384

     

     

     

    58,815

     

     

     

    319,946

     

     

     

    319,309

     

    Selling, general and administrative

     

    53,206

     

     

     

    80,572

     

     

     

    209,969

     

     

     

    239,950

     

    Cost of product revenue

     

    3,682

     

     

     

    —

     

     

     

    38,857

     

     

     

    —

     

    Restructuring expense

     

    1,001

     

     

     

    —

     

     

     

    25,801

     

     

     

    —

     

    Total operating expenses

     

    137,273

     

     

     

    139,387

     

     

     

    594,573

     

     

     

    559,259

     

    Loss from operations

     

    (135,667

    )

     

     

    (139,387

    )

     

     

    (590,911

    )

     

     

    (559,259

    )

    Interest income, net

     

    146

     

     

     

    641

     

     

     

    879

     

     

     

    5,770

     

    Other income (expense), net

     

    3,283

     

     

     

    2,678

     

     

     

    27,652

     

     

     

    (6,881

    )

    Loss before income taxes

     

    (132,238

    )

     

     

    (136,068

    )

     

     

    (562,380

    )

     

     

    (560,370

    )

    Income tax (expense) benefit

     

    (89

    )

     

     

    (253

    )

     

     

    (258

    )

     

     

    (686

    )

    Net loss from continuing operations

     

    (132,327

    )

     

     

    (136,321

    )

     

     

    (562,638

    )

     

     

    (561,056

    )

    Net loss from discontinued operations

     

    (22,725

    )

     

     

    (63,553

    )

     

     

    (256,740

    )

     

     

    (57,639

    )

    Net loss

    $

    (155,052

    )

     

    $

    (199,874

    )

     

    $

    (819,378

    )

     

    $

    (618,695

    )

    Net loss per share from continuing operations—basic and diluted

    $

    (1.83

    )

     

    $

    (2.05

    )

     

    $

    (8.16

    )

     

    $

    (9.02

    )

    Net loss per share from discontinued operations—basic and diluted

    $

    (0.31

    )

     

    $

    (0.96

    )

     

    $

    (3.73

    )

     

    $

    (0.93

    )

    Net loss per share—basic and diluted

    $

    (2.14

    )

     

    $

    (3.01

    )

     

    $

    (11.89

    )

     

    $

    (9.95

    )

    Weighted-average number of common shares used in computing net loss per

    share—basic and diluted

     

    72,498

     

     

     

    66,395

     

     

     

    68,190

     

     

     

    62,178

     

     

    bluebird bio, Inc.

    Condensed Consolidated Balance Sheet Data

    (in thousands, except per share data)

    (unaudited)

     

     

    As of

    December 31,

    2021

     

    As of

    December 31,

    2020

    Cash, cash equivalents and marketable securities

    $

    396,617

     

    $

    741,673

    Total assets

    $

    593,795

     

    $

    1,781,252

    Total liabilities

    $

    219,518

     

    $

    426,196

    Total stockholders' equity

    $

    374,277

     

    $

    1,355,056

     

    View source version on businesswire.com: https://www.businesswire.com/news/home/20220304005455/en/

    Get the next $BLUE alert in real time by email

    Chat with this insight

    Save time and jump to the most important pieces.

    Recent Analyst Ratings for
    $BLUE

    DatePrice TargetRatingAnalyst
    2/24/2025Underweight → Neutral
    Analyst
    2/24/2025$29.00Overweight
    Analyst
    11/18/2024Neutral → Underweight
    Analyst
    11/15/2024Neutral → Underweight
    JP Morgan
    11/15/2024$3.00 → $0.50Buy → Neutral
    BofA Securities
    8/15/2024Overweight → Neutral
    JP Morgan
    12/11/2023Hold → Reduce
    HSBC Securities
    12/8/2023$3.00 → $7.00Underweight → Equal-Weight
    Morgan Stanley
    More analyst ratings

    $BLUE
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • Important Information for bluebird bio Stockholders to Tender Shares for Acquisition by Carlyle and SK Capital

      bluebird bio, Inc. (NASDAQ:BLUE) ("bluebird") today reminds all stockholders, including individual stockholders, to promptly tender their shares into the tender offer by Carlyle and SK Capital to purchase all outstanding shares of bluebird common stock by 11:59 p.m. Eastern on May 12, 2025. Stockholders that hold shares of bluebird common stock through a broker or other nominee may be subject to a processing cutoff that is prior to the tender deadline, so it is important to act now. Every share tendered by stockholders is important and it is important to tender now. If a majority of the outstanding shares of bluebird common stock are not tendered, the tender offer will not be completed, a

      5/9/25 8:30:00 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Carlyle and SK Capital Receive All Required Regulatory Approvals to Complete the Acquisition of bluebird bio

      bluebird Board of Directors unanimously supports the transaction as the only viable option for stockholders to receive consideration for their shares and recommends that all stockholders immediately tender their shares into the offer Parties expect the merger to be completed promptly following the successful completion of the ongoing tender offer bluebird bio, Inc. (NASDAQ:BLUE) ("bluebird" or "the Company"), Carlyle (NASDAQ:CG) ("Carlyle"), SK Capital Partners, LP ("SK Capital") and Beacon Parent Holdings, L.P. ("Parent") announced today that all required regulatory approvals to complete the previously announced acquisition of the Company by Carlyle and SK Capital have been received. No

      5/5/25 4:00:00 PM ET
      $BLUE
      $CG
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
      Investment Managers
      Finance
    • bluebird bio confirms that Ayrmid, Ltd. has not delivered a binding offer or obtained necessary financing despite extensive engagement

      bluebird Board reaffirms unanimous recommendation in support of transaction with Carlyle and SK Capital and recommends all stockholders tender into the current agreement by May 2, 2025 bluebird bio, Inc. (NASDAQ:BLUE) ("bluebird" or "the Company") today announced that after three weeks of engagement, including a timeline extension, Ayrmid Ltd. ("Ayrmid") has not submitted a binding proposal to acquire bluebird and has not obtained necessary financing. In consultation with its financial and legal advisors, the bluebird Board of Directors (the "Board") reaffirms its recommendation in support of the transaction with Carlyle and SK Capital and recommends all stockholders tender into the curren

      4/16/25 8:00:00 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $BLUE
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • Chief Medical Officer Colvin Richard A sold $2,289 worth of shares (584 units at $3.92), decreasing direct ownership by 7% to 7,610 units (SEC Form 4)

      4 - bluebird bio, Inc. (0001293971) (Issuer)

      3/5/25 4:05:53 PM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Officer Klima Thomas J sold $1,960 worth of shares (500 units at $3.92), decreasing direct ownership by 6% to 7,878 units (SEC Form 4)

      4 - bluebird bio, Inc. (0001293971) (Issuer)

      3/5/25 4:05:41 PM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • President and CEO Obenshain Andrew sold $3,610 worth of shares (921 units at $3.92), decreasing direct ownership by 5% to 18,327 units (SEC Form 4)

      4 - bluebird bio, Inc. (0001293971) (Issuer)

      3/5/25 4:05:24 PM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $BLUE
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • Bluebirdbio upgraded by Analyst

      Analyst upgraded Bluebirdbio from Underweight to Neutral

      2/24/25 7:05:14 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Analyst initiated coverage on Bluebirdbio with a new price target

      Analyst initiated coverage of Bluebirdbio with a rating of Overweight and set a new price target of $29.00

      2/24/25 7:04:33 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Bluebirdbio downgraded by Analyst

      Analyst downgraded Bluebirdbio from Neutral to Underweight

      11/18/24 4:13:05 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $BLUE
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • Amendment: SEC Form SC 13G/A filed by bluebird bio Inc.

      SC 13G/A - bluebird bio, Inc. (0001293971) (Subject)

      11/14/24 4:39:36 PM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Amendment: SEC Form SC 13G/A filed by bluebird bio Inc.

      SC 13G/A - bluebird bio, Inc. (0001293971) (Subject)

      11/14/24 4:27:32 PM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Amendment: SEC Form SC 13G/A filed by bluebird bio Inc.

      SC 13G/A - bluebird bio, Inc. (0001293971) (Subject)

      11/14/24 10:32:08 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $BLUE
    Financials

    Live finance-specific insights

    See more
    • bluebird bio Reports Third Quarter 2024 Results and Highlights Operational Progress and 2024 Guidance

      - 74 patient starts completed or scheduled to date in 2024 across bluebird's commercial portfolio - - Third quarter 2024 net revenue of $10.6 million reflects quarter-to-quarter fluctuations in drug product infusions; anticipate at least $25 million of net revenue in the fourth quarter - - Management to host conference call today, November 14, 2024 at 8:00 am ET - bluebird bio, Inc. (NASDAQ:BLUE) ("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. "Patient starts more than doubled from our second to third quarter update, providing clear evidence

      11/14/24 7:00:00 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • bluebird bio Adjourns Meeting of Stockholders and Announces Third Quarter Results Call

      bluebird bio, Inc. (NASDAQ:BLUE) ("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,

      11/6/24 4:15:00 PM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • bluebird bio Initiates Restructuring Intended to Optimize Cost Structure and Enable Quarterly Cash Flow Break-Even in the Second Half of 2025

      Actions intended to reduce cash operating expenses by approximately 20% Management team to host conference call today, September 24 at 8:00 am ET 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 tar

      9/24/24 7:00:00 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $BLUE
    FDA approvals

    Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

    See more
    • December 8, 2023 - FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

      For Immediate Release: December 08, 2023 Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signali

      12/8/23 11:12:21 AM ET
      $BLUE
      $VRTX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
      Biotechnology: Pharmaceutical Preparations
    • August 17, 2022 - FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions

      For Immediate Release: August 17, 2022 Today, the U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions.  “Today’s approval is an important advance in the treatment of beta-thalassemia, particularly in individuals who require ongoing

      8/17/22 2:12:27 PM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $BLUE
    SEC Filings

    See more
    • Amendment: SEC Form SC 14D9/A filed by bluebird bio Inc.

      SC 14D9/A - bluebird bio, Inc. (0001293971) (Subject)

      5/9/25 8:44:57 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Amendment: SEC Form SC 14D9/A filed by bluebird bio Inc.

      SC 14D9/A - bluebird bio, Inc. (0001293971) (Subject)

      5/6/25 7:47:43 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Amendment: SEC Form SC TO-T/A filed by bluebird bio Inc.

      SC TO-T/A - bluebird bio, Inc. (0001293971) (Subject)

      5/6/25 7:33:39 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $BLUE
    Leadership Updates

    Live Leadership Updates

    See more
    • 2Flo Ventures Announces Addition of Renowned Life Sciences Executive Charlotte Jones-Burton, MD, MS as a Partner

      CHICAGO, June 2, 2024 /PRNewswire/ -- 2Flo Ventures, an emerging venture capital firm and startup studio focused on the discovery, development, and commercialization of healthcare solutions that address disparities in outcomes and health equity broadly, is pleased to announce the addition of Dr. Charlotte Jones-Burton as a Partner and Head of Life Science Product Development and Strategy. 2Flo Ventures Announces Addition of Renowned Life Sciences Executive Charlotte Jones-Burton, MD, MS as a PartnerDr. Jones-Burton brings to 2Flo Ventures nearly two decades of experience in th

      6/2/24 10:15:00 PM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • bluebird bio Appoints O. James Sterling as Chief Financial Officer

      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 extensive experience in the healthcare sector and knowledge of the capital markets will position us well as we work to prove the commercial gene therapy model, and demonstrate progress on our path to profitability," said Andrew Obenshain, chief executive officer, bluebird bio. "It is an honor to be joining bluebird bi

      5/29/24 7:00:00 AM ET
      $BLUE
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Engine Capital Sends Letter to 2seventy's Board of Directors Outlining Steps to Maximize Shareholder Value

      Believes 2seventy Could Be Conservatively Worth ~$9 Per Share if the Company Exclusively Focuses on Its Most-Valuable Asset Abecma, Reduces Corporate Overhead and Makes Improvements to the Composition of the Management Team and Board Engine Capital LP, which owns approximately 3% of 2seventy bio, Inc.'s (NASDAQ:TSVT) ("2seventy" or the "Company") outstanding shares, today announced that it sent the below letter the Company's Board of Directors (the "Board"). *** December 6, 2023 2seventy bio, Inc. 60 Binney Street Cambridge, MA 02142 Attention: Board of Directors Dear Members of the Board: Engine Capital LP (together with its affiliates, "Engine" or "we"), is a meaningful shareh

      12/6/23 8:00:00 AM ET
      $BLUE
      $TSVT
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
      Biotechnology: Pharmaceutical Preparations