bluebird bio

bluebird bio, Inc. is a clinical-stage biotechnology company, which engages in the development of potential gene therapies for severe genetic diseases and cancer. Its integrated product platform includes gene therapy, cancer immunotherapy and gene editing. Its product pipeline includes Lenti-D, LentiGlobin, BCL11a shRNA, bb2121, and bb21217. The company was founded by Philippe Leboulch and Ronald C. Dorazio on April 16, 1992 and is headquartered in Somerville, MA.

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Bluebird bio reports strong financials and plans for expansion

Bluebird bio demonstrated financial strength and successful gene therapy launches.
Challenges include potential submission delay and operational complexities.
Opportunities lie in expanding patient demand, optimizing strategies, and exploring international markets.
Overall, Bluebird bio remains confident in its products and market positioning.

Bluebird bio excels in gene therapy market, faces manufacturing challenges

Bluebird bio is making significant strides in gene therapy, with successful commercial launches and a strong financial position.
Challenges lie in adapting to a different manufacturing process for lovo-cel and ensuring operational efficiency for future launches.
Opportunities abound in expanding commercial reach, leveraging expertise for targeted launches, and strategic decision-making on PRV monetization.

Bluebird bio reports revenue growth and milestones in Q3

Bluebird bio's Q3 performance showed revenue growth and positive momentum in key product launches.
The company faces challenges related to safety concerns, manufacturing issues, and analyst inquiries.
Strengths lie in a well-established commercial infrastructure and strategic pricing approach.
Opportunities include financing plans, potential voucher sale, and expansion of treatment centers.

bluebird bio reports revenue growth and eyes U.S. expansion opportunities

bluebird bio's Q4 performance showed revenue growth and extended cash runway
Strengths lie in commercial progress, multibillion-dollar U.S. opportunity, and margin improvement
Challenges include financial restatement, reimbursement dynamics, and Medicaid coverage
Opportunities exist in ex U.S. markets, expansion plans, and optimizing reimbursement strategies

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bluebird bio, Inc. is a clinical-stage biotechnology company, which engages in researching, developing and commercializing potentially transformative gene therapies for severe genetic diseases. It also offers ZYNTEGLO or beti-cel and SKYSONA or eli-cel gene therapies. The company was founded by Philippe Leboulch and Ronald C. Dorazio on April 16, 1992 and is headquartered in Somerville, MA.

The FDA placed a partial clinical hold on Bluebird's clinical studies of lovo-cel.

Why Bluebird Bio Stock Is Plunging Today

The FDA has placed a partial clinical hold on Bluebird bio Inc's (NASDAQ: BLUE) lovotibeglogene autotemcel (lovo-cel) gene therapy program for sickle cell disease (SCD) 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.

Why Are Bluebird Bio Shares Trading Lower Today?

Bluebird Bio Inc. BLUE, +13.34% said Monday the Food and Drug Administration has placed a partial clinical hold on patients below the age of 18 in its lovo-cel sickle cell gene therapy program. The temporary halt is due to an investigation by the company into an adolescent patient who has suffered persistent, non-transfusion-dependent anemia following treatment with lovo-cel, now 18 months after the treatment.

UPDATE: Bluebird Bio announces partial clinical hold for patients under 18 in sickle cell gene therapy program

Bluebird Bio announces partial clinical hold for patients under 18 in sickle cell gene therapy program

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (NASDAQ: BLUE) 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-treatmen

bluebird bio Announces Partial Clinical Hold for Patients Under 18 in Sickle Cell Gene Therapy Clinical Program

The FDA has accepted for priority review Buebird bio Inc's (NASDAQ: BLUE) marketing application for elivaldogene autotemcel (eli-cel, Lenti-D) for cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age.  The agency set a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2022.

Bluebird bio's Neurodegenerative Disease Gene Therapy Under Priority FDA Review, Despite Clinical Hold

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $BLUE--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 neurodegenerativ

bluebird bio Announces FDA Priority Review of Biologics License Application for eli-cel Gene Therapy for Cerebral Adrenoleukodystrophy (CALD) in Patients Without a Matched Sibling Donor

Bluebird (BLUE) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.

Bluebird (BLUE) Loses 20.9% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner

The stock price of bluebird bio Inc (NASDAQ: BLUE) increased by over 3% during intraday trading today. This is why it happened.

Bluebird Bio Stock (BLUE): Why The Price Increased Today

Bluebird bio Inc (NASDAQ: BLUE) 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. The updated data included further analyses from its pivotal cohort, HGB-206 Group C.

Bluebird Bio Posts Updated Data From Sickle Cell Gene Therapy Program

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $BLUE--bluebird bio, Inc. (NASDAQ: BLUE) 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 Grou

New and Updated Data Demonstrating Sustained Treatment Response in Patients Treated in Largest Sickle Cell Gene Therapy Program To-Date Presented at ASH21 and Published in NEJM

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $BLUE--bluebird bio, Inc. (Nasdaq: BLUE) today presented new results for betibeglogene autotemcel (beti-cel), a deeply studied investigational gene therapy, that demonstrate adult and pediatric patients living with β-thalassemia (beta-thal) who require regular red blood cell (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 (n

New Data at ASH21, Published in NEJM Further Demonstrate beti-cel as a Potentially Curative One-Time Gene Therapy for β-thalassemia Patients Who Require Regular Transfusions Through Achievement of Durable TI and Normal or Near-Normal Adult Hb Levels

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bluebird (BLUE) application seeking approval for beti-cel for thalassemia gets priority review in the United States.

bluebird (BLUE) Filing for Thalassemia Therapy Gets Priority Review

The FDA has accepted Bluebird bio Inc's (NASDAQ: BLUE) marketing application for betibeglogene autotemcel (beti-cel) for β-thalassemia. The agency has granted priority review for Beti-cel, gene therapy for β-thalassemia across all genotypes who require regular red blood cell transfusions.

Bluebird Bio's Thalassemia Gene Therapy Under Priority Review With FDA

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $BLUE--bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for betibeglogene autotemcel (beti-cel) for priority review. Beti-cel is a potentially transformative gene therapy for adult, adolescent and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions. If approved, beti-cel will be the first one-time treatmen

bluebird bio Announces FDA Priority Review of Biologics License Application for beti-cel Gene Therapy for Patients with β-thalassemia Who Require Regular Red Blood Cell Transfusions

Two analysts downgraded the biotech stock.

Why Bluebird Bio Stock Plunged Today

bluebird (BLUE) reports wider-than-expected loss for third-quarter 2021. It also misses revenue estimates.

bluebird (BLUE) Stock Down 19% on Q3 Earnings & Revenue Miss

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (NASDAQ: BLUE) today reported financial results and business highlights for the third quarter ended September 30, 2021. “This quarter was about preparing for the completion of the separation of bluebird bio and 2seventy bio and realizing the value of two independent companies," said Andrew Obenshain, chief executive officer, bluebird bio. "Notably this quarter, we secured additional capital through the close of a private financing and comple

bluebird bio Reports Third Quarter Financial Results and Recent Operational Progress

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $BLUE--bluebird bio, Inc. (NASDAQ: BLUE) announced today that it has signed a long-term lease with Federal Realty (Federal) to establish a biotech hub at Assembly Row. The 61,000 square foot facility to be located at 455 Grand Union Blvd. in Somerville is designed to meet the changing needs of bluebird bio's business, including its dedicated focus on gene therapies for severe genetic diseases following the recent spinoff of its oncology portfolio. The company expects

bluebird bio and Federal Realty to Establish Biotech Footprint at Assembly Row

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $BLUE--bluebird bio, Inc. (Nasdaq: BLUE) today announced that new data from its lentiviral vector (LVV) gene addition programs for patients with β-thalassemia (beta-thal) who require regular red blood cell (RBC) transfusions and sickle cell disease will be presented 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, Georgia, and virtually. bluebird bio wil

bluebird bio to Present New Gene Therapy Data at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $BLUE--bluebird bio, Inc. (NASDAQ: BLUE) today announced the company has completed the tax-free spin-off of its oncology programs and portfolio into 2seventy bio, Inc., an independent, publicly-traded company. bluebird bio will continue its work focused on severe genetic disease, with three near-term opportunities to bring transformative gene therapies to patients and their families in the U.S. 2seventy will begin regular-way trading on the NASDAQ under the stock tic

bluebird bio Completes Planned Business Separation

bluebird bio is preparing to spin off their cell therapy into a new publicly traded company, 2seventy bio. bluebird will focus on the company's gene therapy products. Although I am still fairly bullish on both tickers, I am concerned about where the market is going to take BLUE once the cell therapy pipeline has been removed.

bluebird bio: Waiting For The Dust To Settle

Bluebird Bio Inc (NASDAQ: BLUE) will withdraw the regulatory marketing authorization for Skysona (elivaldogene autotemcel) in the European Union. The update comes as a part of the company's winding down of operations there.

Bluebird Bio To Withdraw Marketing Of Skysona Gene Therapy In Europe

This gene-therapy specialist may need some help turning things around.

News for bluebird bio Stock (BLUE)