Latest news with #bluebirdbio
Globe and Mail
07-07-2025
- Health
- Globe and Mail
Sickle Cell Disease Drugs Market 2034: Clinical Trials, Prevalence, EMA, PDMA, FDA Approvals, Medication, Statistics, NICE Approval.Revenue and Companies by DelveInsight
Sickle Cell Disease companies working in the treatment market are Cellectis, Sana Biotechnology, Global Blood Therapeutics, Inc., CSL Behring, Pfizer, Aruvant Sciences, Graphite Bio, Novartis, Agios Pharmaceuticals, Forma therapeutics, Vertex Pharmaceuticals, Global Blood Therapeutics, Inc., Alfasigma, Novo Nordisk, bluebird bio, ExCellThera, Gamida Cell, KM Biologics/Takeda, Editas Medicine, and others. Sickle Cell Disease Market Summary In 2023, the Sickle Cell Disease (SCD) market across the 6MM was valued at approximately USD 650 million, with the United States dominating at ~USD 603 million (92% share), followed by France and the UK. SCD is a hereditary blood disorder caused by mutations in the HBB gene, resulting in abnormal hemoglobin (HbS) that distorts red blood cells into a sickle shape. These rigid cells obstruct microvasculature, triggering vaso-occlusive crises, anemia, acute chest syndrome, stroke, organ damage, and heightened infection risk, severely impacting patient quality of life and survival. Historically, management relied on NSAIDs, transfusions, chelators, and supportive care, with hydroxyurea (DROXIA) being the primary disease-modifying agent for decades. Recent approvals of ENDARI (L-glutamine), ADAKVEO (crizanlizumab), and OXBRYTA (voxelotor) have expanded options, though challenges in adherence and reimbursement persist. New approvals like CASGEVY (exa-cel) and LYFGENIA (lovo-cel) are expected to drive market growth, alongside pipeline candidates such as EDIT-301, Mitapivat, Inclacumab, and Osivelotor. Despite advances, delays in diagnosis, economic burden, and complications continue to constrain outcomes. Multidisciplinary care, genetic counseling, early intervention, and patient education are critical, while gene therapy and gene editing hold promise for transformative treatment, aiming to mitigate SCD's substantial clinical and economic impact in the coming decade. (Albany, USA) DelveInsight's ' Sickle Cell Disease Market Insights, Epidemiology, and Market Forecast-2034 ' report delivers an in-depth understanding of Sickle Cell Disease, historical and forecasted epidemiology as well as the Sickle Cell Disease market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. The Sickle Cell Disease market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Sickle Cell Disease market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Sickle Cell Disease treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Sickle Cell Disease market. Some facts of the Sickle Cell Disease Market Report are: According to DelveInsight, Sickle Cell Disease market size is expected to grow at a decent CAGR by 2034. Leading Sickle Cell Disease companies working in the market are Cellectis, Sana Biotechnology, Global Blood Therapeutics, Inc., CSL Behring, Pfizer, Aruvant Sciences, Graphite Bio, Novartis, Agios Pharmaceuticals, Forma therapeutics, Vertex Pharmaceuticals, Global Blood Therapeutics, Inc., Alfasigma, Novo Nordisk, bluebird bio, ExCellThera, Gamida Cell, KM Biologics/Takeda, Editas Medicine, and others. Key Sickle Cell Disease Therapies expected to launch in the market are BPX-501 T cells, Canakinumab, EPI01, CTX001, ADAKVEO, DROXIA, ENDARI, OXBRYTA, and many others. In May 2025, Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company specializing in precision genetic medicines via base editing, announced it will share new findings from its BEACON Phase 1/2 clinical trial of BEAM-101 at the upcoming European Hematology Association 2025 Congress (EHA2025), scheduled for June 12–15, 2025, in Milan, Italy. BEAM-101 is an investigational ex vivo genetically modified cell therapy being developed to treat sickle cell disease (SCD), specifically in patients experiencing severe vaso-occlusive crises (VOCs). In November 2024, BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial-stage biopharmaceutical company focused on oncology and rare diseases, announced that an abstract featuring initial results from a Phase 1 trial of motixafortide—both as a monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization in gene therapies for sickle cell disease (SCD)—has been accepted for oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, taking place December 7-10, 2024, in San Diego, California. Conducted in collaboration with Washington University School of Medicine in St. Louis, this proof-of-concept study aims to explore alternative HSC mobilization approaches to enhance the treatment experience for SCD patients undergoing gene therapy. In May 2024, Afimmune announced results of an Open-label Mechanistic Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Orally Administered Epeleuton in Patients With Sickle Cell Disease In April 2024, Pfizer announced results of an Open-label Extension Study to Evaluate the Long-term Safety of GBT021601 Administered to Participants With Sickle Cell Disease Who Have Participated in a GBT021601 Clinical Trial In April 2024, Novo Nordisk A/S (Forma Therapeutics, Inc.) announced results of an adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral Etavopivat, a Pyruvate Kinase Activator in Patients With Sickle Cell Disease (HIBISCUS). In July 2023, Novartis announced results of an Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study. Sickle Cell Disease Overview Sickle cell disease (SCD) is a hereditary blood disorder characterized by the production of abnormal hemoglobin, known as hemoglobin S. This defect causes red blood cells to assume a rigid, sickle-like shape, which impedes their ability to flow smoothly through blood vessels. Consequently, these misshapen cells can obstruct blood flow, leading to severe pain, organ damage, and an increased risk of infection. Sickle cell disease is most prevalent among individuals of African, Mediterranean, Middle Eastern, and Indian ancestry. Symptoms typically appear in early childhood and include episodes of pain (called sickle cell crises), chronic anemia, fatigue, swelling in the hands and feet, and delayed growth. Complications can be severe, including stroke, acute chest syndrome, and organ failure. Management of Sickle cell disease involves both preventive and therapeutic strategies. Preventive measures include regular vaccinations, antibiotics to prevent infections, and hydroxyurea, a medication that reduces the frequency of pain crises and the need for blood transfusions. Pain management, blood transfusions, and bone marrow transplants are critical therapeutic options for managing acute and chronic complications. Recent advancements in gene therapy and CRISPR technology hold promise for more effective treatments and potential cures for Sickle cell disease. Ongoing research and clinical trials aim to improve the quality of life for patients and reduce the burden of this debilitating disease. Do you know what will be the Sickle Cell Disease market share in 7MM by 2034 @ Sickle Cell Disease Treatment Market Sickle Cell Disease Market The Sickle Cell Disease market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Sickle Cell Disease market trends by analyzing the impact of current Sickle Cell Disease therapies on the market and unmet needs, and drivers, barriers, and demand for better technology. This segment gives a thorough detail of the Sickle Cell Disease market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Sickle Cell Disease market data are presented with relevant tables and graphs to give a clear view of the market at first sight. According to DelveInsight, the Sickle Cell Disease market in 7MM is expected to witness a major change in the study period 2020-2034. Sickle Cell Disease Epidemiology The Sickle Cell Disease epidemiology section provides insights into the historical and current Sickle Cell Disease patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Sickle Cell Disease market report also provides the diagnosed patient pool, trends, and assumptions. Interested to know how the emerging diagnostic approaches will be contributing in increased Sickle Cell Disease diagnosed prevalence pool? Download report @ Sickle Cell Disease Market Dynamics and Trends Sickle Cell Disease Drugs Uptake This section focuses on the uptake rate of the potential Sickle Cell Disease drugs recently launched in the Sickle Cell Disease market or expected to be launched in 2020-2034. The analysis covers the Sickle Cell Disease market uptake by drugs, patient uptake by therapies, and sales of each drug. Sickle Cell Disease Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on Sickle Cell Disease market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions. Sickle Cell Disease Pipeline Development Activities The Sickle Cell Disease report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Sickle Cell Disease key players involved in developing targeted therapeutics. Download report to know which TOP 3 therapies will be capturing the largest Sickle Cell Disease market share by 2034? Click here @ Sickle Cell Disease Companies and Medication Sickle Cell Disease Therapeutics Assessment Major key companies are working proactively in the Sickle Cell Disease Therapeutics market to develop novel therapies which will drive the Sickle Cell Disease treatment markets in the upcoming years are Cellectis, Sana Biotechnology, Global Blood Therapeutics, Inc., CSL Behring, Pfizer, Aruvant Sciences, Graphite Bio, Novartis, Agios Pharmaceuticals, Forma therapeutics, Vertex Pharmaceuticals, Global Blood Therapeutics, Inc., Alfasigma, Novo Nordisk, bluebird bio, ExCellThera, Gamida Cell, KM Biologics/Takeda, Editas Medicine, and others. Do you know how market launches of New drugs will be impacting the Sickle Cell Disease market CAGR? Download sample report @ Sickle Cell Disease Therapies and Clinical Trials Sickle Cell Disease Report Key Insights 1. Sickle Cell Disease Patient Population 2. Sickle Cell Disease Market Size and Trends 3. Key Cross Competition in the Sickle Cell Disease Market 4. Sickle Cell Disease Market Dynamics (Key Drivers and Barriers) 5. Sickle Cell Disease Market Opportunities 6. Sickle Cell Disease Therapeutic Approaches 7. Sickle Cell Disease Pipeline Analysis 8. Sickle Cell Disease Current Treatment Practices/Algorithm 9. Impact of Emerging Therapies on the Sickle Cell Disease Market Table of Contents 1. Key Insights 2. Executive Summary 3. Sickle Cell Disease Competitive Intelligence Analysis 4. Sickle Cell Disease Market Overview at a Glance 5. Sickle Cell Disease Disease Background and Overview 6. Sickle Cell Disease Patient Journey 7. Sickle Cell Disease Epidemiology and Patient Population 8. Sickle Cell Disease Treatment Algorithm, Current Treatment, and Medical Practices 9. Sickle Cell Disease Unmet Needs 10. Key Endpoints of Sickle Cell Disease Treatment 11. Sickle Cell Disease Marketed Products 12. Sickle Cell Disease Emerging Therapies 13. Sickle Cell Disease Seven Major Market Analysis 14. Attribute Analysis 15. Sickle Cell Disease Market Outlook (7 major markets) 16. Sickle Cell Disease Access and Reimbursement Overview 17. KOL Views on the Sickle Cell Disease Market 18. Sickle Cell Disease Market Drivers 19. Sickle Cell Disease Market Barriers 20. Appendix 21. DelveInsight Capabilities 22. Disclaimer About DelveInsight DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:
Yahoo
31-05-2025
- Business
- Yahoo
bluebird bio, Inc. (BLUE) Nears Acquisition by Carlyle and SK Capital
Investment firms The Carlyle Group Inc. (NASDAQ:CG) and SK Capital Partners, together with Beacon Parent Holdings, L.P., have successfully completed the tender offer for bluebird bio, Inc. (NASDAQ:BLUE) to acquire all outstanding common stock. With a value of either $3.00 per share plus a contingent value right or $5.00 per share in cash, the transaction is set to be finalized through a merger on June 2, 2025. A medical researcher inspecting a petri-dish filled with bacteria in a laboratory setting. We have previously seen how bluebird bio, Inc. (NASDAQ:BLUE), a biotechnology company engaging in gene therapies for serious genetic diseases, was both out of time and out of money. Among the challenges faced by the company were financial burdens, a high debt-to-capital ratio of 0.82, and a low current ratio of 0.55. In February, the management reported a deal with Carlyle and SK Capital Partners for $3 in cash and a $6.84 contingent value. Soon after, the entities secured approvals from the EU, China, and Turkey, meeting all the regulatory requirements. Under the terms of the agreement, the transaction is anticipated to advance without a vote from the bluebird bio, Inc. (NASDAQ:BLUE) stockholders, complying with Delaware's General Corporation Law. By offering a choice to the shareholders through an amended buyout agreement, the company provides immediate cash to those who desire it instead of potential future payments. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure. None. Sign in to access your portfolio
Yahoo
14-05-2025
- Business
- Yahoo
Important Information for bluebird bio Stockholders to Tender Shares for Acquisition by Carlyle and SK Capital
SOMERVILLE, Mass., May 09, 2025--(BUSINESS WIRE)--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, and bluebird will not be acquired, putting bluebird at significant risk of defaulting on its loan agreements with Hercules Capital and being forced into bankruptcy or liquidation. It is extremely unlikely that stockholders would receive any consideration for their shares in bankruptcy or liquidation. Stockholders who need assistance tendering their shares of common stock of bluebird may contact the Information Agent, Innisfree M&A Incorporated, by calling toll-free at (877) 825-8793. About bluebird bio Founded in 2010, bluebird has been setting the standard for gene therapy for more than a decade—first as a scientific pioneer and now as a commercial leader. bluebird has an unrivaled track record in bringing the promise of gene therapy out of clinical studies and into the real-world setting, having secured FDA approvals for three therapies in under two years. Today, we are proving and scaling the commercial model for gene therapy and delivering innovative solutions for access to patients, providers, and payers. With a dedicated focus on severe genetic diseases, bluebird has the largest and deepest ex-vivo gene therapy data set in the field, with industry-leading programs for sickle cell disease, ß-thalassemia, and cerebral adrenoleukodystrophy. 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. bluebird continues to forge new paths as a standalone commercial gene therapy company, 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. ADDITIONAL INFORMATION AND WHERE TO FIND IT This communication is not an offer to buy nor a solicitation of an offer to sell any securities of bluebird. The solicitation and the offer to buy shares of bluebird's common stock is being made pursuant to a Tender Offer Statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials, that were filed by Beacon Parent Holdings, L.P. ("Parent") and Beacon Merger Sub, Inc. ("Merger Sub") with the SEC on March 7, 2025. In addition, bluebird has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer with the SEC on March 7, 2025. The tender offer materials and the Solicitation/Recommendation statement, as they may be amended from time to time, contain important information that should be read carefully when they become available and considered before any decision is made with respect to the tender offer. Investors will be able to obtain a free copy of these materials and other documents filed by Parent, Merger Sub and bluebird with the SEC at the website maintained by the SEC at Investors may also obtain, at no charge, copies of these materials and other documents by calling Innisfree M&A Incorporated, the information agent for the Offer, toll-free at (877) 825-8793 for stockholders or by calling collect at (212) 750-5833 for banks or brokers. INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THESE DOCUMENTS, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 OF BLUEBIRD AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER. Forward-Looking Statements The statements included in this communication that are not a description of historical facts are forward-looking statements. Words or phrases such as "believe," "may," "could," "will," "estimate," "continue," "anticipate," "intend," "seek," "plan," "expect," "should," "would" or similar expressions are intended to identify forward-looking statements. The forward-looking statements are based on bluebird's current beliefs and expectations and include, but are not limited to: statements regarding beliefs about the potential benefits of the transaction contemplated by the Agreement and Plan of Merger, dated as of February 21, 2025 (the "Merger Agreement"), by and among bluebird, Parent and Merger Sub; the planned completion and timing of the transaction contemplated by the Merger Agreement; statements regarding bluebird's future results of operations and financial position; bluebird's expectations with respect to the commercialization of its products, including without limitation, patient demand, the timing and amount of revenue recognition; and bluebird's ability to establish favorable coverage for its therapies. Risks and uncertainties that could cause results to differ from expectations include: uncertainties as to the timing and completion of the offer and the merger; uncertainties as to the percentage of bluebird stockholders tendering their shares in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the offer or the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable regulatory and/or governmental entities (or any conditions, limitations or restrictions placed on such approvals); risks relating to bluebird's liquidity during the pendency of the offer and the merger or in the event of a termination of the Merger Agreement; risks that the milestone related to the contingent value right is not achieved; the effects of disruption caused by the transaction making it more difficult to maintain relationships with employees, collaborators, vendors and other business partners; risks related to diverting management's attention from bluebird's ongoing business operations; the risk that stockholder litigation in connection with the transactions contemplated by the Merger Agreement may result in significant costs of defense, indemnification and liability; delays and challenges in bluebird's commercialization and manufacturing of its products, including challenges in manufacturing vector for ZYNTEGLO and SKYSONA to meet current demand; the internal and external costs required for bluebird's ongoing and planned activities, and the resulting impact on expense and use of cash, has been, and may in the future be, higher than expected, which has caused bluebird, and may in the future cause bluebird, to use cash more quickly than it expects or change or curtail some of its plans or both; substantial doubt exists regarding bluebird's ability to continue as a going concern; bluebird's expectations as to expenses, cash usage and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than bluebird's assumptions; the risk that additional funding may not be available on acceptable terms, or at all; risks related to bluebird's loan agreement, including the risk that operating restrictions could adversely affect bluebird's ability to conduct its business, the risk that bluebird will not achieve milestones required to access future tranches under the agreement, and the risk that bluebird will fail to comply with covenants under the agreement, including with respect to required cash and revenue levels, which could result in an event of default; the risk that the efficacy and safety results from bluebird's prior and ongoing clinical trials will not continue or be seen in the commercial context; the risk that the QTCs experience delays in their ability to enroll or treat patients; the risk that bluebird experiences delays in establishing operational readiness across its supply chain; the risk that there is not sufficient patient demand or payer reimbursement to support continued commercialization of bluebird's therapies; the risk of insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation, including the risk of hematologic malignancy; the risk that bluebird's products, including LYFGENIA, will not be successfully commercialized; and other risks and uncertainties pertaining to bluebird's business, including the risks and uncertainties detailed in bluebird's prior filings with the SEC, including under the heading "Risk Factors" in bluebird's Annual Report on Form 10-K for the year ended December 31, 2024, and any subsequent Quarterly Reports on Form 10-Q filed with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update these statements to reflect events or circumstances after the date hereof, except as required by law. View source version on Contacts Investors:Courtney O'Leary978-621-7347coleary@ Media:Jess Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
09-05-2025
- Business
- Business Wire
Important Information for bluebird bio Stockholders to Tender Shares for Acquisition by Carlyle and SK Capital
SOMERVILLE, Mass.--(BUSINESS WIRE)--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, and bluebird will not be acquired, putting bluebird at significant risk of defaulting on its loan agreements with Hercules Capital and being forced into bankruptcy or liquidation. It is extremely unlikely that stockholders would receive any consideration for their shares in bankruptcy or liquidation. Stockholders who need assistance tendering their shares of common stock of bluebird may contact the Information Agent, Innisfree M&A Incorporated, by calling toll-free at (877) 825-8793. About bluebird bio Founded in 2010, bluebird has been setting the standard for gene therapy for more than a decade—first as a scientific pioneer and now as a commercial leader. bluebird has an unrivaled track record in bringing the promise of gene therapy out of clinical studies and into the real-world setting, having secured FDA approvals for three therapies in under two years. Today, we are proving and scaling the commercial model for gene therapy and delivering innovative solutions for access to patients, providers, and payers. With a dedicated focus on severe genetic diseases, bluebird has the largest and deepest ex-vivo gene therapy data set in the field, with industry-leading programs for sickle cell disease, ß-thalassemia, and cerebral adrenoleukodystrophy. 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. bluebird continues to forge new paths as a standalone commercial gene therapy company, 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. ADDITIONAL INFORMATION AND WHERE TO FIND IT This communication is not an offer to buy nor a solicitation of an offer to sell any securities of bluebird. The solicitation and the offer to buy shares of bluebird's common stock is being made pursuant to a Tender Offer Statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials, that were filed by Beacon Parent Holdings, L.P. ('Parent') and Beacon Merger Sub, Inc. ('Merger Sub') with the SEC on March 7, 2025. In addition, bluebird has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer with the SEC on March 7, 2025. The tender offer materials and the Solicitation/Recommendation statement, as they may be amended from time to time, contain important information that should be read carefully when they become available and considered before any decision is made with respect to the tender offer. Investors will be able to obtain a free copy of these materials and other documents filed by Parent, Merger Sub and bluebird with the SEC at the website maintained by the SEC at Investors may also obtain, at no charge, copies of these materials and other documents by calling Innisfree M&A Incorporated, the information agent for the Offer, toll-free at (877) 825-8793 for stockholders or by calling collect at (212) 750-5833 for banks or brokers. INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THESE DOCUMENTS, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 OF BLUEBIRD AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER. Forward-Looking Statements The statements included in this communication that are not a description of historical facts are forward-looking statements. Words or phrases such as 'believe,' 'may,' 'could,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'seek,' 'plan,' 'expect,' 'should,' 'would' or similar expressions are intended to identify forward-looking statements. The forward-looking statements are based on bluebird's current beliefs and expectations and include, but are not limited to: statements regarding beliefs about the potential benefits of the transaction contemplated by the Agreement and Plan of Merger, dated as of February 21, 2025 (the 'Merger Agreement'), by and among bluebird, Parent and Merger Sub; the planned completion and timing of the transaction contemplated by the Merger Agreement; statements regarding bluebird's future results of operations and financial position; bluebird's expectations with respect to the commercialization of its products, including without limitation, patient demand, the timing and amount of revenue recognition; and bluebird's ability to establish favorable coverage for its therapies. Risks and uncertainties that could cause results to differ from expectations include: uncertainties as to the timing and completion of the offer and the merger; uncertainties as to the percentage of bluebird stockholders tendering their shares in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the offer or the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable regulatory and/or governmental entities (or any conditions, limitations or restrictions placed on such approvals); risks relating to bluebird's liquidity during the pendency of the offer and the merger or in the event of a termination of the Merger Agreement; risks that the milestone related to the contingent value right is not achieved; the effects of disruption caused by the transaction making it more difficult to maintain relationships with employees, collaborators, vendors and other business partners; risks related to diverting management's attention from bluebird's ongoing business operations; the risk that stockholder litigation in connection with the transactions contemplated by the Merger Agreement may result in significant costs of defense, indemnification and liability; delays and challenges in bluebird's commercialization and manufacturing of its products, including challenges in manufacturing vector for ZYNTEGLO and SKYSONA to meet current demand; the internal and external costs required for bluebird's ongoing and planned activities, and the resulting impact on expense and use of cash, has been, and may in the future be, higher than expected, which has caused bluebird, and may in the future cause bluebird, to use cash more quickly than it expects or change or curtail some of its plans or both; substantial doubt exists regarding bluebird's ability to continue as a going concern; bluebird's expectations as to expenses, cash usage and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than bluebird's assumptions; the risk that additional funding may not be available on acceptable terms, or at all; risks related to bluebird's loan agreement, including the risk that operating restrictions could adversely affect bluebird's ability to conduct its business, the risk that bluebird will not achieve milestones required to access future tranches under the agreement, and the risk that bluebird will fail to comply with covenants under the agreement, including with respect to required cash and revenue levels, which could result in an event of default; the risk that the efficacy and safety results from bluebird's prior and ongoing clinical trials will not continue or be seen in the commercial context; the risk that the QTCs experience delays in their ability to enroll or treat patients; the risk that bluebird experiences delays in establishing operational readiness across its supply chain; the risk that there is not sufficient patient demand or payer reimbursement to support continued commercialization of bluebird's therapies; the risk of insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation, including the risk of hematologic malignancy; the risk that bluebird's products, including LYFGENIA, will not be successfully commercialized; and other risks and uncertainties pertaining to bluebird's business, including the risks and uncertainties detailed in bluebird's prior filings with the SEC, including under the heading 'Risk Factors' in bluebird's Annual Report on Form 10-K for the year ended December 31, 2024, and any subsequent Quarterly Reports on Form 10-Q filed with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update these statements to reflect events or circumstances after the date hereof, except as required by law.
Reuters
29-03-2025
- Business
- Reuters
Bluebird bio receives non-binding bid for up to $110.5 million
March 28 (Reuters) - Gene therapy maker bluebird bio (BLUE.O), opens new tab said on Friday it had received a non-binding offer from peer Ayrmid for up to $110.5 million, sending its shares up 9.8% at $4.40 in extended trading. Bluebird bio, which has been facing a cash crunch, first raised going-concern doubts three years ago. It laid off a quarter of its workforce last year to focus on launching three gene therapies, including Lyfgenia for sickle cell disease, which has had slow uptake. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Ayrmid, the parent company of cell therapy developer Gamida Cell, offered to acquire bluebird for $4.50 per share upfront, totalling about $43.8 million, according to Reuters calculations using data compiled by LSEG. The privately held UK company also offered an additional $6.84 per share, representing about $66.6 million, contingent upon bluebird achieving certain sales milestones. In February, bluebird bio said it had agreed to be taken private by Carlyle Group (CG.O), opens new tab and SK Capital Partners, for $3 per share upfront along with the same $6.84 per share, contingent upon it achieving certain sales milestones. Bluebird said its board is reviewing the Ayrmid proposal in consultation with its legal and financial advisors, and the board has not changed its recommendation in support of the Carlyle and SK Capital Partners deal.
