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Galapagos NV (GLPG)’ CAR-T Therapy Hits 97% Response Rate in Lymphoma Trial
Yahoo Finance· 2025-09-11 15:18
In this article, we will be taking a look at the 11 Best Performing Biotech Stocks So Far in 2025. Galapagos NV is one of them. Galapagos NV (NASDAQ:GLPG) is a Belgian-based firm and is carving out a leading position in next-generation oncology through its CAR-T programs and decentralized manufacturing model, designed to deliver faster, more accessible treatments for patients with hematological cancers. It is among the best performing stocks.  Galapagos NV (NASDAQ:GLPG)’s momentum centers on GLPG5101, a ...
11 Best Performing Biotech Stocks So Far in 2025
Insider Monkey· 2025-09-10 10:05
In this article, we will be taking a look at the 11 Best Performing Biotech Stocks So Far in 2025.On July 8, Jared Holz of Mizuho spoke on CNBC’s “Closing Bell Overtime” about whether the biotech sector is ready for a breakthrough. According to Jared Holz, the biotech sector has proven especially difficult to predict due in large part to the vast number of publicly traded stocks that, when combined, don’t show a clear, consistent trend with many positive and negative features. He noted that this is the reas ...
Galapagos NV Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to GLPG5101 for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
GlobeNewswire· 2025-08-06 05:30
Core Points - The U.S. FDA has granted RMAT designation to GLPG5101, a second generation anti-CD19/4-1BB CAR-T product candidate for relapsed/refractory mantle cell lymphoma [1][2] - RMAT designation aims to accelerate the development and review of promising cell and gene therapies for serious conditions, with GLPG5101 showing preliminary clinical evidence of potential effectiveness [2][3] - Clinical data from the ATALANTA-1 study supports the RMAT designation, demonstrating high objective and complete response rates with a manageable safety profile [3][4] Company Overview - Galapagos is a biotechnology company focused on transforming patient outcomes through innovative science and technology, with operations in Europe, the U.S., and Asia [9] - The company is dedicated to addressing high unmet medical needs and has developed a decentralized cell therapy manufacturing platform to enhance patient experience and treatment delivery [8][9] Study Details - The ATALANTA-1 study is evaluating the safety and efficacy of GLPG5101 in patients with various hematological malignancies, with a primary objective to assess safety and determine recommended dosing [6] - The study includes multiple dose levels and aims to evaluate the Objective Response Rate (ORR) and other secondary endpoints, with patients being followed for 24 months [6] RMAT Designation Benefits - The RMAT designation allows for increased FDA guidance, more frequent interactions, eligibility for accelerated approval, and early discussions on study endpoints, facilitating faster development timelines [4]
Galapagos(GLPG) - 2025 Q2 - Quarterly Report
2025-07-24 10:45
Exhibit 99.2 ABOUT THIS REPORT About This Report This report contains information required under Belgian law. Galapagos NV is a limited liability company organized under the laws of Belgium, having its registered office at Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium and registered with the Crossroads Enterprise Database (RPR Antwerp – division Mechelen) under number 0466.460.429. Throughout this report, the term "Galapagos NV" refers solely to the non-consolidated Belgian company, and references to ...
Galapagos Bolster Leadership Team with Seasoned Life Sciences Executives to Accelerate Business Transformation
Globenewswire· 2025-07-23 20:03
Appoints Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer Both executives possess proven track records in strategic execution and deal-making and will help drive long-term value creation at Galapagos Mechelen, Belgium; July 23, 2025, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced the appointments of Ms. Sooin Kwon as Chief Business Officer (CBO) and Mr. Dan Grossman as Chief Strategy Officer (CStO), effective August 4, 2025, further strengthening the Company ...
Galapagos Welcomes Seasoned Pharmaceutical Executives Dawn Svoronos and Jane Griffiths to Its Board of Directors
GlobeNewswire News Room· 2025-07-23 20:02
Core Insights - Galapagos NV has appointed Dawn Svoronos and Jane Griffiths as Non-Executive Independent Directors, effective July 28, 2025, replacing Peter Guenter and Simon Sturge [1][2] - The appointments are aimed at strengthening the Board and enhancing long-term value creation, with both new directors bringing extensive experience in the biopharmaceutical sector [2] Company Overview - Galapagos is a biotechnology company focused on transforming patient outcomes through innovative science and technology, with operations in Europe, the U.S., and Asia [4] - The company aims to address high unmet medical needs and is committed to developing a pipeline of best-in-class medicines [4] New Directors' Background - Dawn Svoronos has over 30 years of experience in the biopharmaceutical industry, including significant roles at Merck, where she led operations across 30 European markets and was involved in post-merger integration [2][3] - Jane Griffiths has extensive international corporate leadership experience, having served as Global Head of Actelion Ltd and held senior roles at Johnson & Johnson, focusing on corporate governance and sustainability initiatives [3]
Galapagos Reports Half-Year 2025 Financial Results and Provides Second Quarter Business Update
GlobeNewswire News Room· 2025-07-23 20:01
Core Insights - The company has appointed a new CEO, CFO, and experienced business development leaders to enhance shareholder value and expand its pipeline [1][2] - Strategic alternatives for the cell therapy business, including a potential divestiture, are under evaluation, while CAR-T programs show positive clinical momentum [1][3] - The company reported a strong cash position of €3.1 billion as of June 30, 2025, providing a solid foundation for growth [1][2] Strategic and Corporate Update - The Board of Directors decided to re-evaluate the previously proposed separation of the company into two entities, focusing on maximizing shareholder value [3][10] - Galapagos Cell Therapeutics has been established as a standalone entity to consolidate all cell therapy activities [3] - Morgan Stanley is acting as a financial advisor for the strategic review process [3] Leadership Changes - Henry Gosebruch has been appointed as CEO, succeeding Dr. Paul Stoffels, and Aaron Cox as CFO, succeeding Thad Huston [3] - Additional leadership appointments include Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer, effective August 4, 2025 [3] Financial Performance - Total net revenues for the first half of 2025 were €140.3 million, unchanged from the same period in 2024 [6][13] - R&D expenses increased by 91% to €278.0 million, primarily due to higher personnel costs and costs related to cell therapy programs [6][13] - The company reported a net loss of €259.1 million for the first half of 2025, compared to a net profit of €99.2 million in the same period of 2024 [9][16] Cell Therapy Pipeline - Galapagos is advancing its cell therapy pipeline, with promising data for GLPG5101 (CD19 CAR-T) showing a 97% complete response rate in a cohort of patients with relapsed/refractory indolent non-Hodgkin lymphoma [8] - The company is also exploring partnership opportunities for GLPG3667, a small molecule TYK2 inhibitor currently in Phase 3-enabling studies [8] Financial Guidance - The company plans to provide an updated cash outlook for 2025 during its third-quarter results, following recent leadership changes and strategic evaluations [19]
Galapagos Appoints Aaron Cox as Chief Financial Officer
Globenewswire· 2025-06-23 05:30
Core Insights - Galapagos NV has appointed Mr. Aaron Cox as Chief Financial Officer, effective July 7, 2025, succeeding Mr. Thad Huston, who will assist in the transition until July 31, 2025 [1][2] Group 1: Leadership Transition - Aaron Cox brings over 20 years of experience in biotechnology, capital markets, and M&A, having previously served as CFO at Horizon Therapeutics, where he was instrumental in the company's $28 billion acquisition by Amgen [2] - Cox's role at Galapagos will involve leading Finance, Accounting, Tax, Procurement, Communications, and Investor Relations, and he will be part of the Executive Committee [3] Group 2: Strategic Goals - The CEO of Galapagos expressed confidence in Cox's ability to accelerate pipeline growth through business development and disciplined financial management, aiming to create a new pipeline of innovative medicines [3] - Cox emphasized his excitement to join Galapagos at a pivotal moment, focusing on creating shareholder value and advancing innovations for patients [4] Group 3: Company Overview - Galapagos is a biotechnology company dedicated to transforming patient outcomes through innovative science, with a focus on high unmet medical needs and a commitment to delivering results for patients and shareholders [6]
Galapagos Presented New Data at ICML 2025 From Cohort 3 of ATALANTA-1 in Relapsed/Refractory Indolent NHL Patients, Demonstrating High Complete Response and MRD Negativity Rates With CAR-T Candidate GLPG5101
GlobeNewswire News Room· 2025-06-18 20:01
Core Insights - The ATALANTA-1 Phase 1/2 study of GLPG5101 shows promising efficacy and safety in treating relapsed/refractory indolent non-Hodgkin lymphoma, with a 97% complete response rate and 100% minimal residual disease negativity in evaluable patients [1][3][4] - The study highlights the advantages of a decentralized manufacturing platform, allowing for fresh CAR-T cell administration within seven days, which mitigates disease progression risks and spares patients from additional chemotherapy [2][5] Efficacy and Safety - In Cohort 3, 34 patients were enrolled, with 32 receiving GLPG5101; 94% received fresh CAR-T cells, and 93% were treated within seven days of manufacturing [1][3] - The complete response rate was 97%, with 31 out of 32 patients responding to treatment, and 100% of evaluable patients being MRD negative [3][4] - The 12-month progression-free survival rate was reported at 97%, with no relapses noted [3][4] Manufacturing and Administration - The decentralized manufacturing platform enables a median vein-to-vein time of seven days, allowing for timely treatment without the need for cytotoxic bridging therapy [2][5] - The final product showed a significant increase in early phenotype CD4+ and CD8+ CAR-T cells compared to the starting material [3] Study Design and Objectives - The ATALANTA-1 study is evaluating GLPG5101 in multiple hematological malignancies, focusing on safety, efficacy, and the feasibility of decentralized manufacturing [4] - The primary objective of the Phase 1 part is to assess safety and determine the recommended dose for Phase 2, while the Phase 2 part aims to evaluate the Objective Response Rate [4]
Galapagos to Present New ATALANTA-1 CAR-T Data at EHA 2025, Highlighting Low Toxicity and Rapid, Decentralized Delivery of Fresh, Early-Memory-Enriched GLPG5101 in R/R NHL
Globenewswire· 2025-06-12 20:01
Core Insights - The ongoing ATALANTA-1 Phase 1/2 study of Galapagos NV's investigational CD19 CAR T-cell therapy, GLPG5101, shows low rates of high-grade toxicities in heavily pretreated relapsed refractory non-Hodgkin's lymphoma patients [1][2] - The study highlights the effectiveness of a decentralized manufacturing platform that allows for rapid delivery of fresh CAR-T cells, significantly reducing patient attrition rates [2][8] Group 1: Study Overview - The ATALANTA-1 study includes 64 patients with various subtypes of relapsed refractory non-Hodgkin's lymphoma, demonstrating the feasibility of delivering fresh, stem-like early memory cell therapy with a median vein-to-vein time of seven days [3][5] - 95% of patients received fresh GLPG5101 without the need for cytotoxic bridging therapy, with 89% receiving treatment within 7 days post-leukapheresis [5][6] Group 2: Safety and Efficacy Data - The study reported a 5% attrition rate, significantly lower than the up to 30% rates seen in other clinical trials, indicating a manageable safety profile [2][5] - The majority of treatment-emergent adverse events were hematological, with low incidences of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [5][6] Group 3: Manufacturing and Delivery Innovations - Galapagos' decentralized manufacturing platform enables shorter vein-to-vein times and the use of fresh, early memory phenotype cells, potentially expanding CAR-T therapy access [2][8] - The platform utilizes an end-to-end workflow management system and automated manufacturing, enhancing patient experience and physician visibility [8][9] Group 4: Future Directions - The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe, with plans to amend the protocol to include chronic lymphocytic leukemia [7][12] - The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR), while secondary objectives include safety and feasibility assessments [7]