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Galapagos NV (GLPG)’ CAR-T Therapy Hits 97% Response Rate in Lymphoma Trial
Yahoo Finance· 2025-09-11 15:18
Core Insights - Galapagos NV is recognized as one of the best performing biotech stocks in 2025, focusing on next-generation oncology through its CAR-T programs and decentralized manufacturing model [1] Group 1: Product Development and Clinical Trials - The momentum for Galapagos NV centers on GLPG5101, a CAR-T therapy for B-cell lymphomas, which recently received RMAT designation from the FDA for relapsed/refractory mantle cell lymphoma, showcasing promise in the ongoing Phase 1/2 ATALANTA-1 trial [2] - The company reported a 97% complete response rate and 100% MRD negativity in patients with indolent non-Hodgkin lymphoma at the 2025 ICML conference, with a vein-to-vein time of just seven days, distinguishing it from traditional CAR-T products [2][4] - Galapagos NV is expanding the ATALANTA-1 trial to new cohorts, including Richter transformation and chronic lymphocytic leukemia, while its second CAR-T candidate, GLPG5301, targeting multiple myeloma, is progressing through early development [3] Group 2: Manufacturing and Collaboration - A key differentiator for Galapagos NV is its decentralized manufacturing platform, enabling the production of "fresh" CAR-T therapies closer to patients, which enhances scalability and access [4] - Recent collaborations with the Moffitt Cancer Center in the U.S. and CELLforCURE in Paris are strengthening this decentralized manufacturing model [4]
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]