Oral presentation of GLPG5101 data from the ATALANTA-1 study in patients with high-risk relapsed/refractory mantle cell lymphoma Two abstracts featuring new Phase 2 data highlight the potential of CAR-T cell therapy candidate, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma Results demonstrate high rates of complete and durable responses along with low rates of high-grade toxicities using GLPG5101 manufactured on innovative median seven-day vein-to-vein time platform, potentially enabling broader acc ...

New Directors bring strong financial leadership, capital allocation, and business development expertise to the Board Mechelen, Belgium; October 30, 2025, 21:01 CET — Galapagos NV (Euronext & NASDAQ: GLPG), today announced several changes to its Board of Directors as part of its ongoing commitment to long-term governance and strategic continuity. These changes strengthen the alignment of the Board’s composition with the Company’s strategic direction and support its focus on transformational business developm ...

Core Viewpoint - Galapagos NV is set to present new in vitro pharmacological data for its selective TYK2 inhibitor, GLPG3667, at the ACR Convergence 2025, highlighting its differentiation from other TYK2 inhibitors in clinical dose regimens [1][2]. Group 1: Study Overview - GLPG3667 is currently being evaluated in two Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM) [5]. - The GALACELA study is a randomized, double-blind, placebo-controlled trial assessing GLPG3667's efficacy and safety in adults with active SLE over 48 weeks [6]. - The GALARISSO study is also a randomized, double-blind, placebo-controlled trial focusing on GLPG3667's efficacy and safety in adults with DM over 24 weeks [9]. Group 2: Key Findings - At the clinical dose of 150 mg once daily, GLPG3667 demonstrated comparable inhibition of the IFN-α and IL-23 pathways to currently approved TYK2 inhibitors, with a more pronounced inhibition of the IL-12 pathway [7]. - GLPG3667 showed no measurable inhibition of IL-10-mediated signaling at concentrations significantly above clinical levels, unlike other TYK2 inhibitors [7]. - The primary endpoint for the GALACELA study is the proportion of patients achieving the SLE responder index (SRI)-4 response at Week 32, with secondary endpoints including various lupus assessment scores [6][8].

Core Insights - Galapagos NV is shutting down its cell and gene therapy (CGT) division after unsuccessful attempts to sell it, reflecting a broader trend of retreat in the biotech sector due to lost momentum and high costs [1][3] Company Summary - The Belgian biotech will close its CGT division, resulting in approximately 365 job losses across its operations in the Netherlands, Switzerland, the US, and China [2] - The restructuring is expected to incur operational costs of €100–€125 million ($115 million-145 million) and reconstruction costs of €150–€200 million by the end of 2026 [2] - Galapagos remains open to offers for a partial or full acquisition of the CGT unit during the wind-down period [3] Industry Summary - The CGT industry is experiencing a significant pullback in investment as companies face high manufacturing costs, scalability challenges, and uncertain commercial returns [3][6] - Recent examples of companies retreating from CGT include Novo Nordisk, which abandoned its R&D cell therapy division, and Takeda, which shifted focus back to small molecules and biologics [4] - Gilead Sciences' Kite Pharma also terminated a collaboration valued at over $2.3 billion for off-the-shelf cell therapies [5] - Despite challenges, the CGT market is projected to grow, with an estimated worth of around $79 billion by 2030 [7] - The industry calls for improved collaboration between regulators and companies, as well as the use of contract development and manufacturing organizations (CDMOs) to enhance development quality [8]

Core Viewpoint - Biotechnology firm Galapagos will cease its cell therapy business after unsuccessful attempts to sell it, resulting in the loss of 365 jobs across Europe, China, and the U.S. [1] Company Summary - Galapagos is winding down its cell therapy operations due to failed sale efforts [1] - The decision will impact 365 employees in multiple regions, including Europe, China, and the U.S. [1] Industry Summary - The biotechnology sector is facing challenges, as evidenced by Galapagos' decision to exit a segment of its business [1]

Core Viewpoint - Galapagos NV intends to wind down its cell therapy business to optimize capital allocation and focus on new transformational business development opportunities [1][3][11] Strategic Review and Decision - The decision follows a comprehensive strategic review that included exploring potential divestiture options, but no viable proposals were received [3][4] - The Board of Galapagos unanimously approved the wind down, with the exception of two Directors appointed by Gilead who recused themselves [4] Operational Impact - The wind down is expected to affect approximately 365 employees across Europe, the U.S., and China, and will involve the closure of sites in Leiden, Basel, Princeton, Pittsburgh, and Shanghai [5] - The remaining organization will focus on long-term growth through new business development while maintaining a presence in Mechelen, Belgium [5] Financial Implications - If the wind down proceeds, the company anticipates incurring operating costs of €100 million to €125 million from Q4 2025 through 2026, along with one-time restructuring costs of €150 million to €200 million in 2026 [6] - An updated cash outlook for 2025 will be provided with the company's third-quarter earnings report in early November [6] Future Focus - The company aims to enhance operational efficiencies and build a pipeline of novel therapeutics under the leadership of its new management team [2][3] - Galapagos will continue to consider any viable proposals for the cell therapy business during the wind down process [4]

Core Viewpoint - Galapagos NV has appointed Fred Blakeslee as Executive Vice President and General Counsel, effective October 16, 2025, succeeding Valeria Cnossen, who will leave the company after a transition period [1]. Group 1: Leadership Transition - Fred Blakeslee brings extensive legal expertise and global business transaction experience, particularly in the biopharma sector, which is expected to be valuable for Galapagos' transformation journey [1]. - The CEO, Henry Gosebruch, expressed gratitude towards Valeria Cnossen for her leadership and contributions over the past three years [1]. Group 2: Fred Blakeslee's Background - Blakeslee previously served as Vice President, Transactions, Legal at AbbVie, where he led legal teams in complex mergers and acquisitions, including AbbVie's $63 billion acquisition of Allergan PLC [1][2]. - He has a strong background in advising on private equity, corporate, and securities transactions, having started his career at Kirkland & Ellis LLP [2]. Group 3: 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 [3]. - The company aims to address high unmet medical needs and has a commitment to delivering results for patients, employees, and shareholders through a deep pipeline of best-in-class medicines [3].

Core Insights - Biotechnology firm Galapagos has received non-binding offers from consortia primarily made up of financial investors for its cell-therapy business [1] Company Summary - Galapagos' board is currently evaluating offers for its cell-therapy division, indicating potential strategic shifts or divestitures in its business model [1]

Core Viewpoint - Galapagos NV is exploring strategic alternatives for its cell therapy business, including a potential divestiture, to preserve shareholder value [1][3]. Group 1: Strategic Review Process - The Board of Directors has engaged with a wide range of strategic and financial parties to assess interest in acquiring the Cell Therapy Business [2]. - Interested parties have been granted access to a comprehensive data room and confidential presentations from Galapagos management [2]. - A limited number of non-binding offers have been received from consortia, mainly consisting of financial investors [3]. Group 2: Next Steps and Timeline - The Board and management are working with potential bidders to finalize due diligence and explore financing commitments [3]. - A decision on whether to continue with the divestment process or pursue other options is expected after receiving binding offers [4]. - An announcement regarding the outcome of the strategic alternatives review is anticipated by November 5, 2025, coinciding with the release of the third-quarter financial results [4]. Group 3: Company Overview - Galapagos is a biotechnology company focused on addressing high unmet medical needs through innovative science and technology [5]. - The company aims to transform patient outcomes and ensure that its innovations reach those who need them most [5].

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]