Galapagos NV’s Strategic Pivot: CAR-T Milestones and SpinCo Separation Signal Growth Ahead

Galapagos NV (GLPG) is undergoing a transformative year in 2025, with two major initiatives reshaping its future: advancing its lead CAR-T therapy, GLPG5101, toward pivotal trials and executing a strategic separation into two entities—Galapagos (oncology cell therapy specialist) and SpinCo (innovative medicine acquirer). These moves aim to capitalize on the company’s pipeline strengths while unlocking shareholder value through targeted focus and financial flexibility.

CAR-T Therapies: Progress and Pivotal Potential

Galapagos’ cell therapy pipeline is anchored by GLPG5101, a CD19-targeted CAR-T therapy for hematologic malignancies. The drug has been designated as a lead indication for mantle cell lymphoma (MCL), a aggressive blood cancer with limited treatment options post-relapse. Key milestones in 2025 include:
- First U.S. dosing in the Phase 1/2 ATALANTA-1 trial, expanding enrollment beyond Europe.
- Topline data from the indolent NHL cohort in early 2025, followed by updated MCL results in late 2025.
- Pivotal development set to begin in 2026, with a target approval date of 2028 if trials meet endpoints.

The therapy’s decentralized manufacturing platform is a differentiator, enabling fresh CAR-T cells to be delivered within 7 days—a stark contrast to the weeks-long process of competitors. This rapid turnaround could significantly improve patient outcomes and competitive positioning.

Meanwhile, GLPG5301, a BCMA-targeted CAR-T for multiple myeloma, is in Phase 1/2 trials (PAPILIO-1). While not yet in pivotal planning for 2025, data from this study (expected in 2026) will guide its future path.

SpinCo Separation: A Dual-Track Strategy for Growth

Galapagos’ separation into two entities—Galapagos (focused on oncology cell therapy) and SpinCo (acquisition-driven innovation)—is a bold strategic move to maximize value. Here’s the breakdown:
- Galapagos: Retains its CAR-T pipeline, including GLPG5101 and GLPG5301, and its decentralized manufacturing network. Post-separation, it aims to advance at least one clinical candidate annually starting in 2026, with a $500M cash reserve to fund operations.
- SpinCo: Receives €2.45 billion in funding to acquire or partner on transformative assets in oncology, immunology, and virology. Led by veteran CEO Henry Gosebruch, SpinCo will prioritize high-potential proof-of-concept programs.

The separation also resolves ties to Gilead Sciences, with Galapagos regaining full global rights to its cell therapy pipeline, while SpinCo assumes the OLCA agreement. This reorganization aims to streamline decision-making and resource allocation.

Risks and Considerations

While the strategy is ambitious, risks remain:
1. Regulatory and Clinical Hurdles: GLPG5101’s success hinges on positive Phase 1/2 data and regulatory alignment. Delays could push timelines beyond 2028.
2. Manufacturing Scale-Up: The seven-day production model must prove scalable for commercial supply, requiring robust partnerships with facilities like Moffitt Cancer Center and Catalent.
3. Leadership Transitions: CEO Paul Stoffels’ departure by mid-2026 and CFO Thad Huston’s exit may pose short-term challenges.
4. Market Competition: CAR-T therapies face intense competition from giants like Novartis and Bristol-Myers Squibb, which already have FDA-approved products.

Conclusion: A High-Reward, High-Risk Play

Galapagos NV’s 2025 initiatives position it for long-term growth, but investors must weigh risks against upside potential. Key data points underscore its strategic footing:
- Financial Strength: €3.3 billion in cash as of Q1 2025, with post-separation annual burn capped at €225M.
- Pipeline Momentum: GLPG5101’s 2026 pivot and SpinCo’s funding provide dual pathways to value creation.
- Manufacturing Edge: The seven-day CAR-T production could redefine standards in the field.

If Galapagos executes on its plans, the company could emerge as a leader in next-generation cell therapies, with SpinCo adding synergistic innovation. However, execution risks—particularly in clinical trials and leadership transitions—demand close monitoring. For investors with a long-term horizon, Galapagos’ strategic pivot presents a compelling opportunity to capitalize on the rising tide of oncology innovation.

Final Note: Always consider diversification and consult with a financial advisor before making investment decisions.