Genmab (GMAB) R&D Day 2025 summary

Pipeline overview and program updates

• Acquisition of Mirus and proposed acquisition of Merus accelerate the shift to a fully integrated, 100%-owned model, with integration targeted for early 2026.

• Accelerated late-stage pipeline development focuses on RINA-S, acasunlimab, petosemtamab, and Pathosentomab, with new data and trial initiations in 2025 and 2026.

• EPKINLY and TIVDAK expanded with new approvals and broader reach, including first independent launches in Japan and Europe, and infrastructure in place for future launches.

• Multiple potential registrational data sets for EPCORE, Rina-S, and beta centromere expected in 2026.

• Four KYSO products targeted for market in 2027, half fully owned.

Clinical trial data and development milestones

• EPCORE FL-1 phase III trial in relapsed follicular lymphoma showed 79% risk reduction in progression/death, 95% overall response rate, and 83% complete response rate with epcoritamab plus R-squared.

• Durable responses, preserved quality of life, and manageable safety profile observed, with no severe CRS and most infections mild and outpatient-managed.

• Frontline studies in follicular lymphoma and DLBCL demonstrated high response rates and sustained remissions at 2–3 years, supporting ongoing phase III trials.

• EPCORE DLBCL-2 phase III trial in newly diagnosed DLBCL to read out in 2026.

• ASH 2025 featured 31 acceptances, including 7 oral presentations, highlighting Epcoritamab's versatility and efficacy in B-cell lymphomas.

R&D strategy and innovation priorities

• Focus on maximizing late-stage assets and commercialized medicines, with targeted M&A, strategic investments, and capital allocation commitments.

• Emphasis on chemo-free, patient-friendly regimens, especially in follicular lymphoma, to challenge existing paradigms.

• Clear roadmap with additional phase III readouts and regulatory submissions planned for 2026.