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Genmab (GMAB) traded higher on Thursday after the Danish biotech, with its H1 2025 results, announced that its bispecific antibody epcoritamab, developed with AbbVie (ABBV) succeeded in a Phase 3 trial as a combination therapy for certain patients with follicular lymphoma.
Citing interim data, Genmab (GMAB) said that subcutaneous epcoritamab, with FDA-approved blood cancer therapies rituximab and lenalidomide (R2), reached the dual primary endpoints of overall response rate and progression-free survival in its Phase 3 EPCORE FL-1 trial.
Rituximab is marketed by Biogen and Roche (OTCQX:RHHBY) as Rituxan for conditions including non-Hodgkin’s lymphoma, and lenalidomide is marketed by Bristol Myers (BMY) as Revlimid for multiple myeloma and after stem cell transplant.
EPCORE FL-1, designed to evaluate the combo regimen versus R2 in relapsed/refractory follicular lymphoma, succeeded, as results for both endpoints were statistically significant and clinically meaningful, GMAB said.
The experimental therapy indicated a tolerability profile in line with the known safety profiles of the individual drugs. The U.S. FDA has already granted accelerated approval for epcoritamab as a monotherapy for R/R FL after two or more prior lines with systemic therapy.
Genmab (GMAB) added that on July 24, the agency accepted the company’s marketing application, which seeks a label expansion for the drug with R2 after at least one prior systemic therapy. The FDA has issued November 30, 2025, as the target action date in connection with the supplemental Biologics License Application.
As for H1 financials, GMAB reported $1.6M of revenue with ~19% YoY growth thanks to higher royalty income received from J&J (JNJ) and Novartis (NVS) related to its multiple myeloma therapy Darzalex and multiple sclerosis therapy Kesimpta, respectively.
The company also lifted its revenue outlook to $3.50B – $3.60B from $3.34B – $3.66B, indicating a $100M increase at the midpoint, compared to $3.6B in the consensus.
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