Genmab secured U.S. Food and Drug Administration approval for its bispecific antibody EPKINLY (epcoritamab‑bysp) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma. The approval, granted on November 18, 2025, is based on the Phase III EPCORE FL‑1 study, which enrolled 243 patients and reported an overall response rate of 89 % and a complete response rate of 74 % in the treatment arm. Progression‑free survival was not reached in the EPKINLY + R2 group, compared with 11.2 months in the control arm, and the safety profile matched the known profiles of the individual agents, with no new safety signals.
Genmab’s first bispecific antibody combination to receive FDA approval, the EPKINLY + R2 indication expands the drug’s label beyond its accelerated approval as a single agent. The approval positions EPKINLY as a first‑line second‑line therapy for follicular lymphoma, a disease with limited options after relapse, and signals a strategic shift from a royalty‑dependent model to a more integrated biotechnology business. By converting accelerated approval to full approval and adding a combination therapy, Genmab strengthens its commercial pipeline and enhances its competitive standing in the bispecific antibody market.
Genmab’s Q3 2025 earnings, released on November 6, 2025, underscored the commercial momentum behind the approval. Diluted earnings per share of $6.46 beat analyst expectations of $4.86 by $1.60, a 33 % lift driven by disciplined cost management and a favorable mix of recurring revenue. Total revenue of $1.02 billion exceeded estimates of $983.65 million by $36 million, a 4 % increase largely attributable to higher sales of core oncology products and the early impact of the new EPKINLY indication. Operating profit rose 52 % year‑over‑year, reflecting both revenue growth and margin expansion in high‑margin specialty segments.
Executive Vice President and Chief Development Officer Judith Klimovsky highlighted the approval’s significance: “The FDA approval of EPKINLY + R2 is an important advancement for patients with follicular lymphoma, enabling treatment at initial recurrence when more effective intervention is needed. This milestone also underscores EPKINLY’s potential as the core therapy for B‑cell malignancies, demonstrating benefit in combination and earlier disease, and building on its established single‑agent platform.” Klimovsky’s remarks emphasize Genmab’s focus on expanding the therapeutic reach of its bispecific platform and accelerating its transition to a product‑centric model.
Analysts updated their outlooks in response to the approval, citing the robust clinical data from EPCORE FL‑1 and the strategic value of a first‑in‑class bispecific combination. The approval was identified as the primary driver of the positive market reaction, reinforcing confidence in Genmab’s pipeline and its ability to capture a growing share of the follicular lymphoma market.
The FDA approval, coupled with strong Q3 earnings, positions Genmab to accelerate commercialization of EPKINLY and to invest in next‑generation bispecific candidates. The company’s focus on cost discipline, recurring revenue, and a high‑margin specialty portfolio suggests a sustainable growth trajectory, while the expanded indication provides a new revenue stream that could further strengthen Genmab’s transition to a fully integrated biotechnology company.
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