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Genmab A/S (GMAB) Scores FDA Breakthrough for Rina-S

Thu, Sep 11, 2025, 10:14 AM 2 min read

In this article, we will be taking a look at the 11 Best Performing Biotech Stocks So Far in 2025. Genmab A/S stands fifth among them.

Genmab A/S (NASDAQ:GMAB) is strengthening its position as a global leader in antibody-based therapies with both commercial successes and late-stage clinical progress in 2025. The company currently markets therapies such as Tivdak for cervical cancer and Epkinly for lymphoma, while advancing a robust pipeline targeting high-need oncology indications.

A key milestone this year is the FDA’s Breakthrough Therapy Designation for rinatabart sesutecan (Rina-S), an investigational antibody-drug conjugate for recurrent or progressive endometrial cancer following platinum-based and PD-(L)1 therapies. The designation is expected to accelerate regulatory review and underscores Rina-S’s potential to transform treatment in a patient group with limited options.

At the same time, Genmab A/S (NASDAQ:GMAB)’s bispecific antibody epcoritamab is showing strong potential as an outpatient therapy for diffuse large B-cell lymphoma (DLBCL). Data from the EPCORE NHL-6 Phase 2 trial revealed that 92% of patients were able to receive their first full dose in an outpatient setting, signaling a shift toward more accessible cancer care. These developments have contributed to Genmab emerging among the best performing stocks in oncology.

Genmab A/S (GMAB) Scores FDA Breakthrough for Rina-S

Beyond clinical advances, Genmab A/S (NASDAQ:GMAB) is expanding the global reach of Tivdak and Epkinly while leveraging its KYSO antibody platform to broaden its pipeline.

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