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COPENHAGEN - Genmab A/S (NASDAQ:GMAB) revealed Monday that Johnson & Johnson (J&J) will not pursue the option to license HexaBody-CD38 (GEN3014) for development and commercialization. Despite promising initial clinical data, Genmab has also decided against further development of the therapy. This decision comes after a comprehensive review of clinical data, market considerations, and portfolio prioritization.
HexaBody-CD38 had been evaluated in a clinical study against multiple myeloma, showing an overall response rate of 55% compared to 52% for J&J’s DARZALEX FASPRO®. However, with a relatively short follow-up period, secondary efficacy endpoints, including duration of response and overall survival, are not yet mature. Treatment emergent adverse events in the HexaBody-CD38 arm included neutropenia and infusion-related reactions, among others, with no new safety concerns in the DARZALEX arm. Deaths reported in the study were not related to the treatments.
Genmab’s CEO, Jan van de Winkel, Ph.D., expressed disappointment in J&J’s decision but affirmed the clinical potential of the HexaBody platform for future applications. He highlighted Genmab’s focus on its late-stage clinical pipeline, including EPKINLY® and two wholly owned assets, rinatabart sesutecan (Rina-S™) and acasunlimab, which are in Phase 3 development.
The company reassured investors that this development would not affect Genmab’s 2025 financial guidance. Genmab is set to host a conference call today to discuss the details of this event.
The 3014-01 trial, a Phase 1/2 study, was designed to evaluate the safety and preliminary efficacy of HexaBody-CD38 monotherapy in patients with relapsed or refractory multiple myeloma and other blood cancers. Further mature data from the study will be presented at a future medical conference.
Genmab, headquartered in Copenhagen, remains committed to its mission of improving patients’ lives through innovative antibody therapeutics. According to InvestingPro analysis, the company appears undervalued at current levels, with 12 additional exclusive insights available to subscribers. The information in this article is based on a press release statement from Genmab A/S. For detailed financial analysis and real-time updates on Genmab and other biotech companies, visit InvestingPro’s Most Undervalued stocks list.
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