December 29, 2025
Finance

Genmab Sharpens Focus on Key Late-Stage Drugs, Ends Acasunlimab Development

Strategic realignment aims to concentrate resources on high-potential candidates including Epkinly, petosemtamab, and Rina-S

Trade Idea
Genmab A/S ADS
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Summary

Genmab A/S has announced it will cease further clinical development of its immuno-oncology candidate acasunlimab. This decision aligns with the company's strategic intent to direct resources towards its most promising late-stage therapies. Genmab will prioritize Epkinly (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S), which continue to progress through advanced trials. The change does not affect the company’s full-year 2025 financial outlook.

Key Points

Genmab discontinues further clinical development of acasunlimab after strategic review.
Focus shifts to advancing late-stage candidates Epkinly (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S).
Decision aligns with comprehensive assessment of competitive environment and pipeline prioritization.
Acquisition of full development and commercialization rights for acasunlimab from BioNTech completed in August 2024, with BioNTech opting out.
Genmab A/S (NASDAQ: GMAB) revealed on Monday that it has decided to discontinue all ongoing clinical trials involving acasunlimab. This move was made following a comprehensive evaluation of the competitive landscape and represents part of Genmab’s broader strategy to allocate efforts and capital towards the most promising late-stage pipeline therapies that offer the highest potential value. While the data collected from acasunlimab’s clinical investigations have demonstrated encouraging therapeutic effects to date, the company has opted to streamline its development focus by channeling resources into a trio of late-stage assets: Epkinly (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S). These assets are advancing through clinical trials indicative of strong therapeutic potential and strategic importance to Genmab's portfolio. Epkinly, also known by its generic name epcoritamab, recently marked a significant milestone by securing approval from the U.S. Food and Drug Administration for treating a form of relapsed or refractory blood cancer, reinforcing its status as one of Genmab’s flagship products. Alongside Epkinly, petosemtamab and Rina-S are progressing in various late-stage studies, underscoring Genmab's commitment to broadening its impact within oncology. The termination of acasunlimab development will not influence Genmab’s projected financial targets for the full year of 2025, maintaining stability in the company’s anticipated fiscal performance. Earlier in August 2024, Genmab took over sole responsibility for the development and potential commercialization of acasunlimab after BioNTech SE (NASDAQ: BNTX) withdrew from the collaboration on this program. Prior to this shift, acasunlimab had been evaluated in several clinical trials spanning multiple cancer types. Specifically, the drug was involved in a Phase 3 trial targeting non-small cell lung cancer (NSCLC), two Phase 2 studies focusing on melanoma and NSCLC, and an initial Phase 1 study examining safety and efficacy in various solid tumors, as reflected on Genmab’s official platform. According to an analyst note by William Blair released on the same day as Genmab’s announcement, acasunlimab was previously modeled to reach peak sales of approximately $300 million. This forecast suggests that acasunlimab’s contribution to Genmab’s long-term revenue prospects was considered modest relative to the company’s overall pipeline. Matt Phipps, also analyzing Genmab's prospects, highlighted that the company’s three leading drugs collectively represent an $8 billion peak sales opportunity. Given this substantial market potential, he reaffirmed an Outperform rating for Genmab’s stock. Following these developments, trading for Genmab shares experienced a decline, closing around $32.73 per share on Monday, according to data from Benzinga Pro at the time of publication. This represented an approximate 2.05% decrease on the day. In summary, Genmab’s decision to halt acasunlimab’s clinical development reflects a deliberate repositioning to optimize its late-stage drug pipeline and focus capital deployment on therapies with greater commercial promise. The strategy highlights the company’s prioritization of resources aimed at maximizing shareholder value amid a competitive oncology market.
Risks
  • Potential impact on Genmab’s clinical portfolio breadth following acasunlimab discontinuation.
  • Market response reflected in a share price decrease of approximately 2.05% following announcement.
  • Uncertainty surrounding the clinical and commercial success of remaining late-stage drugs despite promising outlook.
  • Dependence on regulatory approvals and clinical trial outcomes to realize forecasted peak sales.
Disclosure
This article is intended for informational purposes only and does not constitute investment advice. Readers should conduct their own due diligence before making investment decisions.
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