Genmab A/S, a biotechnology company listed on NASDAQ under the ticker GMAB, declared on Monday its decision to halt further clinical advancement of acasunlimab. This resolution emerges from a strategic reassessment prioritizing projects within its late-stage portfolio that promise the highest value creation for the company’s stakeholders.
According to Genmab, while the clinical data accumulated up to this point has demonstrated encouraging signs regarding acasunlimab's effectiveness and safety profile, the evolving dynamics of the competitive landscape have prompted a realignment of resources.
The firm intends to refocus its efforts primarily on three late-stage assets: Epkinly (epcoritamab), petosemtamab, and rinatabart sesutecan (referred to herein as Rina-S). These programs represent the cornerstone of Genmab’s development strategy moving forward, reflecting the company's commitment to maximizing potential impact and commercial opportunity.
Notably, the decision to discontinue development of acasunlimab will not affect Genmab's full-year financial guidance for 2025. This suggests confidence in the remaining portfolio's ability to meet or exceed previously forecasted performance metrics.
Earlier in August 2024, Genmab took over exclusive responsibility for acasunlimab's development and potential commercialization efforts. This change followed BioNTech SE's choice to withdraw from further participation in this particular program, transferring full ownership and associated risks to Genmab.
Clinical trials involving acasunlimab, as detailed on Genmab’s corporate website, included four ongoing studies: a Phase 3 trial targeting non-small cell lung cancer (NSCLC), two Phase 2 trials addressing melanoma and NSCLC respectively, and a Phase 1 trial investigating solid tumors more broadly. These studies represented varied efforts to evaluate acasunlimab's therapeutic profile across multiple oncological indications.
In terms of financial analysis, the equity research firm William Blair commented on Monday that their prior peak sales projections for acasunlimab were approximately $300 million. Consequently, it had been viewed as a relatively minor contributor to Genmab's overall peak revenue potential.
Analyst Matt Phipps highlighted that Genmab's three leading drug candidates possess combined peak sales opportunities estimated at around $8 billion. This considerable upside underpins his reaffirmation of an Outperform rating for the company’s shares, signaling optimistic market expectations about these core assets.
Following the announcement, Genmab’s stock price experienced a modest decline, trading down 2.05% to $32.73 at the time of reporting, based on data from Benzinga Pro. The market response reflects cautious investor sentiment balancing the pipeline adjustment against the projected growth from late-stage programs.