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Faron Pharmaceuticals Ltd on Monday outlined its plans to further progress its study of an investigational cancer immunotherapy, after receiving positive and ‘valuable’ feedback from the US Food & Drug Administration. The Turku, Finland-based clinical-stage biopharmaceutical company said the FDA provided the feedback on its proposed clinical development plan for formal approval of its wholly-owned therapy bexmarilimab. It was received as part of the recent Bexmab study’s end-of-phase 2 meeting with the FDA, in which the FDA advised Faron to focus on frontline development to enable the therapy’s use across the entire higher-risk myelodysplastic syndrome indication. The meeting was requested to provide Faron with guidance on the design of its planned phase 2/3 trial evaluating bexmarilimab in combination with azacitidine. The trial will now begin with a dose optimisation run-in period comparing different regiments with the placebo. Once the optimal dose has been determined, the trial will transition into the registration stage. Myelodysplastic syndrome is a type of blood cancer that can in some cases progress to acute myeloid leukaemia. ‘We are extremely encouraged by the collaborative and highly productive dialogue with the FDA, which provided a clear and actionable path for the clinical development of bexmarilimab in frontline HR-MDS, an area of profound unmet medical need, said Faron Chief Executive Officer Juho Jalkanen. ‘The agency’s guidance has endorsed a direct route towards accelerated approval using complete response + CR equivalent per International Working Group 2023 criteria as a co-primary endpoint with overall survival. ‘This is a significant step forward in our mission to provide a potentially transformative new treatment option to patients and represents a major regulatory de-risking milestone, as we are now only one study away from getting bexmarilimab approved for the benefit of HR MDS patients.’ Shares in Faron Pharmaceuticals were up 8.2% at 227.30 pence in London on Monday morning. The stock has risen 30% over the past year. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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