Bexmarilimab to advance into registrational Ph 2/3 study in 1L HR-MDS after positive meeting with the FDA
“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 Dr. Juho Jalkanen, Chief Executive Officer of Faron. “The agency’s guidance has endorsed a direct route towards accelerated approval using Complete Response (CR) + CR equivalent (CReq) per International Working Group (IWG) 2023 criteria as a co-primary endpoint with Overall Survival (OS). 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.”
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