Redeye comments on Faron’s announcement that it has reached alignment with the FDA on the registrational pathway for bexmarilimab in frontline high-risk MDS. We view the agency’s endorsement of a registrational phase II/III trial design, including a dose optimisation run-in and use of the new IWG 2023 criteria as co-primary endpoints, as encouraging and a regulatory de-risking step. While the run-in may extend timelines and a novel endpoint framework could introduce some uncertainties, we believe the guidance provides Faron with a clear route to potential accelerated approval and strengthens the case for bexmarilimab’s best-in-class potential.
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