Hemostemix received formal support from the U.S. Food and Drug Administration for its basket protocol approach, the company announced. The FDA’s endorsement clears a regulatory hurdle for testing a single therapy across multiple indications under one protocol, allowing Hemostemix to accelerate parallel evaluation of candidate indications. Basket protocols let sponsors evaluate a therapy across different diseases that share a biological marker or mechanism; the FDA’s backing reduces procedural uncertainty for Hemostemix as it plans simultaneous cohorts and could speed data readouts across indications. Company interactions with the agency will now focus on protocol specifics and cohort entry criteria.
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