FNCH - Finch Therapeutics gains as FDA lifts clinical hold on antibacterial drug

The clinical-stage biotech Finch Therapeutics (NASDAQ:FNCH) announced that the U.S. Food and Drug Administration (FDA) lifted the clinical hold on its investigational new drug (IND) application for experimental antibacterial drug, CP101. Finch (FNCH) shares have surged ~37% in the pre-market Friday in reaction. An oral microbiome therapeutic, CP101, was undergoing late-stage trials for the prevention of recurrent C. difficile infection (CDI). The company expects to advance recruitments in its PRISM4 after completing certain steps, including several production processes and quality updates related to the resolved clinical hold. Finch (FNCH) also said that the company plans to submit a PRISM4 protocol amendment and a validation package to the FDA for its agreement. Details on the timing for the trial is expected with the company’s earnings release for 1Q 2022. Last week, Finch (FNCH) announced plans to reduce its workforce by ~20%, citing the need to save financial resources to advance CDI and autism spectrum disorder

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Finch Therapeutics gains as FDA lifts clinical hold on antibacterial drug