Precision Biosciences received FDA clearance of an Investigational New Drug enabling activation of a Phase I/II study (FUNCTION‑DMD) for PBGENE‑DMD, its genome‑editing candidate for ambulatory Duchenne muscular dystrophy. The company will activate the first U.S. study site in the first half of the year. The clearance permits initial human testing to evaluate safety and early efficacy signals in a high‑ unmet‑need rare disease. Precision framed PBGENE‑DMD as a next‑generation approach leveraging its proprietary gene‑editing platform to address DMD pathophysiology. The IND greenlight marks a key translational milestone for the platform and will be a near‑term inflection point for investors and clinicians tracking gene‑editing programs in neuromuscular disorders.
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