Precision BioSciences Inc. announced that it has received a Study May Proceed notification from the U.S. Food and Drug Administration (FDA) for its investigational gene editing therapy, PBGENE-DMD, intended for the treatment of ambulatory Duchenne muscular dystrophy (DMD) patients. This regulatory clearance enables the company to begin activating clinical trial sites and initiating Institutional Review Board (IRB) activities for the planned Phase 1/2 FUNCTION-DMD clinical study. The study aims to evaluate the safety, tolerability, and efficacy of PBGENE-DMD, including dystrophin protein expression and functional outcomes. Precision BioSciences plans to further discuss the program and study at a virtual investor event following the Muscular Dystrophy Association conference in March.

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