You’re on the fast track; FDA Fast Track status Precision BioSciences

Precision Biosciences (NASDAQ: DTIL) shares rose 13% Monday following the FDA’s Fast Track designation for PBGENE-DMD, its gene editing therapy for Duchenne muscular dystrophy.

The Fast Track designation aims to facilitate development and expedite review of the therapy, which is designed to treat the serious muscle-wasting condition. The designation allows for more efficient interactions with the FDA as development progresses.

“Fast Track designation is an important regulatory milestone for PBGENE-DMD and reflects the significant unmet need in DMD,” said Michael Amoroso, Chief Executive Officer of Precision BioSciences.

The company recently received IND clearance for PBGENE-DMD and plans to initiate a Phase 1/2 clinical study called FUNCTION-DMD. Precision BioSciences utilizes its proprietary ARCUS platform to develop in vivo gene editing therapies.

The Durham, North Carolina-based company announced it will host a virtual event on March 17, 2026, featuring Dr. Aravindhan Veerapandiyan, Pediatric Neurologist and Associate Professor of Pediatrics at Arkansas Children’s Hospital, and Pat Furlong, Founding President of Parent Project Muscular Dystrophy. The event will discuss the treatment landscape for Duchenne muscular dystrophy and provide an overview of the FUNCTION-DMD trial design.