Precision BioSciences Says FDA Grants Fast Track Designation To PBGENE-DMD For Treatment Of Duchenne Muscular Dystrophy

– Fast Track designation aims to facilitate development and expedite review of drugs, such as PBGENE-DMD to treat serious conditions like Duchenne muscular dystrophy –

– March 17, 2026 virtual webinar to feature expert insights on potential clinical utility of PBGENE-DMD for patients with Duchenne muscular dystrophy and the planned Phase 1/2 FUNCTION-DMD clinical study –

Precision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PBGENE-DMD for the treatment of Duchenne muscular dystrophy (DMD). The Company also announced that it will host a virtual key opinion leader (KOL) event on Tuesday, March 17, 2026, at 9:00 AM ET to discuss PBGENE-DMD and the planned Phase 1/2 FUNCTION-DMD clinical study.

Fast Track designation is intended to facilitate the development of investigational therapies for serious conditions with unmet medical need and may support more efficient interactions with the FDA as development advances. Precision believes this designation further underscores the potential of PBGENE-DMD and the urgent need for new DMD treatment options.

In addition, on March 17, 2026, Precision will host an investor event that will feature key DMD leaders Dr. Aravindhan Veerapandiyan, MD, Pediatric Neurologist and Associate Professor of Pediatrics, Arkansas Children's Hospital, and Pat Furlong, Founding President of Parent Project Muscular Dystrophy. Parent Project Muscular Dystrophy (PPMD) is the largest nonprofit organization in the United States focused entirely on Duchenne muscular dystrophy and fights to end Duchenne by advancing research, improving care, and expanding access to therapies. The presenters will discuss the unmet need, current treatment landscape and PBGENE-DMD for Duchenne muscular dystrophy (DMD), including an overview of the clinical trial design for the FUNCTION-DMD trial.