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Precision BioSciences Receives FDA Fast Track Designation for PBGENE-DMD and Announces Duchenne Muscular Dystrophy Investor Event
– Fast Track designation aims to facilitate development and expedite review of drugs, such as PBGENE-DMD to treat serious conditions like Duchenne muscular
About this update from Precision Biosciences, Inc.
[{"type":"text","content":"\n– Fast Track designation aims to facilitate development and expedite review of drugs, such as PBGENE-DMD to treat serious conditions like Duchenne muscular dystrophy –\n\n\n– 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 –\n\n\n DURHAM, N.C.--(BUSINESS WIRE)--\nPrecision 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.\n\n\n“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. “We believe this designation, together with our recent IND clearance, supports PBGENE-DMD’s continued momentum towards clinical investigation in boys living with DMD.”\n\n\nFast 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.\n\n\nIn 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-...