Shares of Precision BioSciences (NASDAQ:DTIL) rose 13% on Monday after the U.S. Food and Drug Administration granted Fast Track designation to PBGENE-DMD, the company’s gene-editing therapy for Duchenne muscular dystrophy.
The Fast Track designation is intended to accelerate the development and regulatory review of treatments for serious conditions. It also enables more frequent interactions with the FDA as the therapy advances through clinical development.
“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 secured IND clearance for PBGENE-DMD and plans to begin a Phase 1/2 clinical trial known as FUNCTION-DMD. Precision BioSciences is developing the therapy using its proprietary ARCUS gene-editing platform designed for in vivo treatments.
The Durham, North Carolina-based biotech firm also announced it will hold a virtual event on March 17, 2026. The event will feature Dr. Aravindhan Veerapandiyan, Pediatric Neurologist and Associate Professor of Pediatrics at Arkansas Children’s Hospital, along with Pat Furlong, Founding President of Parent Project Muscular Dystrophy.
The discussion will focus on the current treatment landscape for Duchenne muscular dystrophy and outline the design of the upcoming FUNCTION-DMD clinical study.
Duchenne muscular dystrophy is a genetic disease that leads to progressive muscle degeneration and weakness and primarily affects boys.