Precision BioSciences (DTIL) announced the FDA has granted Orphan Drug Designation for PBGENE-DMD for the treatment of Duchenne muscular dystrophy. PBGENE-DMD was recently granted FDA Rare Pediatric Disease designation for the treatment of DMD.
Cindy Atwell, Chief Development and Business Officer at Precision BioSciences, said: "Looking ahead, we remain in active dialogue with the FDA as we advance PBGENE-DMD toward regulatory milestones, with clinical data anticipated in 2026."
Shares of Precision BioSciences are up 6% in pre-market trade on Wednesday.
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