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PRECISION BIOSCIENCES INC 8K

0001628280-26-058512

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Precision BioSciences has dosed the first patient in its Phase 1/2 FUNCTION-DMD trial of PBGENE-DMD, an in vivo gene-editing therapy for Duchenne muscular dystrophy, with initial safety data expected by year-end 2026.

Precision BioSciences, Inc. announced that it has commenced dosing in its Phase 1/2 FUNCTION-DMD clinical trial by treating the first patient in August 2026 with PBGENE-DMD, its wholly owned in vivo gene-editing therapy designed to excise exons 45-55 of the dystrophin gene using dual ARCUS nucleases delivered in a single AAV vector, with the goal of restoring near full-length functional dystrophin in ambulatory boys aged 2 to 7 with Duchenne muscular dystrophy mutations in this hotspot region; the first patient was dosed at Arkansas Children’s Hospital, and the company expects to report initial safety data from the study by year-end 2026, supported by Orphan Drug and Fast Track designations and eligibility for a Rare Pediatric Disease Priority Review Voucher.

Filing Facts

CIK
1357874
Ticker
-
Form
8K
Source Type
sec
Accession
0001628280-26-058512
Alert Tier
6
PRECISION BIOSCIENCES INC 8K | ATTN