FDA clears Precision BioSciences' IND for PBGENE-DMD gene editing therapy for DMD

PRECISION BIOSCIENCES INC

FDA Study May Proceed allows initiation of clinical trial site activation for Phase 1/2 FUNCTION-DMD study in ambulatory DMD patients.
PBGENE-DMD is an in vivo gene excision approach targeting mutations in exons 45-55, covering ~60% of DMD patients.
Aims to restore near full-length dystrophin (80% of full-length), larger than existing micro-dystrophin constructs (~34%).
Company plans to activate first US clinical site in the first half of 2026.
Virtual investor event scheduled for March after MDA conference with key opinion leaders and patient advocates.

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