---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-007114"
form_type: "8-K"
ticker: "DTIL"
cik: "0001357874"
company_name: "PRECISION BIOSCIENCES INC"
filed_at: "2026-02-11T23:59:59+00:00"
generated_at: "2026-05-16T03:15:05.462675+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001628280-26-007114
- form_type: 8-K
- ticker: DTIL
- cik: 0001357874
- company_name: PRECISION BIOSCIENCES INC
- filed_at: 2026-02-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1357874/000162828026007114/0001628280-26-007114-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1357874/000162828026007114/dtil-20260211.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-007114
- JSON: https://secwatch.observer/filing/0001628280-26-007114.json
- Plain text: https://secwatch.observer/filing/0001628280-26-007114.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.