---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-161516"
form_type: "8-K"
ticker: "SRPT"
cik: "0000873303"
company_name: "Sarepta Therapeutics, Inc."
filed_at: "2025-07-21T23:59:59+00:00"
generated_at: "2026-05-18T05:28:55.817674+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA places clinical hold on Sarepta's LGMD gene therapy trials; revokes AAVrh74 platform designation

## Summary
- FDA placed clinical hold on LGMD trials for SRP-9003, SRP-9004, SRP-6004, and SRP-9005.
- Sarepta had paused most LGMD programs on July 16, 2025; SRP-9003 was excepted.
- FDA revoked AAVrh74 platform technology designation previously granted on June 2, 2025.
- Sarepta plans to discuss accelerated approval pathway for SRP-9003 after clinical hold lifted.
- Enrollment and dosing in Phase 3 trial SRP-9003-301 was completed in December 2024.

## SEC filing metadata
- accession: 0001193125-25-161516
- form_type: 8-K
- ticker: SRPT
- cik: 0000873303
- company_name: Sarepta Therapeutics, Inc.
- filed_at: 2025-07-21T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/873303/000119312525161516/0001193125-25-161516-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/873303/000119312525161516/d882671d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-161516
- JSON: https://secwatch.observer/filing/0001193125-25-161516.json
- Plain text: https://secwatch.observer/filing/0001193125-25-161516.txt

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