{"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","discovered_at":"2026-05-14T18:02:46.532401+00:00","generated_at":"2026-05-18T05:28:55.817674+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA places clinical hold on Sarepta's LGMD gene therapy trials; revokes AAVrh74 platform designation","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-161516","json":"https://secwatch.observer/filing/0001193125-25-161516.json","markdown":"https://secwatch.observer/filing/0001193125-25-161516.md","text":"https://secwatch.observer/filing/0001193125-25-161516.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T05:28:55.817674+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}