{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-029354","form_type":"8-K","ticker":"SRPT","cik":"0000873303","company_name":"Sarepta Therapeutics, Inc.","filed_at":"2023-06-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:42.500475+00:00","generated_at":"2026-06-13T19:34:01.267585+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"FDA grants accelerated approval for Sarepta's ELEVIDYS gene therapy for Duchenne MD","bullets":["First FDA-approved gene therapy for Duchenne muscular dystrophy; for ambulatory patients aged 4-5.","Accelerated approval based on micro-dystrophin expression; confirmatory trial EMBARK reads out late 2023.","Contraindicated in patients with deletions in exon 8 and/or 9 of the DMD gene.","Common adverse reactions include vomiting, nausea, liver enzyme increases, pyrexia, thrombocytopenia."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-029354","json":"https://secwatch.observer/filing/0000950170-23-029354.json","markdown":"https://secwatch.observer/filing/0000950170-23-029354.md","text":"https://secwatch.observer/filing/0000950170-23-029354.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/873303/000095017023029354/0000950170-23-029354-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/873303/000095017023029354/srpt-20230622.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T19:34:01.267585+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"}