{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-107273","form_type":"8-K","ticker":"SRRK","cik":"0001727196","company_name":"Scholar Rock Holding Corp","filed_at":"2026-09-14T12:00:27+00:00","discovered_at":"2026-09-14T12:05:00.759607+00:00","generated_at":"2026-09-14T12:05:32.019320+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"FDA approves Scholar Rock's ISEMBYLD (apitegromab) for SMA in adults and children ≥2 years","bullets":["FDA approved ISEMBYLD (apitegromab-mstn) for SMA in adults/children ≥2 yrs on SMN2-targeted therapy.","Phase 3 SAPPHIRE: 2.2-point HFMSE improvement vs placebo (nominal p=0.0121); 34.2% ≥3-point gain vs 13.5% (OR 3.8).","Safety: fractures 9% ISEMBYLD vs 2% placebo; database >500, some treated >7 years.","U.S. launch underway, shipping in coming days; awarded Rare Pediatric Disease Priority Review Voucher."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-107273","json":"https://secwatch.observer/filing/0001104659-26-107273.json","markdown":"https://secwatch.observer/filing/0001104659-26-107273.md","text":"https://secwatch.observer/filing/0001104659-26-107273.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/0001104659-26-107273-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-14T12:05:32.019320+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"}