{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-107721","form_type":"8-K","ticker":"SRRK","cik":"0001727196","company_name":"Scholar Rock Holding Corp","filed_at":"2026-09-15T12:30:50+00:00","discovered_at":"2026-09-15T12:35:00.314804+00:00","generated_at":"2026-09-15T12:35:23.179755+00:00","sec_items":["7.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves Scholar Rock's ISEMBYLD for SMA; company clarifies post-marketing safety commitments","bullets":["FDA approved ISEMBYLD (apitegromab-mstn) for spinal muscular atrophy in adults/children 2+ on SMN2-targeted treatment.","Corrects prior statement: FDA requires a pregnancy safety study and 15-day fracture alert reports as post-marketing commitments.","Scholar Rock will conduct the study and submit fracture reports in compliance with FDA's request."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-107721","json":"https://secwatch.observer/filing/0001104659-26-107721.json","markdown":"https://secwatch.observer/filing/0001104659-26-107721.md","text":"https://secwatch.observer/filing/0001104659-26-107721.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1727196/000110465926107721/0001104659-26-107721-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1727196/000110465926107721/tm2625438d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-15T12:35:23.179755+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"}