{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-092317","form_type":"8-K","ticker":"SRRK","cik":"0001727196","company_name":"Scholar Rock Holding Corp","filed_at":"2025-09-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.816046+00:00","generated_at":"2026-05-17T05:53:17.906483+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA issues CRL for Scholar Rock's apitegromab BLA due to Catalent fill-finish observations","bullets":["CRL cites observations at Catalent Indiana fill-finish facility; no efficacy/safety issues.","Scholar Rock intends to resubmit BLA upon resolution of Catalent remediation.","Catalent submitted comprehensive response in August 2025; FDA kept apprised of progress.","EU MAA under review; decision expected mid-2026; launch anticipated H2 2026 in Germany first."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-092317","json":"https://secwatch.observer/filing/0001104659-25-092317.json","markdown":"https://secwatch.observer/filing/0001104659-25-092317.md","text":"https://secwatch.observer/filing/0001104659-25-092317.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/0001104659-25-092317-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/tm2526733d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:53:17.906483+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"}