{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-117522","form_type":"8-K","ticker":"SRRK","cik":"0001727196","company_name":"Scholar Rock Holding Corp","filed_at":"2025-12-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.266539+00:00","generated_at":"2026-05-16T15:45:24.865313+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Scholar Rock manufacturing partner Catalent Indiana receives FDA Warning Letter; 2026 apitegromab launch still expected","bullets":["Catalent Indiana (Novo Nordisk) received FDA Warning Letter for facility with 'official action indicated' classification.","Scholar Rock reiterates expectation to resubmit BLA for apitegromab in SMA and achieve U.S. launch in 2026.","Company continues to collaborate with Catalent to resolve FDA issues; no change to prior timeline."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-117522","json":"https://secwatch.observer/filing/0001104659-25-117522.json","markdown":"https://secwatch.observer/filing/0001104659-25-117522.md","text":"https://secwatch.observer/filing/0001104659-25-117522.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1727196/000110465925117522/0001104659-25-117522-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1727196/000110465925117522/tm2532170d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T15:45:24.865313+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"}