{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-037350","form_type":"8-K","ticker":"SRRK","cik":"0001727196","company_name":"Scholar Rock Holding Corp","filed_at":"2026-03-31T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.015892+00:00","generated_at":"2026-05-15T08:11:51.324542+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Scholar Rock resubmits BLA for apitegromab SMA; PDUFA goal late Sept 2026","bullets":["Resubmission follows Sep 2025 CRL related to Catalent Indiana facility; no other approvability concerns cited.","FDA acceptance expected within 30 days; review up to 6 months; PDUFA decision target late September 2026.","Includes second U.S. fill-finish facility after positive Type C meeting on March 3, 2026.","European MAA for apitegromab progressing; decision anticipated mid-2026.","CEO David L. Hallal expects U.S. and European approvals and launches this year."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-037350","json":"https://secwatch.observer/filing/0001104659-26-037350.json","markdown":"https://secwatch.observer/filing/0001104659-26-037350.md","text":"https://secwatch.observer/filing/0001104659-26-037350.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1727196/000110465926037350/0001104659-26-037350-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1727196/000110465926037350/tm2610664d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T08:11:51.324542+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"}