{"schema_version":"secwatch.filing_event.v1","accession":"0001658247-25-000008","form_type":"8-K","ticker":"CRNX","cik":"0001658247","company_name":"Crinetics Pharmaceuticals, Inc.","filed_at":"2025-09-26T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.579763+00:00","generated_at":"2026-05-17T05:34:12.137036+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Crinetics gets FDA approval for PALSONIFY (paltusotine) as first oral acromegaly treatment","bullets":["FDA approved PALSONIFY (paltusotine) for adults with acromegaly with inadequate response to surgery or not surgical candidates.","First once-daily oral SST2 agonist; approval based on Phase 3 PATHFNDR-1/2 trials showing rapid, durable biochemical control and reduced symptom burden.","Product expected available in U.S. early October; CrinetiCARE support program launched for patients.","MAA under review in EU (CHMP opinion H1 2026); also evaluating paltusotine in Phase 3 CAREFNDR trial for carcinoid syndrome.","Investor conference call on Sept 25, 2025 at 6:00 pm ET to discuss FDA approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001658247-25-000008","json":"https://secwatch.observer/filing/0001658247-25-000008.json","markdown":"https://secwatch.observer/filing/0001658247-25-000008.md","text":"https://secwatch.observer/filing/0001658247-25-000008.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1658247/000165824725000008/0001658247-25-000008-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1658247/000165824725000008/crnx-20250925.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:34:12.137036+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"}