{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-134342","form_type":"8-K","ticker":"CRNX","cik":"0001658247","company_name":"Crinetics Pharmaceuticals, Inc.","filed_at":"2024-12-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.131221+00:00","generated_at":"2026-05-29T05:40:59.497619+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Crinetics announces FDA acceptance of NDA for paltusotine in acromegaly; PDUFA Sept 25, 2025","bullets":["FDA accepted Crinetics' NDA for once-daily oral paltusotine for adult acromegaly patients.","PDUFA target action date set for September 25, 2025; no advisory committee meeting planned.","NDA included Phase 3 PATHFNDR-1 and PATHFNDR-2 trials evaluating safety and efficacy.","Paltusotine granted Orphan Drug Designation by FDA in July 2020 for acromegaly.","If approved, paltusotine would be first once-daily oral SST2 nonpeptide agonist for acromegaly."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-134342","json":"https://secwatch.observer/filing/0000950170-24-134342.json","markdown":"https://secwatch.observer/filing/0000950170-24-134342.md","text":"https://secwatch.observer/filing/0000950170-24-134342.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1658247/000095017024134342/0000950170-24-134342-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1658247/000095017024134342/crnx-20241209.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T05:40:59.497619+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"}