{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-109644","form_type":"8-K","ticker":"CRNX","cik":"0001658247","company_name":"Crinetics Pharmaceuticals, Inc.","filed_at":"2024-09-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.002408+00:00","generated_at":"2026-05-31T01:34:54.002183+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Crinetics submits NDA to FDA for paltusotine for acromegaly; Phase 3 data support submission","bullets":["NDA supported by 18 clinical trials including two Phase 3 PATHFNDR studies; all primary and secondary endpoints met.","FDA notification on NDA acceptance expected in December 2024.","Paltusotine is first once-daily oral SST2 nonpeptide agonist in development for acromegaly.","Drug also in Phase 2 for carcinoid syndrome associated with neuroendocrine tumors.","CEO states submission is a key step toward delivering a new therapy for the acromegaly community."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-109644","json":"https://secwatch.observer/filing/0000950170-24-109644.json","markdown":"https://secwatch.observer/filing/0000950170-24-109644.md","text":"https://secwatch.observer/filing/0000950170-24-109644.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1658247/000095017024109644/0000950170-24-109644-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1658247/000095017024109644/crnx-20240926.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T01:34:54.002183+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"}