{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-338184","form_type":"8-K","ticker":"CORT","cik":"0001088856","company_name":"CORCEPT THERAPEUTICS INC","filed_at":"2025-12-31T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.765748+00:00","generated_at":"2026-05-16T11:52:45.639244+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.78,"calibrated_materiality_score":0.78,"confidence":"high","headline":"FDA issues Complete Response Letter for Corcept's relacorilant NDA in hypercortisolism","bullets":["FDA concluded benefit-risk assessment unfavorable without additional effectiveness evidence.","Pivotal GRACE trial met primary endpoint; GRADIENT trial provided confirmatory evidence.","CEO Joseph Belanoff expressed surprise and disappointment; plans to meet with FDA.","Relacorilant was under review for hypertension secondary to hypercortisolism."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-338184","json":"https://secwatch.observer/filing/0001193125-25-338184.json","markdown":"https://secwatch.observer/filing/0001193125-25-338184.md","text":"https://secwatch.observer/filing/0001193125-25-338184.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1088856/000119312525338184/0001193125-25-338184-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1088856/000119312525338184/d50993d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:52:45.639244+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"}