{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-23-029858","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2023-08-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.516286+00:00","generated_at":"2026-06-11T05:37:13.275507+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Celcuity to start Phase 1b/2 trial of gedatolisib + darolutamide in mCRPC; Bayer supplies drug free","bullets":["FDA cleared IND for gedatolisib in combination with darolutamide; trial to begin Q1 2024.","Phase 1b/2 study CELC-G-201 will enroll up to 54 mCRPC patients who progressed after first-line AR inhibitor.","Bayer will provide Nubeqa (darolutamide) at no cost under clinical trial collaboration and supply agreement.","Virtual Science Day scheduled for September 21, 2023 (10:00 a.m. – 12:00 p.m. ET) with key opinion leaders."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-23-029858","json":"https://secwatch.observer/filing/0001493152-23-029858.json","markdown":"https://secwatch.observer/filing/0001493152-23-029858.md","text":"https://secwatch.observer/filing/0001493152-23-029858.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000149315223029858/0001493152-23-029858-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000149315223029858/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-11T05:37:13.275507+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"}