{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-023897","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2025-11-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.890660+00:00","generated_at":"2026-05-16T19:15:51.133240+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":"Celcuity completes NDA submission to FDA for gedatolisib in HR+/HER2- advanced breast cancer under RTOR program","bullets":["NDA submitted for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer.","Submitted under FDA's RTOR program; drug previously received Breakthrough Therapy and Fast Track designations.","Phase 3 VIKTORIA-1: triplet reduced risk of progression/death by 76% (HR 0.24); median PFS 9.3 mo vs 2.0 mo.","Doublet (gedatolisib + fulvestrant) reduced risk by 67% (HR 0.33); median PFS 7.4 mo vs 2.0 mo.","CEO Sullivan: 'unprecedented efficacy results and overall safety profile are potentially practice changing.'"],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-023897","json":"https://secwatch.observer/filing/0001493152-25-023897.json","markdown":"https://secwatch.observer/filing/0001493152-25-023897.md","text":"https://secwatch.observer/filing/0001493152-25-023897.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000149315225023897/0001493152-25-023897-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000149315225023897/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T19:15:51.133240+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"}