{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-021095","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2025-07-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.467058+00:00","generated_at":"2026-05-18T00:16:30.274955+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"Celcuity Phase 3 VIKTORIA-1 PIK3CA wild-type: gedatolisib triplet cuts progression/death risk by 76% (HR 0.24)","bullets":["Gedatolisib triplet (plus palbociclib/fulvestrant) mPFS 9.3 mo vs 2.0 mo for fulvestrant, incremental gain 7.3 mo.","Gedatolisib doublet (plus fulvestrant) mPFS 7.4 mo vs 2.0 mo, reducing risk by 67% (HR 0.33; p<0.0001).","Treatment discontinuation due to AEs lower than prior Phase 1b; fewer hyperglycemia/stomatitis events.","Celcuity expects to submit NDA to FDA for gedatolisib in Q4 2025; mutation cohort topline by end of 2025.","Efficacy milestones: best HR and mPFS improvement ever reported in any Phase 3 for HR+/HER2- ABC."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-021095","json":"https://secwatch.observer/filing/0001641172-25-021095.json","markdown":"https://secwatch.observer/filing/0001641172-25-021095.md","text":"https://secwatch.observer/filing/0001641172-25-021095.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000164117225021095/0001641172-25-021095-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000164117225021095/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T00:16:30.274955+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"}