{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-018565","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2025-10-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.890174+00:00","generated_at":"2026-05-17T03:13:53.336839+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Phase 3 VIKTORIA-1 data: gedatolisib triplet reduces progression risk by 76% in HR+/HER2- ABC","bullets":["Median PFS 9.3mo for gedatolisib triplet vs 2.0mo for fulvestrant (HR=0.24); incremental 7.3mo improvement.","ORR 31.5% for triplet vs 1% for fulvestrant; median DOR 17.5mo.","Rolling NDA submission started under FDA RTOR; completion targeted Q4 2025.","PIK3CA mutant cohort fully enrolled; topline expected late Q1 2026 or Q2 2026.","Phase 1b data: median PFS 14.6mo in PIK3CA mutant patients overall, 19.7mo with intermittent dose."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-018565","json":"https://secwatch.observer/filing/0001493152-25-018565.json","markdown":"https://secwatch.observer/filing/0001493152-25-018565.md","text":"https://secwatch.observer/filing/0001493152-25-018565.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000149315225018565/0001493152-25-018565-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000149315225018565/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:13:53.336839+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"}