{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-033357","form_type":"8-K/A","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2026-07-15T20:05:43+00:00","discovered_at":"2026-07-15T20:08:00.696939+00:00","generated_at":"2026-07-15T20:08:07.728865+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 receives FDA approval for REVTORPYK (gedatolisib) in HR+/HER2- breast cancer","bullets":["FDA approved REVTORPYK for HR+/HER2- PIK3CA wild-type advanced/metastatic breast cancer after endocrine therapy.","In VIKTORIA-1 trial, REVTORPYK triplet reduced risk of progression/death by 76% vs fulvestrant (HR=0.24; median PFS 9.3 vs 2.0 months).","REVTORPYK doublet reduced risk by 67% (HR=0.33; median PFS 7.4 vs 2.0 months).","Commercial launch expected late Q3 2026; sNDA for PIK3CA mutated cohort planned in Q3 2026.","REVTORPYK is first pan-PI3K/mTORC1/2 inhibitor approved by FDA."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-033357","json":"https://secwatch.observer/filing/0001493152-26-033357.json","markdown":"https://secwatch.observer/filing/0001493152-26-033357.md","text":"https://secwatch.observer/filing/0001493152-26-033357.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226033357/0001493152-26-033357-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226033357/form8-ka.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-15T20:08:07.728865+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"}