{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-365975","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2026-08-26T12:35:14+00:00","discovered_at":"2026-08-26T12:40:01.407607+00:00","generated_at":"2026-08-26T12:40:07.114613+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Celcuity files sNDA for REVTORPYK in PIK3CA-mutant advanced breast cancer","bullets":["sNDA seeks FDA approval for REVTORPYK (gedatolisib) in HR+/HER2- ABC with PIK3CA mutation after ≥1 endocrine therapy.","Phase 3 VIKTORIA-1: triplet cut progression/death risk by 50% vs alpelisib+fulvestrant (HR=0.50, p<0.0001); median PFS 11.1 vs 5.6 months.","Doublet: HR=0.51 (p=0.0013), median PFS 11.3 vs 5.6 months; ORR 49% (triplet) and 36% (doublet).","If approved, first therapy for PIK3CA-mutant ABC inhibiting all class I PI3K isoforms and mTORC1/C2.","FDA approved REVTORPYK for PIK3CA wild-type ABC on July 14, 2026; this submission expands to mutant population."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-365975","json":"https://secwatch.observer/filing/0001193125-26-365975.json","markdown":"https://secwatch.observer/filing/0001193125-26-365975.md","text":"https://secwatch.observer/filing/0001193125-26-365975.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000119312526365975/0001193125-26-365975-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000119312526365975/celc-20260826.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-26T12:40:07.114613+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"}