{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-408353","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2026-09-30T12:05:14+00:00","discovered_at":"2026-09-30T12:10:00.288372+00:00","generated_at":"2026-10-12T13:58:07.638541+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Celcuity's REVTORPYK (gedatolisib) now commercially available in US for HR+/HER2- advanced breast cancer","bullets":["FDA approved REVTORPYK on July 14, 2026 as a triplet with palbociclib and fulvestrant, and as a doublet with fulvestrant, for HR+/HER2- ABC without a PIK3CA mutation.","In the Phase 3 VIKTORIA-1 PIK3CA wild-type cohort, the REVTORPYK triplet and doublet cut risk of disease progression or death by 76% and 67% versus fulvestrant.","Celcuity launched REVTORPYK Support Services offering insurance coverage, Copay Assistance and Patient Assistance help; contact 877-423-5284 or www.revtorpykhcp.com.","A supplemental NDA was submitted to the FDA in August for REVTORPYK in HR+/HER2-, PIK3CA-mutated advanced breast cancer based on Study 2 of VIKTORIA-1."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-408353","json":"https://secwatch.observer/filing/0001193125-26-408353.json","markdown":"https://secwatch.observer/filing/0001193125-26-408353.md","text":"https://secwatch.observer/filing/0001193125-26-408353.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000119312526408353/0001193125-26-408353-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000119312526408353/celc-20260930.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:58:07.638541+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"}