{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-349227","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2026-08-13T20:15:17+00:00","discovered_at":"2026-08-13T20:17:00.366531+00:00","generated_at":"2026-08-13T20:18:00.368774+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Celcuity Q2 net loss $78.9M; FDA approves REVTORPYK, positive PIK3CA MT data","bullets":["FDA approved REVTORPYK (gedatolisib) for HR+/HER2- PIK3CA WT advanced breast cancer on July 14, 2026; launch expected late Q3 2026.","Phase 3 VIKTORIA-1 PIK3CA MT: gedatolisib triplet cut progression/death risk 50% vs alpelisib (HR=0.50, p<0.0001); median PFS 11.1 vs 5.6 months.","Q2 2026 net loss $78.9M ($1.44/share) vs $45.3M ($1.04) prior year; adjusted net loss $58.7M ($1.07) vs $40.5M ($0.93).","Completed $575M convertible notes offering, net proceeds $557.2M; used $137M to prepay term loan debt.","sNDA for PIK3CA MT cohort planned Q3 2026; VIKTORIA-2 expanded to first-line endocrine-sensitive patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-349227","json":"https://secwatch.observer/filing/0001193125-26-349227.json","markdown":"https://secwatch.observer/filing/0001193125-26-349227.md","text":"https://secwatch.observer/filing/0001193125-26-349227.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000119312526349227/0001193125-26-349227-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000119312526349227/celc-20260813.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-13T20:18:00.368774+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"}