{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-012668","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2026-03-25T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.606988+00:00","generated_at":"2026-05-15T09:00:46.883962+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Celcuity reports Q4 loss $0.97/share; FDA grants Priority Review for gedatolisib, PDUFA July 17, 2026","bullets":["Net loss Q4 $51.0M ($0.97), FY $177.0M ($3.79); adjusted net loss Q4 $38.4M ($0.73), FY $150.8M ($3.22).","FDA accepted NDA for gedatolisib in HR+/HER2-/PIK3CA WT advanced breast cancer, granted Priority Review; PDUFA goal date July 17, 2026.","Topline results from PIK3CA mutant cohort of Phase 3 VIKTORIA-1 expected in Q2 2026.","Updated efficacy/safety results from PIK3CA WT cohort published in Journal of Clinical Oncology in March 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-012668","json":"https://secwatch.observer/filing/0001493152-26-012668.json","markdown":"https://secwatch.observer/filing/0001493152-26-012668.md","text":"https://secwatch.observer/filing/0001493152-26-012668.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226012668/0001493152-26-012668-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226012668/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T09:00:46.883962+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":[{"claim_id":"4626c04d94c944390a76afb30d0b19750828a5f6","claim":"Celcuity Inc. reported financial results for the fourth quarter and fiscal year ended December 31, 2025.","evidence_excerpt":"On March 25, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the fourth quarter and fiscal year ended December 31, 2025.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226012668/0001493152-26-012668-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the fourth quarter and fiscal year ended December 31, 2025"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}