{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-25-021903","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2025-11-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.890417+00:00","generated_at":"2026-05-16T21:13:05.562705+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Celcuity Q3 net loss $43.8M; gedatolisib NDA on track for Q4 2025","bullets":["Q3 net loss $43.8M ($0.92 loss per share) vs $29.8M ($0.70 loss) in prior year.","Operating expenses $42.8M (R&D $34.9M, G&A $7.9M), up from $30.1M.","PIK3CA WT cohort: gedatolisib triplet reduced risk of progression/death by 76% (HR 0.24); median PFS 9.3 vs 2.0 months.","FDA accepted NDA under RTOR program; submission for gedatolisib on track for Q4 2025.","PIK3CA mutant cohort fully enrolled; topline data expected late Q1 2026 or Q2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-021903","json":"https://secwatch.observer/filing/0001493152-25-021903.json","markdown":"https://secwatch.observer/filing/0001493152-25-021903.md","text":"https://secwatch.observer/filing/0001493152-25-021903.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000149315225021903/0001493152-25-021903-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000149315225021903/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T21:13:05.562705+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"}