{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-017043","form_type":"8-K","ticker":"CELC","cik":"0001603454","company_name":"Celcuity Inc.","filed_at":"2025-06-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.977295+00:00","generated_at":"2026-05-18T13:00:13.716263+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Celcuity reports 66% six-month rPFS in mCRPC Phase 1, 43% ORR in HER2+ mBC Phase 2","bullets":["Phase 1 mCRPC (gedatolisib + darolutamide): 66% six-month rPFS; no treatment-related discontinuations or Grade 3 hyperglycemia; Grade 2-3 stomatitis in 10.5% of patients.","Phase 2 HER2+ mBC (gedatolisib + trastuzumab-pkrb): ORR 43%, median PFS 6.0 months, median OS 24.7 months; no discontinuations due to treatment-related AEs; 2.3% Grade 3 hyperglycemia.","Protocol amended to explore additional gedatolisib doses in mCRPC Phase 1/1b; up to six patients per arm in three arms, then Phase 1b with up to 40 patients to determine RP2D.","No prophylaxis for stomatitis used in the mBC trial; data cut-off Feb 10, 2025; results presented at ASCO June 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-017043","json":"https://secwatch.observer/filing/0001641172-25-017043.json","markdown":"https://secwatch.observer/filing/0001641172-25-017043.md","text":"https://secwatch.observer/filing/0001641172-25-017043.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000164117225017043/0001641172-25-017043-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000164117225017043/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T13:00:13.716263+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"}