{"filing":{"accession_number":"0001493152-26-033223","cik":"0001603454","ticker":"CELC","company_name":"Celcuity Inc.","form":"8-K","filing_date":"2026-07-14","report_date":null,"primary_document":"form8-k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226033223/form8-k.htm"},"events":[{"id":17959,"run_id":16111,"accession_number":"0001493152-26-033223","anchor_item_number":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The filing discloses FDA approval of REVTORPYK (gedatolisib) for HR+/HER2- breast cancer and the company's anticipated commercial launch in late Q3 2026, along with plans to submit a supplemental NDA for PIK3CA-mutated patients. This is a material regulatory milestone and product approval event that does not fit neatly into the standard financial, governance, or legal categories—it is primarily an operational/strategic business milestone involving regulatory approval and commercialization of the company's lead product candidate.","company_name":"Celcuity Inc.","ticker":"CELC","filing_date":"2026-07-14","form":"8-K","submitted_at":null,"items":null}],"classifications":[{"id":16624,"accession_number":"0001493152-26-033223","item_number":null,"item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The filing discloses FDA approval of REVTORPYK (gedatolisib) for HR+/HER2- breast cancer and the company's anticipated commercial launch in late Q3 2026, along with plans to submit a supplemental NDA for PIK3CA-mutated patients. This is a material regulatory milestone and product approval event that does not fit neatly into the standard financial, governance, or legal categories—it is primarily an operational/strategic business milestone involving regulatory approval and commercialization of the company's lead product candidate.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-15T10:01:40.670319+00:00","company_name":"Celcuity Inc.","ticker":"CELC","filing_date":"2026-07-14"}]}