{"filing":{"accession_number":"0001493152-26-026761","cik":"0001603454","ticker":"CELC","company_name":"Celcuity Inc.","form":"8-K","filing_date":"2026-06-02","report_date":null,"primary_document":"form8-k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226026761/form8-k.htm"},"events":[{"id":7570,"run_id":6653,"accession_number":"0001493152-26-026761","anchor_item_number":null,"event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"summary":"Celcuity disclosed detailed Phase 3 clinical trial results for gedatolisib (VIKTORIA-1) showing statistically significant efficacy improvements over a comparator drug, with the company anticipating FDA approval in Q3 2026 and commercial launch. While this is a material clinical milestone for a biotech company with an NDA under Priority Review, it does not fit neatly into the standard 8-K event taxonomy—it is neither an earnings release (no financial results), nor a regulatory approval (approval is anticipated, not granted), nor a material impairment or litigation. The disclosure is clearly material to investors assessing the company's pipeline and regulatory prospects, warranting classification as other_material.","company_name":"Celcuity Inc.","ticker":"CELC","filing_date":"2026-06-02","form":"8-K","submitted_at":null,"items":null}],"classifications":[{"id":3707,"accession_number":"0001493152-26-026761","item_number":null,"item_title":null,"event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"Celcuity disclosed detailed Phase 3 clinical trial results for gedatolisib (VIKTORIA-1) showing statistically significant efficacy improvements over a comparator drug, with the company anticipating FDA approval in Q3 2026 and commercial launch. While this is a material clinical milestone for a biotech company with an NDA under Priority Review, it does not fit neatly into the standard 8-K event taxonomy—it is neither an earnings release (no financial results), nor a regulatory approval (approval is anticipated, not granted), nor a material impairment or litigation. The disclosure is clearly material to investors assessing the company's pipeline and regulatory prospects, warranting classification as other_material.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-06-03T02:41:33.932005+00:00","company_name":"Celcuity Inc.","ticker":"CELC","filing_date":"2026-06-02"}]}
