{"filing":{"accession_number":"0001193125-26-365975","cik":"0001603454","ticker":"CELC","company_name":"Celcuity Inc.","form":"8-K","filing_date":"2026-08-26","report_date":"2026-08-26","primary_document":"celc-20260826.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1603454/000119312526365975/celc-20260826.htm"},"events":[{"id":29648,"run_id":27164,"accession_number":"0001193125-26-365975","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"Celcuity announced submission of a supplemental New Drug Application (sNDA) to the FDA for REVTORPYK (gedatolisib) for HR+/HER2- breast cancer with PIK3CA mutations, representing a material regulatory milestone and significant step toward expanding the approved indication for the already-approved drug based on positive Phase 3 VIKTORIA-1 trial results.","company_name":"Celcuity Inc.","ticker":"CELC","filing_date":"2026-08-26","form":"8-K","submitted_at":null,"items":[{"id":32002,"accession_number":"0001193125-26-365975","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Celcuity announced submission of a supplemental New Drug Application (sNDA) to the FDA for REVTORPYK (gedatolisib) for HR+/HER2- breast cancer with PIK3CA mutations. This is a material regulatory milestone for a biotechnology company—the sNDA submission represents a significant step toward expanding the approved indication for an already-approved drug based on positive Phase 3 VIKTORIA-1 trial results. While not a traditional M\u0026A or financial event, this regulatory filing is operationally and strategically material to investors assessing the company's pipeline and commercial prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-26T12:36:43.853030+00:00","company_name":"","ticker":null,"filing_date":""},{"id":32003,"accession_number":"0001193125-26-365975","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Celcuity announced submission of a supplemental New Drug Application (sNDA) to the FDA for REVTORPYK for an expanded indication in HR+/HER2- ABC patients with PIK3CA mutations. This is a material regulatory milestone for a biotechnology company—the sNDA submission represents a significant operational and strategic event that could expand the addressable market for an already-approved product. While not a traditional M\u0026A, earnings release, or executive change, the regulatory submission of a label expansion application is a material operational event that would affect investor assessment of the company's growth prospects and product pipeline.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-26T12:36:43.853030+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":32002,"accession_number":"0001193125-26-365975","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Celcuity announced submission of a supplemental New Drug Application (sNDA) to the FDA for REVTORPYK (gedatolisib) for HR+/HER2- breast cancer with PIK3CA mutations. This is a material regulatory milestone for a biotechnology company—the sNDA submission represents a significant step toward expanding the approved indication for an already-approved drug based on positive Phase 3 VIKTORIA-1 trial results. While not a traditional M\u0026A or financial event, this regulatory filing is operationally and strategically material to investors assessing the company's pipeline and commercial prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-26T12:36:43.853030+00:00","company_name":"Celcuity Inc.","ticker":"CELC","filing_date":"2026-08-26"},{"id":32003,"accession_number":"0001193125-26-365975","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Celcuity announced submission of a supplemental New Drug Application (sNDA) to the FDA for REVTORPYK for an expanded indication in HR+/HER2- ABC patients with PIK3CA mutations. This is a material regulatory milestone for a biotechnology company—the sNDA submission represents a significant operational and strategic event that could expand the addressable market for an already-approved product. While not a traditional M\u0026A, earnings release, or executive change, the regulatory submission of a label expansion application is a material operational event that would affect investor assessment of the company's growth prospects and product pipeline.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-26T12:36:43.853030+00:00","company_name":"Celcuity Inc.","ticker":"CELC","filing_date":"2026-08-26"}]}