{"url_path":"/sec/celc/8-k/2026-07-15/item-7-01","section_key":"item-7-01","section_title":"Item 7.01 ** **Regulation FD Disclosure.**","topic":"sec","document":{"doc_type":"8-K/A","doc_date":"2026-07-15","source_url":"https://www.sec.gov/Archives/edgar/data/1603454/0001493152-26-033357-index.html","accession_number":"0001493152-26-033357","cik":"0001603454","ticker":"CELC","issuer_name":"Celcuity Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1603454/0001493152-26-033357-index.html","primary_entity_key":"0001603454","primary_entity_name":"Celcuity Inc."},"word_count":223,"has_tables":true,"body_markdown":"**Item 7.01** **Regulation FD Disclosure.**\n\n \n\nOn\nJuly 14, 2026, the Company issued a press release announcing U.S. Food and Drug Administration (“FDA”) approval of REVTORPYK™\n(gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor\n2 negative (“HER2-”), locally advanced or metastatic breast cancer without a *PIK3CA* mutation detected following progression\non or after treatment with at least one line of endocrine therapy in the metastatic setting. A copy of this press release is furnished\nas Exhibit 99.1 to this report and is incorporated herein by reference. The Company hosted a live webcast and conference call\non July 14, 2026, at 4:30 p.m. CT to discuss the FDA approval of REVTORPYK. A copy of the presentation that was provided during\nthe live webcast is furnished as Exhibit 99.2 to this report and is incorporated herein by reference.\n\n \n\nThe\ninformation in this Item 7.01, including the accompanying exhibits, is being furnished and shall not be deemed “filed” for\npurposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the\nliabilities of that Section. The information in this Item 7.01 shall not be incorporated into any filing pursuant to the Securities Act\nof 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing."}