{"url_path":"/sec/celc/8-k/2026-07-15/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 ** **Other Events.**","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":541,"has_tables":true,"body_markdown":"**Item 8.01** **Other Events.**\n\n \n\nOn\nJuly 14, 2026, the Company issued a press release announcing FDA approval of REVTORPYK for the treatment of patients with HR+/HER2-,\nlocally advanced or metastatic breast cancer without a *PIK3CA* mutation detected following progression on or after treatment with\nat least one line of endocrine therapy in the metastatic setting. The Company anticipates commercial launch of REVTORPYK in late Q3 2026.\n\n \n\nThe\nCompany plans to submit in Q3 2026 a supplemental New Drug Application (“sNDA”) to the FDA for REVTORPYK for the treatment\nof HR+/HER2-, *PIK3CA* mutated, locally advanced or metastatic breast cancer, following at least one line of endocrine therapy based\non results from the mutant cohort of the Phase 3 VIKTORIA-1 trial.\n\n \n\nSlide\n18 of Exhibit 99.2 to this Current Report on Form 8-K is hereby incorporated by reference into this Item 8.01.\n\n \n\n**Forward-Looking\nStatements**\n\n \n\nThis\nCurrent Report on Form 8-K (including the exhibit thereto) contains statements that constitute “forward-looking statements”\nwithin the meaning of the Private Securities Litigation Reform Act of 1995 relating to the potential therapeutic benefits of gedatolisib;\nthe size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the status\nand timing of the submission, and the FDA’s review, of the Company’s sNDA for gedatolisib, and for making comparable filings\nwith other regulatory authorities outside the U.S.; the market opportunity for gedatolisib; the Company’s expectations regarding\nthe timing of and its ability to commercialize gedatolisib; the Company’s strategy, marketing and commercialization plans, including\nthe benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including subcutaneous\nformulations to support potential future indications for gedatolisib regimens; the Company’s anticipated use of cash; and the strength\nof its balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,”\n“anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,”\n“plan,” “targets,” “likely,” “may,” “will,” “would,” “should”\nand “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included\nin this report are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties\nand factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data\nand such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s\nclinical trials or the submission, and FDA’s review of, its sNDA for gedatolisib; the Company’s ability to obtain regulatory\napproval of its sNDA and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development\nof therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition,\nall forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended\nDecember 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned\nnot to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements\nare qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this report\nto reflect events or circumstances after the date hereof."}