Common Stock, $0.001 par value per share
- Symbol
- CELC
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 2.02, 9.01 · 8-K
Celcuity Inc.
CELCNASDAQEQUITYCurrent
Results of Operations and Financial Condition
Item 2.02 Results of Operations and Financial Condition. On November 05, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the quarter ended September 30, 2026. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.…
Press release in this filing
Celcuity Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate Update →Company context
Celcuity is a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. Celcuity’s first FDA-approved product is REVTORPYK™ (gedatolisib), a potent pan-PI3K and mTORC1/2 inhibitor that comprehensively blocks the PI3K/AKT/mTOR (PAM) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1, alone or together. Celcuity’s Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, supported FDA approval of REVTORPYK for use in adult patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 clinical trial have been released.
Current securities
Registered securities in this filing
Celcuity Inc. · 8-K · Filed 2026-11-05
Disclosure sections
Item 2.02Item 2.02 - Results of Operations
Item 2.02 Results of Operations and Financial Condition.
On November 05, 2026, Celcuity Inc. (the “Company”) issued a press release regarding the Company’s financial results for the quarter ended September 30, 2026. A copy of the Company’s press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 2.02 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Filed exhibits (1)
Exhibit 99.1 Celcuity Inc. Reports Third Quarter 2026 Financial Results and Provides Corporate Update REVTORPYK became commercially available on September 30th for the treatment of patients with HR+/HER2- PIK3CA wild-type locally advanced or metastatic breast cancer 91% of U.S. commercial and Medicare lives are in health plans that cover REVTORPYK 78% of the top 36 strategic accounts, representing ~50% of the total addressable patient population, have prescribed REVTORPYK Management to host webcast and conference call today, November 5, 2026, at 4:30 p.m. EST MINNEAPOLIS, November 5, 2026 - Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced financial results for the third quarter ended September 30, 2026, and other recent business developments. Celcuity announced on September 30, 2026, that REVTORPYK™ (gedatolisib) became commercially available in the United States for use in combination with fulvestrant, with or without palbociclib, for the treatment of HR+/HER2- locally advanced or metastatic breast cancer (“ABC”) without a…
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