Common Stock, $0.001 par value per share
- Symbol
- CELC
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 8.01, 9.01 · 8-K
Celcuity Inc.
CELCNASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 7.01 Regulation FD Disclosure. On September 30, 2026, Celcuity Inc. (the "Company") issued a press release announcing that REVTORPYK™ (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor-positive (“HR+”), human epidermal growth factor receptor 2-negative (“HER2-”), locally advanced or metastatic breast cancer ("ABC") without a PIK3CA mut…
Press release in this filing
Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States →Company context
Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the 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. A Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC 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 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients w
Current securities
Registered securities in this filing
Celcuity Inc. · 8-K · Filed 2026-09-30
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On September 30, 2026, Celcuity Inc. (the "Company") issued a press release announcing that REVTORPYK™ (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor-positive (“HR+”), human epidermal growth factor receptor 2-negative (“HER2-”), locally advanced or metastatic breast cancer ("ABC") without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. A copy of this press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information in this Item 7.01, including the accompanying exhibits, 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 7.01 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.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On September 30, 2026, the Company issued a press release announcing that REVTORPYK is now commercially available in the United States for eligible patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Filed exhibits (1)
Exhibit 99.1 Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States • REVTORPYK is indicated for patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting • REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, to comprehensively blockade the PI3K/AKT/mTOR (“PAM”) pathway • In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, the REVTORPYK triplet and REVTORPYK doublet reduced the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant • Healthcare providers can visit www.revtorpykhcp.com to access a comprehensive patient support program through REVTORPYK Support Services MINNEAPOLIS, September 30, 2026 - Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that REVTORPYK™ (gedatolisib) is now commercially available in the United States for eligib…
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