Celcuity

CELC

시가총액 US$27.7억

ADDYY, CELC and CNL have been added to the Zacks Rank #5 (Strong Sell) List on October 14, 2026.

Rapid oral presentation of additional sub-group analyses from the VIKTORIA-1 PIK3CA mutant-type cohort Poster presentation of a comparative analysis of data for the gedatolisib triplet from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer Poster presentation of sub-group analyses from the Phase 1b trial of gedatolisib plus darolutamide in patients with mCRPC MINNEAPOLIS, Oct. 05, 2026 (GLOBE NEWSWIRE) -- 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 a late breaking rapid oral presentation and three poster presentations will be featured at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2026 being held October 23-27, 2026, in Madrid, Spain. Data from its clinical trials of gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”) and metastatic castration-resistant prostate cancer (“mCRPC”) will be presented.

Mr. Gryska brings decades of strategic and financial leadership experience to Celcuity's Board Mr. Gryska brings decades of strategic and financial leadership experience to Celcuity's Board

This is a breast cancer treatment, Revtorpyk. It was approved by the FDA in July.

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, Sept. 30, 2026 (GLOBE NEWSWIRE) -- 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 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.

Celcuity Inc. (CELC) Presents at Citigroup's Biopharma Back to School Summit 2026 Prepared Remarks Transcript

MINNEAPOLIS, Sept. 01, 2026 (GLOBE NEWSWIRE) -- 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 Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences:

MINNEAPOLIS, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced the submission of its supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), locally advanced or metastatic breast cancer (“ABC”) with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy.

Celcuity Inc. remains a Buy as the REVTORPYK/gedatolisib FDA approval and rapid NCCN Category 1 inclusion de-risk clinical and commercial adoption. CELC's financials reflect a front-loaded commercial investment, with SG&A surging for launch, but a strengthened $754M cash position provides funding visibility into 2029. VIKTORIA-1 data show REVTORPYK delivers a step-change in efficacy and tolerability, supporting rapid physician adoption and a potential blockbuster franchise.

Celcuity Inc (NASDAQ:CELC) reported a narrower-than-expected loss for the second quarter on Thursday.