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Celcuity Inc.

Pipeline1 asset

  • gedatolisibPI3K/AKT/mTOR pathway; class I PI3K isoforms; mTORC1/2 / small molecule kinase inhibitor / Oncology
    HR+/HER2- advanced breast cancer, 2nd linePhase 3; NDA accepted/Priority Review for PIK3CA WTVIKTORIA-1 reported results; PDUFA July 17, 2026GlobalHR+/HER2- locally advanced or metastatic breast cancer, 1st linePhase 3VIKTORIA-2 ongoingNorth AmericaEuropeLatin AmericaAsiaMetastatic castration-resistant prostate cancerPhase 1/2CELC-G-201 ongoingUnited StatesEurope

Latest news13 items

All news

Celcuity To Participate in Upcoming Investor Conferences

MINNEAPOLIS, May 28, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced that Brian Sullivan, Chief Executive Officer and Co-founder of

Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients

Development of a gedatolisib formulation for subcutaneous injection is underway; first patent application submitted to the U.S. Patent and Trademark Office MINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development

Trial Design Update • Phase 3

Celcuity Announces Publication of Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Study of Gedatolisib Regimens in HR+/HER2- Advanced Breast Cancer in Journal of Clinical Oncology

As previously presented, gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and gedatolisib + fulvestrant (“gedatolisib doublet”) reduced the risk of disease progression or death versus fulvestrant by 76% and 67%, respectively MINNEAPOLIS, March 09, 2026 (GLOBE NEWSWIRE) -- Celcuity

Trial Results • Phase 3

Celcuity To Participate in Upcoming Investor Conferences

MINNEAPOLIS, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for

Celcuity Appoints Charles Romp to its Board of Directors

MINNEAPOLIS, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Charles (Chip) R. Romp to its Board of Directors. Mr.

Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial at the 2025 San Antonio Breast Cancer Symposium

For patients whose time to progression on immediate prior therapy was >18 months, median progression-free survival (“PFS”) was 12.4 months with gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and 10.0 months with gedatolisib + fulvestrant (“gedatolisib doublet”) versus 1.9 months

Presentation / Abstract • Phase 3
Celcuity Inc. • Endpoint Arena