Gedatolisib Combination Treatment for Advanced Hormone

Gedatolisib Combination Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
83%48%14%Apr 21Apr 22Apr 23Apr 24Apr 25Apr 26Apr 27Apr 28Apr 29Apr 30May 1May 2May 3May 4May 5May 6May 7May 8May 9May 10May 11May 12May 13May 14May 15May 16May 17May 18May 19May 20May 21May 22May 23May 24May 25May 21 • YES 24.9%May 22 • YES 28.9%May 23 • YES 65.9%May 24 • YES 70.9%May 25 • YES 71.5%
Celcuity Inc ($CELC)
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CELC

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 3Matched gedatolisib, hormone, receptor-positive, her2-negative, breast
CELC

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 3Matched gedatolisib, hormone, breast, plus, fulvestrant
CELC

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 3Matched gedatolisib, hormone, her2-negative, breast, plus
CELC

Celcuity's Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort

Detailed data for the gedatolisib triplet and doublet regimens will be presented at a late-breaking abstract oral session at the 2026 ASCO Annual Meeting MINNEAPOLIS, May 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of

Trial Results • Phase 3Matched gedatolisib, hormone, breast, plus, fulvestrant
CELC

Celcuity Inc. Reports Release of First Quarter 2026 Financial Results and Provides Corporate Update

Phase 3 VIKTORIA-1 trial achieved primary endpoint with clinically meaningful improvement in progression-free survival in PIK3CA mutant cohort; detailed data for gedatolisib regimens will be presented at the 2026 ASCO Annual Meeting Phase 3 VIKTORIA-2 trial expanded to include a second study

Trial Results • Phase 3Results event Thu, May 14, 2026, 4:30 PM EDTMatched gedatolisib, hormone, breast, plus, fulvestrant