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

The FDA has granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2-/ PIK3CA wild-type (“WT”) ABC and assigned a Prescription Drug User Fee Act ...
Seeking Alpha

Detailed Results from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing ...

MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced detailed efficacy ...
Medscape

Low-Dose Aspirin Cuts CRC Recurrence

Low-dose aspirin reduced colorectal cancer (CRC) recurrence rates by more than half in patients with tumors harboring mutations in the PI3K signaling pathway, according to findings from the phase 3 ...
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Celcuity Inc. (CELC) Discusses Additional Results From Phase III VIKTORIA-1 Trial and Insights Into PAM Pathway Targeting Transcript

Hello, and thank you for standing by. My name is Bella, and I will be your conference operator today. At this time, I would like to welcome everyone to Phase III VIKTORIA-1 Additional Results ...
The American Journal of Managed Care

Low-Dose Aspirin Cuts Recurrence Risk in PI3K-Altered Colorectal Cancer

Low-dose aspirin significantly reduced colorectal cancer recurrence in patients with PI3K pathway gene alterations, nearly halving recurrence rates over three years compared to placebo. The study ...
EurekAlert!

New advances in targeted therapies for PIK3CA-mutated cancers

PI3K signaling pathways. Upon activation by RTK, GPCR, Integrin, and Ras, p110 loses inhibition by p85 and converts PIP2 to PIP3. PIP3 recruits AKT to the cell membrane, where AKT is activated through ...