Celcuity Inc. announced the full enrollment of the PIK3CA mutant cohort in its Phase 3 VIKTORIA-1 clinical trial.

Celcuity shares surged 34% in premarket trading.

The study is evaluating gedatolisib plus fulvestrant, with and without palbociclib, compared to alpelisib and fulvestrant in adults with hormone receptor-positive, HER2-negative, PIK3CA-mutant advanced or metastatic breast cancer who have progressed following treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

The company expects to report topline data for this cohort in late Q1 or Q2 of 2026. Additionally, Celcuity released updated analysis from a Phase 1b clinical trial. In this trial, patients with HR+/HER2-/PIK3CA-mutated advanced breast cancer treated with gedatolisib combined with fulvestrant and palbociclib had a median progression-free survival of 14.6 months. The results from the Phase 1b trial have already been presented, while results from the Phase 3 cohort will be reported in the future.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9547771-en) on October 18, 2025, and is solely responsible for the information contained therein.