Celcuity's gedatolisib trial cuts death risk but misses investor expectations

Celcuity reported data from its Phase 3 VIKTORIA-1 trial evaluating gedatolisib in HR‑positive, HER2‑negative breast cancer with PIK3CA mutations.

The trial enrolled 350 patients who had progressed after prior therapy and compared a triplet regimen (gedatolisib + hormone therapy + Pfizer’s Ibrance) with a doublet (gedatolisib + hormone therapy) and a control arm.

Both experimental arms roughly halved the risk of death or disease progression, showing a clear efficacy signal, but the magnitude fell short of Wall Street forecasts, causing Celcuity’s share price to drop more than 20%.

Investors had hoped the data would establish a new standard of care, but the disappointment underscores the challenge of translating promising biomarker‑driven results into market‑moving approvals.