Celcuity (CELC) is rallying on May 4, 2026 as investors react to newly released positive top-line results from the Phase 3 VIKTORIA-1 study in patients with HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA mutations. The company said the gedatolisib regimen achieved a statistically significant and clinically meaningful improvement in progression-free survival, driving a sharp re-pricing of the program’s commercial odds and potential market size.

In the PIK3CA-mutant cohort, Celcuity reported that gedatolisib combined with fulvestrant and palbociclib (the “triplet”) improved progression-free survival versus a standard-of-care comparator regimen. The company also said a secondary endpoint comparing a gedatolisib plus fulvestrant “doublet” versus a comparator regimen demonstrated a statistically significant and clinically meaningful progression-free survival improvement, and that both regimens were generally well tolerated with manageable safety and no new safety signals.

Celcuity plans to submit the VIKTORIA-1 PIK3CA-mutant data to the FDA as a supplemental New Drug Application (sNDA), a key step toward expanding any eventual U.S. label into an additional biomarker-defined segment of HR+/HER2- advanced breast cancer. The company said detailed data for the gedatolisib triplet and doublet regimens are scheduled for a late-breaking abstract oral presentation at the 2026 ASCO Annual Meeting (May 29–June 2, 2026, Chicago), with the specific oral session listed for June 2, 2026.