Celcuity surges as Phase 3 VIKTORIA-1 breast-cancer trial hits primary endpoint
CELC•Celcuity shares jumped on May 4, 2026 after the company disclosed positive top-line Phase 3 VIKTORIA-1 results for gedatolisib in the PIK3CA-mutant HR+/HER2- advanced breast cancer cohort. The trial met its primary endpoint with a statistically significant progression-free survival benefit, and the company plans an FDA supplemental NDA submission.
1) What’s moving the stock
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.
2) The key clinical takeaways
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.
3) What happens next (FDA, ASCO, and timelines)
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.
