CELC · Celcuity Inc.

Celcuity Inc. reported positive topline results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 trial evaluating gedatolisib plus fulvestrant with or without palbociclib in HR+/HER2- advanced breast cancer patients who progressed on prior CDK4/6 inhibitor and aromatase inhibitor therapy. The primary efficacy analysis of the gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to alpelisib plus fulvestrant. The secondary endpoint comparing the gedatolisib doublet (gedatolisib + fulvestrant) versus alpelisib plus fulvestrant also showed statistically significant PFS improvement. Both regimens were generally well tolerated with manageable safety profiles and no new safety signals. These results are particularly notable as they represent the first Phase 3 study to show that comprehensive blockade of the PI3K/AKT/mTOR (PAM) pathway can significantly improve outcomes versus single-target PI3Kα inhibition in PIK3CA-mutant patients. Celcuity intends to submit these data as a supplemental New Drug Application (sNDA) to the FDA and to present detailed results at the 2026 ASCO Annual Meeting (late-breaking abstract LBA1008). The company also has an ongoing NDA for gedatolisib in PIK3CA wild-type ABC under Priority Review with a PDUFA date of July 17, 2026. These positive results expand the potential addressable patient population for gedatolisib and strengthen its competitive position in the HR+/HER2- advanced breast cancer treatment landscape.