Celcuity Inc. (CELC) reported that its pivotal Phase 3 VIKTORIA-1 trial achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients with PIK3CA mutant HR+/HER2- advanced breast cancer treated with its investigational therapy gedatolisib in combination with fulvestrant and palbociclib.
The results address a major unmet need for patients whose disease progresses after CDK4/6 inhibitor and aromatase inhibitor therapy- an area where current treatment options offer only modest benefit.
Gedatolisib is a multi-target PAM inhibitor that blocks all four class I PI3K isoforms, mTORC1, and mTORC2- aiming to shut down the entire pathway and prevent adaptive resistance. Nonclinical and early clinical data show similar potency in both PIK3CA-mutant and wild-type tumor cells.
Trial OverviewThe VIKTORIA-1 study is a Phase 3, open-label, randomized trial evaluating gedatolisib plus fulvestrant with or without palbociclib in adults with HR+/HER2- advanced breast cancer whose disease progressed following CDK4/6 inhibitor therapy.The trial enrolled patients regardless of PIK3CA status, enabling separate analyses for mutant and wild-type cohorts.
In the PIK3CA-mutant cohort, patients were randomized to receive either:
- Gedatolisib triplet (gedatolisib + fulvestrant + palbociclib)
- Gedatolisib doublet (gedatolisib + fulvestrant)
- Comparator: alpelisib + fulvestrant
Primary and Secondary Endpoints Met
The gedatolisib triplet demonstrated a significant improvement in PFS compared to alpelisib plus fulvestrant, meeting the primary endpoint.
The gedatolisib doublet, evaluated as a key secondary endpoint, also showed a statistically significant and clinically meaningful PFS benefit versus alpelisib plus fulvestrant.
Both regimens were generally well tolerated, with no new safety signals reported.
Why These Resutls Matter
HR+/HER2- breast cancer accounts for about 70% of all breast cancers, and roughly 40% of these tumors carry PIK3CA mutations.
After progression on CDK4/6 inhibitors, treatment options are limited, and responses to therapies targeting only PI3Ka or AKT are often modest.
Gedatolisib is designed to comprehensively block the PI3K/AKT/mTOR, or PAM, pathway, targeting all major nodes simultaneously- an approach that may overcome resistance seen with single-target inhibitors.
Celcuity noted that these results, combined with previously reported data from the PIK3CA wild-type cohort, suggest gedatolisib has the potential to improve outcomes regardless of PIK3CA mutation status.
Regulatory Path Forward
The FDA has already granted Priority Review to Celcuity's NDA for gedatolisib in PIK3CA wild-type HR+/HER2- advanced breast cancer, with a PDUFA date of July 17, 2026.
Celcuity plans to submit a supplemental NDA for the PIK3CA-mutant indication based on the new VIKTORIA-1 data.
Detailed results will be presented in a late-breaking oral session at the 2026 ASCO Annual Meeting.
CELC has traded between $9.51 and $129.09 over the past year. The stock closed Friday's trading (May 1, 2026) at $125.65, up 3.54%. In pre-market trading, the stock is at $155.04, up 23.39%.
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