Celcuity’s Phase 3 Trial Shows PFS Gains, FDA Sets July 17 PDUFA
Celcuity’s Phase 3 VIKTORIA-1 trial met its primary endpoint, showing statistically significant progression-free survival improvement with gedatolisib plus fulvestrant (with/without palbociclib) versus alpelisib regimens in PIK3CA-mutant HR+/HER2- advanced breast cancer. The FDA accepted its NDA for wild-type patients with a PDUFA date of July 17, 2026, while net loss widened to $52.8 million in Q1.
1. Clinical trial results
Celcuity reported that both gedatolisib regimens in the Phase 3 VIKTORIA-1 trial demonstrated statistically significant and clinically meaningful progression-free survival improvements versus alpelisib plus fulvestrant in PIK3CA-mutant HR+/HER2- advanced breast cancer, with manageable safety profiles and no new signals. Detailed triplet and doublet data will be showcased at the ASCO Annual Meeting on June 2, 2026, ahead of a supplemental NDA submission in Q3.
2. VIKTORIA-2 trial expansion
The Phase 3 VIKTORIA-2 program now comprises two independent studies: Study 1 in approximately 440 endocrine-resistant HR+/HER2- patients evaluating gedatolisib with fulvestrant and palbociclib, and Study 2 in about 740 treatment-naive endocrine-sensitive patients assessing gedatolisib with letrozole and palbociclib. This expansion targets nearly all first-line HR+/HER2- advanced breast cancer cases, regardless of PIK3CA or endocrine status.
3. Regulatory milestones
In January 2026, the FDA accepted Celcuity’s NDA for gedatolisib in PIK3CA wild-type HR+/HER2- advanced breast cancer and granted Priority Review with a PDUFA goal date of July 17, 2026. Celcuity also submitted its first patent application for a subcutaneous gedatolisib formulation to enable injection delivery and support future long-duration treatment indications.
4. Q1 financial results
For the quarter ended March 31, 2026, Celcuity reported a GAAP net loss of $52.8 million ($0.97 per share), up from $37.0 million ($0.86 per share) in Q1 2025, and a non-GAAP adjusted net loss of $46.8 million ($0.86 per share), compared to $34.7 million ($0.81 per share) a year earlier. Total operating expenses rose to $50.5 million from $36.1 million, driven by increased R&D spending.