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News
- Celcuity submitted a supplemental NDA to the FDA for REVTORPYK (gedatolisib) in PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancerAug 26, 2026
- FDA-approved REVTORPYK was added to NCCN clinical practice guidelines for HR+/HER2- locally advanced or metastatic breast cancerJul 31, 2026
- FDA approved REVTORPYK for HR-positive, HER2-negative, PIK3CA wild-type advanced or metastatic breast cancerJul 15, 2026
- Celcuity expanded the Phase 3 VIKTORIA-2 trial of Gedatolisib to include endocrine-sensitive HR+/HER2- breast cancer patientsMay 14, 2026
- Celcuity reported its Phase 3 VIKTORIA-1 trial met the primary endpoint with improved progression-free survivalMay 4, 2026