Celcuity files sNDA for REVTORPYK in PIK3CA-mutant advanced breast cancer

Celcuity Inc.

sNDA seeks FDA approval for REVTORPYK (gedatolisib) in HR+/HER2- ABC with PIK3CA mutation after ≥1 endocrine therapy.
Phase 3 VIKTORIA-1: triplet cut progression/death risk by 50% vs alpelisib+fulvestrant (HR=0.50, p<0.0001); median PFS 11.1 vs 5.6 months.
Doublet: HR=0.51 (p=0.0013), median PFS 11.3 vs 5.6 months; ORR 49% (triplet) and 36% (doublet).
If approved, first therapy for PIK3CA-mutant ABC inhibiting all class I PI3K isoforms and mTORC1/C2.
FDA approved REVTORPYK for PIK3CA wild-type ABC on July 14, 2026; this submission expands to mutant population.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.