Phase 3 VIKTORIA-1 data: gedatolisib triplet reduces progression risk by 76% in HR+/HER2- ABC

Celcuity Inc.

Median PFS 9.3mo for gedatolisib triplet vs 2.0mo for fulvestrant (HR=0.24); incremental 7.3mo improvement.
ORR 31.5% for triplet vs 1% for fulvestrant; median DOR 17.5mo.
Rolling NDA submission started under FDA RTOR; completion targeted Q4 2025.
PIK3CA mutant cohort fully enrolled; topline expected late Q1 2026 or Q2 2026.
Phase 1b data: median PFS 14.6mo in PIK3CA mutant patients overall, 19.7mo with intermittent dose.

item 7.01item 8.01item 9.01

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.