Celcuity Inc. — Form 8-K
Filed August 26, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 72/100
What the filing says
Celcuity submitted a supplemental New Drug Application (sNDA) to the FDA on August 26, 2026, for REVTORPYK (gedatolisib) to treat HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA mutations. The application is supported by Phase 3 VIKTORIA-1 trial data from 350 PIK3CA-mutant subjects, showing REVTORPYK-triplet reduced disease progression/death risk by 50% (HR=0.50; median PFS 11.1 months vs. 5.6 months) and REVTORPYK-doublet by 49% (HR=0.51; median PFS 11.3 months) versus alpelisib plus fulvestrant. REVTORPYK was previously approved July 14, 2026, for PIK3CA wild-type patients; this sNDA expands addressable market to ~40% of HR+/HER2- patients with PIK3CA mutations.
Why this rating
sNDA for label expansion of approved drug addressing ~40% more HR+/HER2- patients; strong trial efficacy (50% risk reduction) supports approval likelihood; meaningfully expands commercial opportunity relative to $457.5M market cap.
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