# FDA Approves Celcuity Revtorpyk (gedatolisib) for HR+/HER2- PIK3CA Wild-Type Advanced Breast Cancer

> fda · REPORTED · 2026-08-13

The FDA approved Revtorpyk (gedatolisib) on July 14, 2026 for hormone receptor-positive, HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer, making it the first treatment specifically indicated for this population representing roughly 60% of second-line HR+ breast cancer cases. Celcuity also completed a $575 million convertible note offering and announced its Phase 3 VIKTORIA-1 trial met its primary endpoint in the PIK3CA mutant cohort.

About Celcuity Inc.: Celcuity is a biotechnology company developing and commercializing targeted PI3K/AKT/mTOR pathway therapies for solid tumor oncology indications, with gedatolisib as its lead commercial asset.

- Company: Celcuity Inc.
- Sector: oncology
- Primary source: https://www.sec.gov/Archives/edgar/data/0001603454/000119312526349227/celc-ex99_1.htm

---
Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.