# FDA Approves Celcuity REVTORPYK for PIK3CA Wild-Type HR+/HER2- Metastatic Breast Cancer

> fda · REPORTED · 2026-08-13

The FDA approved REVTORPYK (gedatolisib) on July 14, 2026 for HR+/HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer after prior endocrine therapy, and it was added to NCCN Guidelines as a preferred Category 1 second-line option. Celcuity reported these milestones alongside Q2 2026 financials in an 8-K filed August 13, 2026, with commercial shipments expected late Q3 2026.

About Celcuity: Celcuity is a clinical-stage biopharmaceutical company developing targeted therapies for breast cancer driven by dysregulated cellular signaling pathways, with REVTORPYK as its first commercial product.

- Company: Celcuity
- Sector: oncology
- Primary source: https://www.stocktitan.net/sec-filings/CELC/8-k-celcuity-inc-reports-material-event-15bb11459638.html

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