Celcuity Inc. Files sNDA to FDA for REVTORPYK in HR+/HER2- Breast Cancer

What Happened
On August 26, 2026, Celcuity Inc. (CELC) announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for REVTORPYK™ (gedatolisib). The submission seeks approval for the treatment of patients with hormone receptor‑positive (HR+), HER2‑negative (HER2‑) locally advanced or metastatic breast cancer (ABC) who have a PIK3CA mutation and whose disease progressed on or after at least one line of endocrine therapy. The company disclosed the submission in a press release furnished with the Form 8‑K.

Key Details

• Date of disclosure: August 26, 2026.
• Product: REVTORPYK™ (gedatolisib), sNDA submitted to the FDA.
• Target population: HR+/HER2‑ locally advanced or metastatic breast cancer with a PIK3CA mutation, following progression on/after ≥1 line of endocrine therapy.
• Announcement format: Press release included with the Form 8‑K (Exhibit 99.1).

Why It Matters
This filing is a regulatory milestone that could lead to label expansion and potential commercial revenue if the FDA accepts and ultimately approves the sNDA. For investors, the submission advances Celcuity’s clinical and regulatory progress for a biomarker‑defined patient population (PIK3CA mutation), which may increase the value of the company’s pipeline if further milestones (FDA acceptance, review decisions) follow. Note this is a submission, not an approval; investors should watch for subsequent FDA actions and company updates.