StocksMedium•9 November 2026•
1 min read
FDA Accepts Celcuity sNDA for REVTORPYK to Treat Advanced Breast Cancer
Key Facts
1Celcuity announced that the FDA has accepted for review its supplemental New Drug Application (sNDA) for REVTORPYK for the treatment of specific advanced breast cancer patients.
2The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 25, 2027, for the decision.
Celcuity announced that the FDA has accepted for review its supplemental New Drug Application for REVTORPYK for the treatment of specific advanced breast cancer patients. GlobeNewswire reported that the FDA assigned a Prescription Drug User Fee Act goal date of June 25, 2027, for the regulatory decision.
The application targets locally advanced or metastatic breast cancer with a PIK3CA mutation following progression on or after at least one line of endocrine therapy. CELC closed at $66.79 on November 6, 2026, having traded between a low of $62.44 and a high of $67.27 during that session.