FDA accepts Celcuity sNDA for REVTORPYK with PDUFA target of June 2027
Celcuity Inc. announced that the U.S. Food and Drug Administration has taken its supplemental New Drug Application for REVTORPYK (gedatolisib) into review. The filing seeks to add a label for hormone‑receptor‑positive, HER2‑negative breast cancer that carries a PIK3CA mutation. The agency set a PDUFA target of June 25 2027 for its decision. The company highlighted Phase 3 VIKTORIA‑1 data supporting the request.
Why it matters
The acceptance moves the drug closer to a potential second‑line indication for a sizable patient subgroup, which could increase Celcuity’s sales if approved. The PDUFA target gives investors a clear timeline for a decision that may affect the stock price.
Key facts
- 1The FDA accepted Celcuity’s supplemental New Drug Application for REVTORPYK to treat HR+/HER2‑negative, PIK3CA‑mutated advanced breast cancer. investing.com
- 2The agency set a PDUFA target of June 25 2027 for its review. rttnews.com
- 3The sNDA is based on data from the PIK3CA‑mutant cohort of the Phase 3 VIKTORIA‑1 trial. investing.com
- 4Celcuity’s CEO Brian Sullivan said the acceptance represents progress toward broader patient access. rttnews.com
- 5Celcuity’s stock rose 5.17% to $70.24 following the announcement. rttnews.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.