-+ 0.00%
-+ 0.00%
-+ 0.00%

Celcuity submits FDA sNDA for REVTORPYK in PIK3CA-mutant advanced breast cancer

PUBT·08/26/2026 12:31:41
Listen to the news
Celcuity submits FDA sNDA for REVTORPYK in PIK3CA-mutant advanced breast cancer
  • Celcuity filed a supplemental NDA with the FDA for REVTORPYK (gedatolisib) in HR+/HER2- advanced breast cancer with PIK3CA mutations.
  • Submission targets patients whose disease progressed on or after at least one line of endocrine therapy.
  • VIKTORIA-1 data showed PFS of 11.1 months with the triplet vs 5.6 months for alpelisib-fulvestrant; HR 0.5.
  • REVTORPYK won FDA clearance on July 14, 2026 for the same setting in PIK3CA wild-type disease.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Celcuity Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608260830PRIMZONEFULLFEED9816232) on August 26, 2026, and is solely responsible for the information contained therein.