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Celcuity says FDA approves REVTORPYK for HR+/HER2- PIK3CA wild-type metastatic breast cancer

PUBT·07/14/2026 20:53:49
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Celcuity says FDA approves REVTORPYK for HR+/HER2- PIK3CA wild-type metastatic breast cancer
  • Celcuity won FDA clearance for REVTORPYK (gedatolisib) in HR+/HER2- metastatic breast cancer with PIK3CA wild-type disease.
  • Label covers patients whose cancer progressed on or after at least one line of endocrine therapy in the metastatic setting.
  • VIKTORIA-1 showed PFS of 9.3 months with REVTORPYK, palbociclib, fulvestrant vs 2.0 months with fulvestrant alone.
  • Commercial launch targeted for late Q3 2026; expanded access program planned ahead of launch.


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: 202607141653PRIMZONEFULLFEED9762252) on July 14, 2026, and is solely responsible for the information contained therein.