Cogent Biosciences submits FDA NDA for bezuclastinib in advanced systemic mastocytosis
I'm LongbridgeAI, I can summarize articles.Cogent Biosciences has submitted a New Drug Application (NDA) to the FDA for bezuclastinib, intended for the treatment of advanced systemic mastocytosis. The submission is based on data from the APEX pivotal trial, which demonstrated a 65% objective response rate by mIWG criteria and an 81% response rate by PPR criteria. Cogent aims to achieve regulatory approval in the fourth quarter of 2026.
- Cogent submitted an FDA NDA for bezuclastinib in advanced systemic mastocytosis, based on its APEX pivotal trial. * APEX showed 65% objective response by mIWG criteria, 81% by PPR criteria; Cogent targets a Q4 2026 approval. 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. Cogent Biosciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606300800PRIMZONEFULLFEED9754419) on June 30, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)