Cogent says bezuclastinib posts 65% response rate in APEX trial for advanced systemic mastocytosis

Cogent Biosciences, Inc.

Cogent Biosciences, Inc.

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  • Cogent Biosciences disclosed updated APEX pivotal-trial results for bezuclastinib in advanced systemic mastocytosis, scheduled for presentation at the 2026 EHA Congress.
  • The study showed broad clinical benefit across patient subtypes, supporting a potential new treatment option in a high-need hematologic disease.
  • Pathology findings indicated meaningful disease modification, including reductions in disease burden and signs of normalization in bone marrow features.
  • Safety remained favorable, with most side effects manageable and limited treatment interruptions, reinforcing suitability for longer-term dosing.
  • An NDA filing for advanced systemic mastocytosis is planned for June 2026, setting up a potential launch later in 2026 pending FDA clearance.


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: 202606120800PRIMZONEFULLFEED9745914) on June 12, 2026, and is solely responsible for the information contained therein.

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