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FDA accepts Immunome NDA for desmoid tumor drug varegacestat, sets April 28, 2027 PDUFA date

PUBT·07/08/2026 11:31:20
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FDA accepts Immunome NDA for desmoid tumor drug varegacestat, sets April 28, 2027 PDUFA date
  • Immunome secured FDA acceptance of its NDA for varegacestat to treat adults with desmoid tumors.
  • PDUFA target action date set for April 28, 2027.
  • Filing backed by Phase 3 RINGSIDE data showing an 84% cut in progression or death risk vs placebo (HR 0.16).


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. Immunome Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260708283482) on July 08, 2026, and is solely responsible for the information contained therein.