FDA accepts Immunome's varegacestat NDA for desmoid tumors, with an April 28, 2027, PDUFA date backed by positive Phase 3 data.
Immunome Inc.
(NASDAQ:IMNM) said the U.S.
Food and Drug Administration (FDA) has accepted its New Drug Application for varegacestat, an investigational oral, once-daily gamma secretase inhibitor, for the treatment of adults with desmoid tumors.
The agency assigned a Prescription Drug User Fee Act target action date of April 28, 2027.
The NDA is supported by data from the Phase 3 RINGSIDE trial, which evaluated varegacestat in patients with progressing desmoid tumors.
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