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Immunome Says FDA Accepted NDA for Desmoid Tumors Drug

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Immunome (IMNM) said Wednesday that the US Food and Drug Administration has accepted its new drug application for varegacestat, intended to treat adults with desmoid tumors.

The agency assigned a Prescription Drug User Fee Act target action date of April 28, 2027, the company said.

The company said its application was based on a phase-3 trial, which met its primary endpoint of improving progression-free survival compared with a placebo. The trial also met key secondary endpoints, it said.

Shares of the company were down more than 5% in Wednesday's premarket activity.

Price: $23.08, Change: $-1.31, Percent Change: -5.36%

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