Immunome Says FDA Accepted NDA for Desmoid Tumors Drug

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%