NasdaqCM:IMNMBiotechs
Why Immunome (IMNM) Is Down 8.2% After FDA Accepts Varegacestat NDA With Strong Phase 3 Data
Immunome, Inc. previously announced that the FDA accepted its New Drug Application for varegacestat, an oral once-daily gamma secretase inhibitor for adults with desmoid tumors, assigning an April 28, 2027 PDUFA target action date based on the Phase 3 RINGSIDE trial.
The NDA rests on RINGSIDE data showing a statistically significant and clinically meaningful improvement in progression-free survival versus placebo, with a very large reduction in the risk of disease progression or...