Immunome Inc. (IMNM) stock surged Monday, with trading volume exploding to 8.25 million shares compared to its typical 1.50 million daily average. The reason? Some genuinely impressive clinical trial results that suggest the biotech might have a winner on its hands.
The company released topline data from its global Phase 3 RINGSIDE trial testing varegacestat in patients with progressing desmoid tumors. If you're not familiar with desmoid tumors, here's the quick version: they're rare, noncancerous growths in connective tissue that typically appear in the abdomen, arms, or legs. While they don't metastasize like cancer, they're locally aggressive and infiltrate surrounding tissue, earning them the alternate name "aggressive fibromatosis."
The Numbers That Matter
The trial crushed its primary endpoint of improving progression-free survival. We're talking about an 84% reduction in the risk of disease progression or death compared to placebo. That's a statistically significant and clinically meaningful result by any measure.
The confirmed objective response rate tells an equally compelling story: 56% with varegacestat versus 9% with placebo. And in an exploratory analysis, varegacestat showed a median best change in tumor volume of -83% compared to +11% growth with placebo. Yes, tumors actually grew in the placebo group while shrinking dramatically in the treatment group.
Beyond the Primary Results
The trial also met all key secondary endpoints, with varegacestat delivering statistically significant improvements in landmark tumor volume reduction and worst pain intensity versus placebo. That pain reduction matters enormously for quality of life in this patient population.
Importantly, varegacestat was generally well-tolerated with a manageable safety profile. The drug is a once-daily oral medication, which beats the alternatives for patient convenience.
Immunome plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second quarter of 2026.
What Management Is Saying
"RINGSIDE is the largest and most comprehensive clinical trial conducted to date in patients with desmoid tumors, and the topline results represent the highest objective response rate observed in a randomized clinical trial in this patient population," said Immunome's CEO, Clay Siegall, Ph.D. "These findings demonstrate the potential of varegacestat to offer best-in-class results in a convenient, once-daily, oral medicine that may help patients reclaim their lives."
IMNM Price Action: Immunome shares jumped 20.87% to $23.65 at the time of publication on Monday, hitting a new 52-week high.