Immunome Inc. (NASDAQ:IMNM) stock rose Monday, with session volume surging to 8.25 million shares, well above the stock’s average daily volume of 1.50 million, according to Benzinga Pro data.
Immunome on Monday shared topline results from the global pivotal Phase 3 RINGSIDE trial of varegacestat for progressing desmoid tumors.
A desmoid tumor, also known as aggressive fibromatosis, is a rare, noncancerous growth in connective tissue, often in the abdomen, arms, or legs, that is locally aggressive (infiltrates surrounding tissue) but doesn’t spread (metastasize).
Primary Endpoint Results
The trial met its primary endpoint of improving progression-free survival, demonstrating a statistically significant and clinically meaningful improvement versus placebo, with an 84% reduction in the risk of disease progression or death.
The confirmed objective response rate (ORR) was 56% with varegacestat versus 9% with placebo.
In an exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% versus +11% with placebo.
Secondary Endpoints And Pain Reduction
In addition, the trial met all key secondary endpoints, with varegacestat achieving statistically significant improvements versus placebo in landmark tumor volume reduction and worst pain intensity.
Varegacestat was generally well-tolerated, with a manageable safety profile.
Immunome plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second quarter of 2026.
Management Commentary
“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 were up 20.87% at $23.65 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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