Immunome, Inc. (NASDAQ:IMNM) shares are trading higher on Monday after the company announced results from the global pivotal Phase 3 RINGSIDE trial of varegcasetat and the company met its primary endpoint.
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What To Know: Immunome announced positive topline results from its global pivotal Phase 3 RINGSIDE trial evaluating varegacestat, an investigational oral, once-daily gamma secretase inhibitor, in patients with progressing desmoid tumors.
The registrational trial met its primary endpoint, with varegacestat significantly improving progression-free survival compared with placebo. The company reported an 84% reduction in the risk of disease progression or death, with a hazard ratio of 0.16 and a p-value of less than 0.0001.
The trial also met all key secondary endpoints.
Immunome said varegacestat achieved a confirmed objective response rate of 56%, compared with 9% for placebo, as assessed by blinded independent central review. In an exploratory analysis, varegacestat showed a median best change in tumor volume of negative 83%, versus positive 11% for placebo. The treatment also demonstrated statistically significant improvements in landmark tumor volume reduction and worst pain intensity.
Immunome said varegacestat was generally well tolerated, with a manageable safety profile consistent with the gamma secretase inhibitor class. The most common adverse events included diarrhea, fatigue, rash, nausea and cough, with most events reported as grade one or two.
Based on the trial results, Immunome plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second quarter of 2026.
IMNM Price Action: At the time of writing, Immunome shares closed Monday 15.69% higher at $22.64, according to data from Benzinga Pro.
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