Immunome, Inc. (IMNM) shares rallied Monday after the biotech company delivered what can only be described as knockout results from its Phase 3 trial. If you're wondering why the stock popped over 15%, here's the story.
What Happened: 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 numbers? Pretty spectacular. 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. In clinical trial speak, that's about as definitive as it gets.
But wait, there's more. The trial also met all key secondary endpoints. Varegacestat achieved a confirmed objective response rate of 56%, compared with just 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. Translation: tumors shrank dramatically on the drug while actually growing slightly on placebo.
The treatment also demonstrated statistically significant improvements in landmark tumor volume reduction and worst pain intensity, which matters enormously for patients dealing with these tumors.
Safety Profile: 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.
What's Next: 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.