Shares of Immunome (IMNM +15.51%) jumped over 15% on Monday after the biotech company announced positive clinical results for varegacestat, an investigational treatment for patients with progressing desmoid tumors.
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A destructive disease
Desmoid tumors can be debilitating and lead to life-threatening organ damage. Each year, 1,000 to 1,650 people are diagnosed with the health condition in the U.S. alone.
"Desmoid tumors can have a devastating physical and emotional impact on patients given their unpredictable nature and the limitations of current treatment options," Dr. Mrinal Gounder, the trial's primary investigator, said in a press release.
Varegacestat could become the standard of care
The phase 3 clinical trial met its primary endpoint of improving progression-free survival, with an 84% reduction in the risk of disease progression or death compared to placebo. The trial also met all key secondary endpoints, including reductions in tumor volume and pain intensity.
Importantly, Varegacestat was generally well tolerated. Common side effects reported by trial participants included diarrhea, fatigue, rash, nausea, and cough.
NASDAQ: IMNM
Key Data Points
Based on the study's promising results, Immunome intends to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026.
"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," CEO Clay Siegall said.
