Varegacestat Phase 3 PRO Data Show Symptom, Function Gains in Desmoid Tumors
IMNM sits 24% above its 52-week low of $14.64.
Summary
Immunome presented additional Phase 3 RINGSIDE data at ESMO 2026 showing varegacestat improved patient-reported symptom and physical function scores versus placebo in desmoid tumors. The TSS-5 symptom score fell 1.50 points versus a 0.59-point worsening on placebo at week 48, and PROMIS physical function rose 3.90 versus a 3.04 decline. These reinforce the efficacy already seen in the trial: ORR of 56% versus 9% (p<0.0001) and a PFS hazard ratio of 0.16. The FDA has accepted the NDA with a PDUFA date of April 28, 2027, so the PRO and functional data matter mainly for labeling and payer discussions rather than the approval decision itself. This follows the Q2 disclosure that the NDA was accepted and the October 8-K in which Immunome paid BMS $20 million cash plus 4.4 million shares to clear future milestone and royalty obligations on the program.
At the time of this announcement, IMNM was trading at $18.11 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.1B. The 52-week trading range was $14.64 to $30.06. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.