Immunome reports Q2 2026 results, varegacestat NDA under FDA review
Immunome said the FDA accepted its NDA for varegacestat in desmoid tumors with an April 28, 2027 PDUFA date, while two more programs began dosing patients.
Immunome announced financial results for the quarter ended June 30, 2026, alongside a business update on August 11, 2026. In July 2026, the U.S. FDA accepted Immunome's NDA for varegacestat for the treatment of adults with desmoid tumors and assigned a PDUFA target action date of April 28, 2027.1 The company plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.1
Detailed data from the Phase 3 RINGSIDE trial were presented at the 2026 ASCO Annual Meeting. The trial met its primary endpoint, with varegacestat showing an 84% reduction in the risk of disease progression or death versus placebo (hazard ratio = 0.16, p<0.0001). Progression-free survival benefit was consistent across prespecified subgroups. The trial also met all key secondary endpoints, including a confirmed objective response rate of 56% versus 9% with placebo (p<0.0001) by blinded independent central review, and showed statistically significant improvement in worst pain intensity at week 12.1
Three other clinical-stage programs are enrolling. The Phase 1 trial of IM-1021 is ongoing, with objective responses observed in participants with B-cell lymphoma at multiple dose levels, and initial lymphoma data are expected in 2026.1 In June 2026, the first patient was dosed in a Phase 1 first-in-human trial of IM-1617 in advanced solid tumors, including colorectal cancer, non-small cell lung cancer and breast cancer.1 In July 2026, the first patient was dosed in a Phase 1 first-in-human trial of IM-3050, a FAP-targeted radioligand therapy, designed to evaluate safety, dosimetry, pharmacokinetics and preliminary anti-tumor activity.1 Immunome expects to submit INDs for IM-1340 and IM-1335 in mid- and late 2026, respectively.1
On finances, as of June 30, 2026, cash, cash equivalents and marketable securities totaled $520.0 million, and Immunome said this is expected to fund operations into 2028.1 The company reported a net loss of $73.1 million for the quarter.1
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