Immunome posts Q3 2026 update with varegacestat PDUFA date and new ADC trial clearance

Immunome, Inc. reported financial results and a business update for the quarter ended September 30, 2026, on November 9, 2026.

The company's lead program, varegacestat, carries a PDUFA target action date of April 28, 2027, following FDA acceptance of the NDA in July 2026¹. In Europe, the EMA validated Immunome's MAA for varegacestat for treatment of adults with desmoid tumors in October 2026¹. Additional Phase 3 data from the RINGSIDE trial, including patient-reported outcomes, were shown at the 2026 ESMO Congress, presented across three posters and a rapid oral session¹.

For IM-1021, a ROR1-targeted ADC, the Phase 1 trial is ongoing and Immunome expects to present an updated dataset at the ASH Annual Meeting on December 14, 2026¹. As of a June 26, 2026 data cutoff, the objective response rate among 11 response-evaluable DLBCL patients was 64% (7/11), including three complete responses, and across all 19 response-evaluable B-NHL patients the rate was 53% (10/19), with five complete responses¹. Safety data showed treatment-emergent adverse events in 92% of 25 treated B-NHL patients, with Grade 3 or higher TEAEs in 52%, most commonly neutropenia at 44%¹.

On the solid tumor ADC side, the first patient was dosed in June 2026 in a Phase 1 trial of IM-1617, directed at an undisclosed target and using the HC74 TOP1 inhibitor payload¹. Separately, Immunome received IND clearance for IM-1340 in September 2026 and plans to start a Phase 1 trial by year-end¹. A third program, IM-3050, began dosing its first patient in July 2026 in a Phase 1 trial for FAP-expressing advanced solid tumors¹. Preclinically, Immunome expects to submit an IND for IM-1335 in late 2026¹.

On finances, cash, cash equivalents and marketable securities totaled $461.6 million as of September 30, 2026, which the company said funds operations into 2028¹. Immunome reported a net loss of $85.8 million for the quarter¹.