Immunome Inc. announced that the U.S. Food and Drug Administration has accepted its New Drug Application for varegacestat for the treatment of adults with desmoid tumors. The FDA assigned a Prescription Drug User Fee Act target action date of April 28, 2027. Varegacestat is an investigational, oral, once-daily gamma secretase inhibitor.

The acceptance marks a significant step for patients with desmoid tumors, a rare, non-metastatic soft tissue tumor that can cause debilitating pain and functional impairment. Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency by the end of 2026.

RINGSIDE Phase 3 Trial Results

The NDA is supported by data from the Phase 3 RINGSIDE trial, which evaluated varegacestat in patients with progressing desmoid tumors. The global, randomized, double-blind, placebo-controlled trial met its primary endpoint of progression-free survival.

Key findings from the trial include:

The trial demonstrated a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death compared to placebo. All key secondary endpoints were met, including objective response rate and change in tumor volume. Varegacestat also showed statistically significant improvement in worst pain intensity at week 12.

Safety Profile

Varegacestat was generally well tolerated with a manageable safety profile consistent with the gamma secretase inhibitor class. The most common adverse events in the treatment arm were diarrhea, fatigue, rash, nausea, and cough. The majority of events were grade 1 or 2.

The RINGSIDE trial randomized 156 patients to receive varegacestat 1.2 mg daily or placebo until disease progression or death. An open-label extension phase of the trial is ongoing.

Immunome, Inc. granted inducement awards consisting of non-statutory stock options to purchase an aggregate of 344,000 shares of common stock to 17 new employees on July 1, 2026. The Compensation Committee of the Company’s Board of Directors approved the grants as an employment inducement under Nasdaq Listing Rule 5635(c)(4). The awards were issued pursuant to the Company’s 2024 Inducement Plan.

Each stock option carries an exercise price of $21.49 per share, equal to the Company’s closing sales price on the grant date. The options will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date. The remaining 75% will vest monthly over the subsequent 36 months, contingent on the employee's continued service relationship with Immunome through the applicable vesting dates.

The stock options are subject to the terms and conditions of the 2024 Inducement Plan and the individual stock option agreements covering each grant. Immunome is a clinical-stage targeted oncology company focused on developing first-in-class and best-in-class targeted cancer therapies.

Key Details of the Grant

The Company’s pipeline includes varegacestat, an investigational gamma secretase inhibitor for which a New Drug Application (NDA) has been submitted to the U.S. FDA. Other assets include IM-1021, a clinical-stage ROR1 antibody-drug conjugate (ADC); IM-1617, a clinical-stage solid tumor ADC; and IM-3050, an IND-cleared FAP-targeted radiotherapy.