Immunome, Inc.

Immunome Announces EMA Validation of Marketing Authorization Application for Varegacestat for the Treatment of Adults with Desmoid Tumors

The EMA has validated Immunome's Marketing Authorization Application for varegacestat, an oral once-daily gamma secretase inhibitor for adults with desmoid tumors, initiating centralized review in the EU. The application rests on the Phase 3 RINGSIDE trial, which met its primary endpoint with an 84% reduction in risk of progression or death (HR 0.16, p<0.0001) and an objective response rate of 56% vs 9% for placebo. The FDA previously accepted the NDA with a PDUFA target action date of April 28, 2027, making regulatory decisions on both sides of the Atlantic the key upcoming catalysts.

•2d ago

Immunome Presents Additional Clinical Data for Varegacestat in Desmoid Tumors at ESMO 2026

Immunome presented additional Phase 3 RINGSIDE data for varegacestat in progressing desmoid tumors at ESMO 2026, including a rapid oral presentation on patient-reported outcomes. At week 48, varegacestat improved symptom burden (GODDESS TSS-5 least-squares mean change of -1.50 vs +0.59 for placebo) and physical function (PROMIS +3.90 vs -3.04), building on the previously reported positive primary and key secondary endpoints. The NDA was accepted by the FDA in July 2026 with a PDUFA date of April 28, 2027, and a European Marketing Authorization Application is planned by end of 2026.

•6d ago

Immunome Announces IND Clearance for IM-1340, a Potential First-in-Class Antibody-Drug Conjugate for the Treatment of Solid Tumors

The FDA cleared Immunome's IND for IM-1340, a potential first-in-class antibody-drug conjugate targeting a transport receptor expressed across solid tumors. IM-1340 uses Immunome's proprietary HC74 topoisomerase I inhibitor payload, and preclinical studies showed tumor regressions after a single dose in multiple in vivo models. The company expects to start a Phase 1 first-in-human dose-escalation and expansion trial in advanced solid tumors in Q4 2026, making IM-1340 its fifth clinical program.

•1mo ago

Immunome Reports Second Quarter 2026 Financial Results and Provides Business Update

Immunome announced that the FDA accepted the NDA for varegacestat for desmoid tumors, setting a PDUFA target action date of April 28, 2027. Phase 3 RINGSIDE data showed a statistically significant 84% reduction in the risk of disease progression or death versus placebo, with a 56% objective response rate. The company reported a Q2 net loss of $73.1 million and ended the period with $520.0 million in cash, which is expected to fund operations into 2028.

•2mo ago

Immunome Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Immunome granted inducement stock options covering 176,500 shares to nine new employees under Nasdaq Listing Rule 5635(c)(4). The options carry an exercise price of $23.01, equal to the closing price on the grant date, and vest over four years with a one-year cliff. The company is a clinical-stage oncology biotech focused on antibody-drug conjugates and gamma secretase inhibitors, including varegacestat.

•2mo ago

Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-3050, an FAP-Targeted Radioligand Therapy, in Patients with FAP-Expressing Advanced Solid Tumors

Immunome dosed the first patient in a Phase 1 trial evaluating IM-3050, an FAP-targeted radioligand therapy for patients with FAP-expressing advanced solid tumors. The open-label, multicenter study is designed to assess safety, tolerability, dosimetry, pharmacokinetics, and preliminary anti-tumor activity. IM-3050 is designed to deliver radioactive lutetium-177 directly to FAP-expressing cells, a target present in approximately 75% of solid tumors.

•3mo ago

Immunome Announces U.S. FDA Acceptance of New Drug Application for Varegacestat for the Treatment of Adults with Desmoid Tumors

Immunome announced that the FDA has accepted the New Drug Application for varegacestat for the treatment of desmoid tumors, setting a PDUFA target action date of April 28, 2027. The submission is supported by Phase 3 RINGSIDE trial data demonstrating an 84% reduction in the risk of disease progression or death compared to placebo, with an objective response rate of 56%. Management plans to submit a Marketing Authorization Application to the European Medicines Agency by the end of 2026 while the FDA review proceeds.

•3mo ago

Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-1617, a Potential First-in-Class ADC, in Patients with Advanced Solid Tumors

Immunome announced the first patient dosing in the Phase 1, first-in-human trial of IM-1617, a potential first-in-class antibody-drug conjugate (ADC) for advanced solid tumors. IM-1617 incorporates Immunome’s proprietary HC74 topoisomerase I inhibitor payload and targets an undisclosed receptor tyrosine kinase. The open-label, multicenter study will evaluate safety, tolerability, and preliminary anti-tumor activity in patients with colorectal, lung, and breast cancers. Management highlighted continued pipeline momentum, with IND submissions for additional ADCs IM-1340 and IM-1335 planned for mid- and late 2026, respectively.

•4mo ago

Immunome Announces Detailed Phase 3 RINGSIDE Data for Varegacestat in Adults with Progressing Desmoid Tumors at the 2026 ASCO Annual Meeting

Immunome presented detailed Phase 3 RINGSIDE data for varegacestat at ASCO, showing an 84% reduction in the risk of disease progression or death versus placebo (HR 0.16). The drug achieved a 56% objective response rate compared to 9% for placebo, with clinically significant pain reduction observed as early as week 4. An NDA was submitted to the FDA in April 2026, and a Marketing Authorization Application is planned for the European Medicines Agency by the end of 2026.

•5mo ago

Immunome Announces Submission of New Drug Application to U.S. FDA for Varegacestat for the Treatment of Adults with Desmoid Tumors

Immunome submitted a New Drug Application to the FDA for varegacestat for the treatment of adults with desmoid tumors. The submission is supported by Phase 3 RINGSIDE data showing an 84% reduction in the risk of disease progression or death and an objective response rate of 56%. Varegacestat demonstrated a median tumor volume reduction of 83% and a manageable safety profile, with detailed data set for presentation at the upcoming ASCO Annual Meeting.

•6mo ago