IMMUNOME INC. DL -,0001

Immunome has treated the first patient in an open-label, multicenter phase 1 study of the radioligand therapy IM-3050, which delivers radioactive lutetium-177 selectively to FAP-expressing cells in advanced solid tumors. The study is evaluating safety, tolerability, dosimetry, pharmacokinetics and preliminary antitumor activity and includes a dose-escalation to determine the maximum tolerated dose followed by an expansion phase. Immunome notes a clinical pipeline with additional agents and a submitted regulatory application for Varegacestat; analysts have recently raised their earnings estimates and set price targets between $30 and $40. » Mere på de.investing.com

The FDA has accepted the New Drug Application (NDA) for varegacestat, an oral gamma-secretase inhibitor for the treatment of desmoid tumors in adults, and set the PDUFA date for April 28, 2027. The application is supported by the Phase 3 RINGSIDE study (156 patients), which met its primary endpoint and showed an 84% reduction in the risk of disease progression or death versus placebo (HR 0.16; p<0.0001); secondary endpoints and the objective response rate (56% vs. 9%) were also significantly better. The most common adverse events were diarrhea, fatigue, rash, nausea and cough, mostly grade 1–2. Immunome plans an EMA filing by the end of 2026; the company has a market capitalization of $2.76 billion and more cash than debt. » Mere på de.investing.com

Immunome presented in the phase‑3 RINGSIDE study in 156 patients with progressive desmoid tumors an 84% reduction in the risk of disease progression or death versus placebo (HR 0.16; p < 0.0001). The confirmed objective response rate was 56% with Varegacestat versus 9% with placebo, and there was early pain relief and a marked tumor volume delta favoring Varegacestat (week 24: −109.6 vs. +122.8; p < 0.0001). Common adverse events included diarrhea, fatigue, rash and nausea; dose reductions affected 80% of treated patients and 20% discontinued treatment due to adverse events. Immunome filed an NDA with the FDA in April 2026 and plans an EMA submission by the end of 2026; market capitalization is $2.47 billion. » Mere på de.investing.com