IMMUNOME INC. DL -,0001

At the H.C. Wainwright conference, Immunome presented a two‑pronged strategy: in the short term, securing FDA approval and commercial launch of Varegacestat for desmoid tumors (PDUFA date set); and in the long term, building a broad ADC portfolio. The lead program is the ROR1‑targeted ADC IM‑1021, with the goal of achieving breakthrough designation through strong efficacy. The company highlights its HC74‑Topo1 payload platform and plans to develop at least 10 novel ADCs, but discloses no financial figures and points to the typical risks of early drug development. » Mere på de.investing.com

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

Aristotle Core Equity Fund disclosed a new position in Immunome, highlighting positive phase 3 data for Varegacestat in desmoid tumors and plans to file for FDA approval with a potential commercial launch in late 2026 or early 2027. The fund noted Immunome’s experienced leadership under Clay Siegall, a portfolio of clinical- and preclinical-stage programs, and pro forma cash exceeding $600 million after a recent capital raise. Immunome’s market capitalization is about $2.37 billion and the shares climbed roughly 160% over the past 52 weeks, though they fell about 13.9% in the prior month. » Mere på finance.yahoo.com