argenx NASDAQ: ARGX reported positive top-line results from its Phase III ALKIVIA trial of VYVGART Hytrulo in autoimmune myositis, meeting its primary endpoint in a combined population of patients with immune-mediated necrotizing myopathy, or IMNM, and dermatomyositis, or DM.
I am maintaining my "Strong Buy" rating on Immunome (IMNM). This decision is driven by FDA acceptance of varegacestat's NDA and a PDUFA date set for April 2027. The company's pipeline is diversified, with IM-1021 [ROR1 ADC] in phase 1 for B-cell lymphoma/solid tumors and initial data expected in 2026. The proprietary HC74 TOP1i payload in IM-1021 aims for best-in-class efficacy, targeting resistance and bystander effects beyond Merck's ROR1 ADC.
IMNM jumps 32% in a month. This comes as the FDA accepts varegacestat's NDA for desmoid tumors, with an approval decision expected by April 2027.
Immunome, Inc. (IMNM) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Immunome is evolving into a multi-asset targeted oncology platform, anchored by varegacestat's strong Phase 3 desmoid tumor data and an NDA submission. IMNM's cash position of $582.7M supports operations through 2028, enabling pipeline acceleration and mitigating near-term dilution risk. Varegacestat's efficacy (HR 0.16, ORR 56%) positions IMNM to challenge Ogsiveo in desmoid tumors, with broader TAM potential in ADCs and radioligand therapies.
9,438 shares were sold for a transaction value of ~$204,000 on April 2, 2026. This sale represented 30.02% of Higgins's holdings at the time.
Immunome (IMNM) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.
Immunome is advancing varegacestat for desmoid tumors, targeting NDA submission in Q2 2026 after positive phase 3 RINGSIDE data. Varegacestat demonstrated superior efficacy and safety versus nirogacestat, with an 84% risk reduction in progression or death and a 56% objective response rate. Despite a small addressable market (~3,000 patients), conservative peak global sales are estimated at $280 million, supporting a valuation over 235% above IMNM's current market cap.
Immunome (IMNM) delivered statistically significant phase 3 RINGSIDE results for varegacestat in progressive desmoid tumors, achieving an 84% risk reduction in progression or death compared to placebo. Varegacestat demonstrated a 56% objective response rate, the highest ever in a randomized desmoid tumor trial, and a marked reduction in tumor volume. I maintain a "Strong Buy" rating, supported by the upcoming NDA filing for varegacestat in Q2 2026 and IM-1021's phase 1 lymphoma data expected in 2026.
Immunome said on Monday its experimental drug met main goal in a late-stage study for patients with a rare type of tumor.
Immunome's lead asset, varegacestat, shows promising efficacy in desmoid tumors, with phase 3 topline data expected by the end of 2025. IMNM holds Orphan Drug designations in the US and Europe, potentially enabling accelerated approval if phase 3 results are positive. Cash reserves of $143.9M and marketable securities of $124.2M provide runway into 2027, despite a high annualized cash burn.
Immunome, Inc. (IMNM) came out with a quarterly loss of $0.5 per share versus the Zacks Consensus Estimate of a loss of $0.52. This compares to a loss of $0.49 per share a year ago.