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Hidradenitis suppurativa, often called HS, is not a condition most people have heard of, but for those living with it, it can be relentless. It is a chronic inflammatory skin disease that causes painful, recurring lumps, abscesses, and lesions, typically in areas where skin rubs together such as the armpits, groin, buttocks, and under the breasts. These lesions can rupture, drain, and leave significant scarring over time. The disease tends to begin in adolescence or early adulthood and often cycles through flares and partial remissions for years. Beyond the physical toll, the psychological burden is considerable; many patients report severe impacts on their quality of life, daily activities, and emotional wellbeing. Despite how disabling it can be, treatment options have remained limited.
For years, the primary approved treatment for moderate-to-severe HS has been adalimumab, sold as Humira by AbbVie Inc. (NYSE: ABBV), a TNF inhibitor originally approved for HS in 2015. While it offered some relief, clinical response rates were modest, leaving a large share of patients without meaningful long-term disease control. That gap is exactly what MoonLake Immunotherapeutics AG (NASDAQ: MLTX) is trying to fill.
MoonLake is a clinical-stage biotechnology company based in Zug, Switzerland, with no revenue yet. Its entire investment thesis rests on one asset: sonelokimab, a tri-specific Nanobody that targets both IL-17A and IL-17F simultaneously, two proteins involved in the inflammatory cascade that drives HS. The company has released one-year data from its Phase 3 VELA program, covering both VELA-1 and VELA-2 trials conducted in adults with moderate-to-severe HS.
The numbers were meaningful. Across both trials, 67.2% of patients treated with sonelokimab achieved what is called HiSCR75, a standardized measure of at least a 75% reduction in active lesion count, at the one-year mark. Around one third of patients reached HiSCR100, meaning complete lesion clearance. More than a quarter achieved what the company defines as inflammatory remission, a 100% reduction across abscesses, nodules, and draining tunnels. Quality-of-life scores showed patients moved, on average, from severe to mild impairment on the HS-specific quality-of-life scale. Nearly half reported a marked reduction in pain. No new safety signals emerged through Week 52.
For context, the 67% HiSCR75 rate exceeds what has been reported in other Phase 3 HS trials for competing agents, including a rival IL-17A/F inhibitor, where sonelokimab showed more than 10 percentage points of additional response across multiple endpoints. That kind of differentiation matters when you are approaching a regulatory filing. MoonLake has confirmed it expects to submit a Biologics License Application to the U.S. Food and Drug Administration by the end of September 2026, covering both adult and adolescent HS patients.
Markets responded. MLTX shares surged approximately 20% on the back of this data, with the stock trading near $23. Analysts had set an average 12-month price target of roughly $27.62 before the news, and at least one firm, Needham, had already raised its target to $30, with H.C. Wainwright maintaining a buy rating at $45. The gap between where the stock trades and where analysts believe it could go reflects both the upside potential and the risk inherent in any pre-revenue biotech. The BLA submission and subsequent FDA review will ultimately determine whether sonelokimab becomes the new standard of care in a disease that has waited far too long for a better answer.
