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ZUG, Switzerland - MoonLake Immunotherapeutics (NASDAQ:MLTX), a $3.94 billion market cap biotech company trading near its 52-week high of $62.75, announced Sunday that its Phase 3 VELA program testing sonelokimab in moderate to severe hidradenitis suppurativa (HS) showed mixed results, with one trial meeting its primary endpoint while the other narrowly missed statistical significance. According to InvestingPro data, the stock has shown remarkable strength with a 55% gain over the past six months.
The VELA-1 trial achieved statistical significance for its primary endpoint, with 35% of patients receiving sonelokimab achieving HiSCR75 (a 75% reduction in inflammatory lesions) compared to 18% for placebo (p
However, in the VELA-2 trial, sonelokimab failed to reach statistical significance for the primary endpoint under the pre-specified composite analysis strategy (p=0.053), despite showing a 36% response rate versus 26% for placebo. The company attributed this to a higher-than-expected placebo response.
When analyzed using an alternative pre-specified "treatment policy" statistical approach, both trials showed statistically significant improvements across all primary and key secondary endpoints, according to the company.
"We are encouraged by the results of VELA-1, which follow the expected performance of sonelokimab in all the important metrics for patients and treating physicians," said Prof. Kristian Reich, Founder and Chief Scientific Officer at MoonLake. The company maintains a strong financial position, with InvestingPro analysis showing more cash than debt on its balance sheet and a healthy current ratio of 16.65, indicating robust liquidity to support ongoing clinical development.
The safety profile remained consistent with previous studies, with no new safety signals detected. Common side effects included nasopharyngitis, headache, and upper respiratory tract infection. Oral candidiasis occurred in 7.3% of sonelokimab patients versus 0.4% for placebo.
MoonLake will now seek to confirm its regulatory path forward with authorities. The company continues development of sonelokimab across multiple inflammatory conditions, including psoriatic arthritis, axial spondyloarthritis, and palmoplantar pustulosis.
The announcement was based on a company press release statement.
In other recent news, Moonlake Immunotherapeutics has garnered attention following its second-quarter 2025 financial results. Guggenheim reiterated its Buy rating and maintained an $80.00 price target for the company. The firm’s analysis was influenced by the progress of Moonlake’s Phase III VELA clinical trials for sonelokimab in treating hidradenitis suppurativa. The VELA-2 trial has completed its last patient visit, while VELA-1 is expected to wrap up in August, with data analysis anticipated to take 4-6 weeks. In parallel, Clear Street also reaffirmed its Buy rating, setting a higher price target of $108.00. This confidence is driven by the potential of Moonlake’s SLK therapy, which is expected to be a significant treatment in the market. Both firms are looking forward to the pivotal trial data expected in September. These developments reflect ongoing interest and optimism in Moonlake’s therapeutic advancements.
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