MoonLake States FDA Might Permit Skin Medication Submission Without Additional Studies, Shares Surge

MoonLake Immunotherapeutics Receives FDA Feedback on Sonelokimab for Hidradenitis Suppurativa

On Thursday, MoonLake Immunotherapeutics (NASDAQ: MLTX) announced it had received guidance from the U.S. Food and Drug Administration (FDA) regarding its clinical evidence plan for Sonelokimab (SLK) in treating Hidradenitis Suppurativa (HS). This feedback followed a Type B meeting initiated by the company.

Across the MIRA, VELA-1, and VELA-2 clinical studies, which together enrolled over 1,000 HS patients, SLK demonstrated marked improvements in several important clinical measures.

Key Clinical Trial Results

• MIRA Study: At week 12, 43% of patients receiving 120mg SLK responded to treatment, showing a 29 percentage point improvement over placebo (p < 0.001).
• VELA-1 Study: This trial achieved all primary and major secondary goals, with statistically significant results across all planned analyses.
• VELA-2 Study: At week 16, 36% of participants on 120mg SLK responded, with a 10 percentage point difference compared to placebo (p = 0.033). However, a higher-than-expected placebo response prevented the study from reaching statistical significance using the main composite analysis (delta to placebo of 9%, p = 0.053).

Next Steps for MoonLake

Following the VELA trial outcomes, MoonLake sought further regulatory guidance from the FDA to support its Biologics License Application (BLA) preparations. The FDA indicated that the current clinical data may be sufficient to demonstrate SLK’s effectiveness in HS, and that additional trials may not be necessary.

The agency also recommended that the VELA-2 results be included in the marketing submission to provide additional safety information, regardless of their impact on the assessment of efficacy.

MoonLake remains on schedule with its BLA submission plans, aiming for the second half of 2026.

Merck’s Interest in MoonLake

In June 2025, reports surfaced that Merck & Co. Inc. (NYSE: MRK) made an acquisition offer to MoonLake Immunotherapeutics valued at over $3 billion, as Merck seeks to strengthen its portfolio ahead of the Keytruda patent expiration.

Stock Performance

MLTX shares surged 27.55%, reaching $14.40 in Thursday’s latest trading.

Image credit: Gorodenkoff via Shutterstock

Stock Overview

• MoonLake Immunotherapeutics (MLTX): $14.14, up 25.3%
• Merck & Co Inc (MRK): $110.11, up 1.40%