MoonLake Immunotherapeutics shares advanced about 6% in premarket trading Monday following the release of one-year data from its Phase 3 VELA clinical program for sonelokimab in hidradenitis suppurativa.
The company reported that approximately 67% of patients receiving sonelokimab across the combined VELA-1 and VELA-2 trials achieved HiSCR75 at Week 52, while 33.1% of patients reached HiSCR100. Inflammatory remission, defined in the analysis as an IHS4-100 response, was achieved by 26% of treated participants.
Results were consistent between the two adult trials. VELA-1 recorded a HiSCR75 rate of 68.3% and a HiSCR100 rate of 31.2%. VELA-2 produced similar outcomes, with 66.0% of patients achieving HiSCR75 and 35.1% achieving HiSCR100. MoonLake noted that these endpoints compared favorably to the outcomes reported at the ends of trials for competing agents.
Patient-reported outcomes also showed improvements. In quality-of-life measures, mean HiSQOL score differences from baseline to the end of trial were -15.3 in VELA-1 and -14.8 in VELA-2. Nearly half of patients experienced at least a 3-point improvement on the worst skin pain score, according to the company disclosure.
MoonLake additionally shared interim Week 24 data from VELA-TEEN, the adolescent cohort in the program. Those early results indicated approximately 68% of adolescent patients achieved HiSCR75 and 45% reached HiSCR100 at the interim time point. The company reported no new safety signals in either the adult or adolescent trials.
Looking ahead, MoonLake plans to file a Biologics License Application for sonelokimab in hidradenitis suppurativa with the U.S. Food and Drug Administration at the end of September 2026. The submission will include adolescent patient data. The company expects to have clarity on the Prescription Drug User Fee Act, or PDUFA, target date by the end of November 2026.
MoonLake has scheduled an Investor Day for June 22, 2026, during which management will review the program data and outline upcoming milestones and guidance on next steps.
Contextual note - The data package includes adult Week 52 outcomes from VELA-1 and VELA-2 and interim Week 24 findings from VELA-TEEN. The company reported consistency across trials and improvements in both clinical response and patient-reported outcomes. The regulatory timeline centers on a planned BLA submission in late September 2026 and expected determination of the PDUFA date by late November 2026.