MoonLake Phase 3 VELA Week 52: 67% HiSCR75, 33% HiSCR100; BLA submission end-Sept 2026

MoonLake Immunotherapeutics

Across VELA-1/2, 67.2% of SLK-treated patients achieved HiSCR75, 33.1% HiSCR100 at Week 52 (n=396).
26.0% achieved IHS4-100 remission; HiSQOL improved by mean -15.0 points from baseline.
46.5% of patients had marked pain reduction (≥3-point drop in worst skin pain NRS).
VELA-TEEN interim: ~68% HiSCR75, ~45% HiSCR100 at Week 24 in adolescents (n=22).
BLA submission for SLK in HS expected end of September 2026; PDUFA date by late Nov 2026.

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