MoonLake gets FDA clarity on SLK in HS; no new trials needed for BLA submission

MoonLake Immunotherapeutics

FDA confirms MoonLake can establish substantial evidence of effectiveness using existing VELA-1, VELA-2, and MIRA trials; no additional HS trials required.
BLA submission for Sonelokimab in HS on track for H2 2026; Investor Day set for Feb 23, 2026 to discuss FDA feedback and new data.
FDA advised including VELA-2 results in BLA to inform safety profile, regardless of role in establishing effectiveness.
Upcoming milestones: Phase 2 S-OLARIS (axSpA) Q1 2026; Phase 3 IZAR-1 (PsA) mid-2026; VELA-TEEN adolescent HS readout mid-2026.

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