MoonLake expects FDA notice on review acceptance within approximately 60 days and a planned review timeline within approximately 74 days of submission.
MoonLake Immunotherapeutics (MLTX) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration on September 30, 2026, seeking approval of sonelokimab, a tri-specific nanobody, for moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 years of age and older. MoonLake expects to be notified whether the FDA accepts the application for review within approximately 60 days of submission and to receive the planned review timeline within approximately 74 days of submission.
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