MoonLake files FDA BLA for sonelokimab in hidradenitis suppurativa

MoonLake Immunotherapeutics

BLA submitted September 30, 2026 seeking approval of tri-specific nanobody sonelokimab for moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 and older.
MoonLake expects FDA notice on whether the BLA is accepted for review within roughly 60 days of submission, and the planned review timeline within roughly 74 days.
Filing discloses no efficacy, safety, pricing or financial data; the 8-K reports only the regulatory submission milestone.
Risks cited include limited operating history, difficulty enrolling patients in clinical trials, and reliance on third parties for trials; signed by CFO Matthias Bodenstedt.

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