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MoonLake Immunotherapeutics clears final FDA pre-BLA meeting, plans submission for sonelokimab in hidradenitis suppurativa by Sept 2026

Company Fundamentals
10 May 2026
GlobeNewsWire
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Bullish
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MoonLake Immunotherapeutics announced a positive outcome from its final pre-BLA meeting with the U.S. FDA, agreeing on submission plans and labeling strategy for sonelokimab in treating hidradenitis suppurativa (HS). The FDA accepted key clinical trial data, including adolescent patient data, with no remaining gaps identified, enabling a planned BLA submission by the end of September 2026 and potential Priority Review by November 2026. MoonLake ended Q1 2026 with $357.9 million in cash and expects to fund operations through 2027. Upcoming milestones include further clinical trial data releases and the anticipated commercial launch in the U.S. in the second half of 2027.

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