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MoonLake submits BLA to FDA for sonelokimab to treat moderate-to-severe hidradenitis suppurativa in adults and pediatric patients aged 12 and older
MLTXMoonLake Immunotherapeutics
On September 30, 2026, MoonLake Immunotherapeutics submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for its tri-specific nanobody sonelokimab to treat moderate-to-severe hidradenitis suppurativa in adults and pediatric patients aged 12 and older. The company anticipates receiving notification on whether the BLA is accepted for review within approximately 60 days of submission, with the planned review timeline expected within roughly 74 days. MoonLake Immunotherapeutics operates as a clinical-stage biopharmaceutical company focused on developing immunotherapies.