MoonLake submits FDA BLA for sonelokimab in hidradenitis suppurativa
MLTX•MoonLake Immunotherapeutics filed an FDA biologics license application on Sept. 30, 2026, seeking approval of sonelokimab for adults and patients aged 12 or older with moderate-to-severe hidradenitis suppurativa; an FDA acceptance decision is expected within about 60 days, with a review timeline expected within about 74 days.
1. FDA application filed
MoonLake Immunotherapeutics filed a biologics license application with the FDA on Sept. 30, 2026, for sonelokimab in moderate-to-severe hidradenitis suppurativa. The application seeks use in adults and pediatric patients aged 12 years or older; an FDA acceptance decision is expected within about 60 days, and a review timeline is expected within about 74 days.
