MoonLake submits BLA for sonelokimab in hidradenitis suppurativa
The company filed its application with the FDA on September 30, 2026, and expects to hear on acceptance within about two months.
MoonLake Immunotherapeutics disclosed in a Form 8-K that on September 30, 2026 it filed a Biologics License Application with the U.S. Food and Drug Administration for sonelokimab, a tri-specific nanobody, aiming to treat moderate-to-severe hidradenitis suppurativa in adults and in pediatric patients aged 12 and older.1
The company said it anticipates hearing from the FDA on whether the application will be accepted for review roughly 60 days after filing, and expects to learn the agency's planned review schedule about 74 days after submission.1
The filing included standard forward-looking statement cautions. MoonLake noted that its outlook statements cover whether and when the FDA will accept the BLA, when it will receive the review timeline, and the possible approval, approval timing, and commercial launch of sonelokimab.1 The company also flagged broader risks, including its limited operating history, challenges in enrolling patients in clinical trials, potential healthcare reform measures that could cut demand for its products, and its dependence on third parties to run preclinical and clinical studies.1
The 8-K was signed by Chief Financial Officer Matthias Bodenstedt on the date of filing. No additional details on trial data or commercial terms were included in the report.
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