<p>MoonLake Immunotherapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) for the treatment of moderate-to-severe palmoplantar pustulosis (PPP). The designation is supported by positive Phase 2 LEDA trial results and is expected to facilitate more frequent interactions with the FDA, earlier and more frequent written communication, and eligibility for Accelerated Approval, Priority Review, and Rolling Review, if applicable. The company plans to submit a Biologic License Application (BLA) for SLK in hidradenitis suppurativa (HS) in the second half of 2026. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Moonlake Immunotherapeutics published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001162492-en) on February 02, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)</p>

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FDA Grants Fast Track Designation to MoonLake’s Sonelokimab for Palmoplantar Pustulosis