MoonLake Immunotherapeutics Announces FDA Grants Fast Track Designation For Sonelokimab To Treat Moderate‑To‑Severe Palmoplantar Pustulosis

MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake" or the "Company"), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announces that the FDA has granted Fast Track designation for sonelokimab for the treatment of moderate‑to‑severe PPP. MoonLake had submitted a request for Fast Track designation on December 1, 2025. This follows the positive outcome of the Company's recent FDA interactions in which it confirmed its clinical evidence strategy for the planned submission of a BLA for SLK in HS in H2 2026. The Company also confirmed details for its upcoming Investor Day, which will take place on February 23, 2026, featuring in‑depth clinical and regulatory updates across multiple indications, including newly generated data from the S‑OLARIS program for SLK in axSpA.

Fast Track is an FDA program designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Its purpose is to help important new therapies reach patients earlier. Granting Fast Track designation is generally based on whether a drug has the potential to improve survival, enhance day‑to‑day functioning, or prevent a condition from progressing from a less severe to a more serious stage.