MoonLake announces FDA granted Fast Track designation for sonelokimab

MoonLake Immunotherapeutics (MLTX) 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.