MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day

Core Insights - The FDA has granted Fast Track designation for sonelokimab (SLK) for the treatment of moderate-to-severe palmoplantar pustulosis (PPP), highlighting the significant unmet medical need in this area [1][3][5] - MoonLake Immunotherapeutics plans to submit a Biologic License Application (BLA) for SLK in hidradenitis suppurativa (HS) in the second half of 2026, following positive FDA interactions [1][5] - An Investor Day is scheduled for February 23, 2026, where the company will provide updates on clinical and regulatory progress across multiple indications, including new data from the S-OLARIS program for SLK in axial spondyloarthritis (axSpA) [1][4][5] Fast Track Designation - Fast Track is an FDA program aimed at expediting the development and review of drugs for serious conditions with unmet medical needs, allowing for earlier patient access to important new therapies [2] - The designation for SLK in PPP reflects the severe burden of the condition and the lack of approved treatments, enabling a streamlined development process [3][5] - Benefits of the Fast Track designation include more frequent FDA interactions, potential eligibility for Accelerated Approval and Priority Review, and the possibility of a Rolling Review for BLA submissions [3][5] Clinical Development and Upcoming Milestones - The Phase 2 LEDA trial for SLK in PPP showed significant clinical benefits, with a mean percent change in the Palmoplantar Psoriasis Area and Severity Index (PPPASI) of 64% at week 16, and 39% of patients achieving a ≥75% reduction [19] - The upcoming Phase 3 program for SLK in PPP is expected to benefit from the Fast Track designation, allowing for more efficient development pathways [5] - Key upcoming milestones include the primary endpoint readout of the Phase 2 S-OLARIS trial in axSpA in February 2026, and the BLA submission for HS in H2 2026 [15][5] Company Overview - MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on developing sonelokimab, a novel investigational Nanobody targeting inflammatory diseases [9] - The company aims to address significant unmet needs in conditions such as hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis, and palmoplantar pustulosis, which affect millions globally [9][35] - Sonelokimab works by inhibiting IL-17A and IL-17F, key drivers of inflammation in these diseases [12][9]