Press release
MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day
The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe
About this update from Moonlake Immunotherapeutics
[{"type":"text","content":"The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by positive results from the Phase 2 LEDA trialThe upcoming Phase 3 program will therefore be expected to benefit from earlier and more frequent interactions with the FDA under the Fast Track program, potentially enabling a more efficient development pathway This regulatory decision follows the recent clear guidance from the FDA, in which the Company confirmed its clinical evidence strategy for the planned submission of a Biologic License Application (BLA) in H2 2026 for SLK in hidradenitis suppurativa (HS)The PPP program will be discussed at the upcoming Investor Day webcast, confirmed for February 23, 2026, 8.00 – 9.30 am EST (2:00 – 3.30pm CET), including an open Q&A session The Company will also present the Phase 2 S-OLARIS readout in axial spondyloarthritis (axSpA) as the first in a series of rheumatology readouts expected in 2026, discuss FDA feedback, label strategy and new data for SLK in adult and adolescent hidradenitis suppurativa (HS), provide guidance for the upcoming psoriatic arthritis (PsA) Phase 3 IZAR readouts, and outline key catalysts for MLTXThe webcast can be accessed at: https://edge.media-server.com/mmc/p/ke4wbinp ZUG, Switzerland, February 2, 2026 – 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...