Shares of MoonLake Immunotherapeutics (NASDAQ:MLTX) rose 6.5% in premarket trading on Monday after the company disclosed that the U.S. Food and Drug Administration has granted Fast Track designation to its investigational drug sonelokimab (SLK) for the treatment of moderate-to-severe palmoplantar pustulosis (PPP).
The regulatory action follows positive findings from the Phase 2 LEDA trial and comes after recent interactions with the FDA that confirmed the company’s clinical evidence strategy for a planned Biologic License Application - BLA - submission for SLK in hidradenitis suppurativa (HS), targeted for the second half of 2026.
Fast Track designation is intended to facilitate the development and speed the review of drugs for serious conditions where unmet medical need exists. For MoonLake, the designation translates into more frequent communications with the FDA, potential eligibility for Accelerated Approval and Priority Review, and the opportunity to submit completed sections of a BLA on a rolling basis rather than waiting until the entire application is complete.
In response to the designation, Dr. Jorge Santos da Silva, Founder and CEO of MoonLake Immunotherapeutics, said: "This FDA decision marks an important milestone for MoonLake and for patients living with PPP. It underscores the significant unmet need in this debilitating disease and SLK’s potential to address it."
MoonLake, a clinical-stage biotechnology company focused on therapies for inflammatory diseases, also announced an Investor Day webcast scheduled for February 23, 2026. The company said it will present the Phase 2 S-OLARIS readout in axial spondyloarthritis - axSpA - discuss FDA feedback on hidradenitis suppurativa, and outline key catalysts planned for 2026.
The company listed several near-term clinical milestones. These include the primary endpoint readout from the Phase 2 S-OLARIS trial in axSpA expected in February 2026, 52-week data from the VELA trials in HS due in the second quarter of 2026, and primary endpoint readouts for Phase 3 trials in psoriatic arthritis and adolescent HS anticipated in mid-2026.
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MoonLake’s Fast Track designation for SLK in PPP is a regulatory development that could affect the company’s path toward potential approval for inflammatory indications, contingent on continued favorable clinical results and further regulatory interactions.