Investing.com -- MoonLake Immunotherapeutics (NASDAQ:MLTX) stock jumped 6.5% in premarket trading Monday after the company announced that the FDA has granted Fast Track designation to its sonelokimab (SLK) treatment for moderate-to-severe palmoplantar pustulosis (PPP).
The regulatory decision follows positive results from the Phase 2 LEDA trial and comes after recent FDA guidance confirming the company’s clinical evidence strategy for a planned Biologic License Application (BLA) submission for SLK in hidradenitis suppurativa (HS) in the second half of 2026.
Fast Track designation is designed to facilitate development and expedite review of drugs that treat serious conditions with unmet medical needs. For MoonLake, this means more frequent FDA interactions, potential eligibility for Accelerated Approval and Priority Review, and the ability to submit completed BLA sections on a rolling basis.
"This FDA decision marks an important milestone for MoonLake and for patients living with PPP," said Dr. Jorge Santos da Silva, Founder and CEO of MoonLake Immunotherapeutics. "It underscores the significant unmet need in this debilitating disease and SLK’s potential to address it."
The clinical-stage biotechnology company, which focuses on developing treatments for inflammatory diseases, also announced an upcoming Investor Day webcast scheduled for February 23, 2026. During this event, the company plans to present the Phase 2 S-OLARIS readout in axial spondyloarthritis (axSpA), discuss FDA feedback on hidradenitis suppurativa, and outline key catalysts for 2026.
MoonLake’s upcoming milestones include the primary endpoint readout of the Phase 2 S-OLARIS trial in axSpA in February 2026, 52-week data from VELA trials in HS in Q2 2026, and primary endpoint readouts for Phase 3 trials in psoriatic arthritis and adolescent HS in mid-2026.
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