MoonLake Immunotherapeutics (MLTX), Monday announced that the U.S. Food and Drug Administration has granted Fast Track designation to sonelokimab for the treatment of moderate-to-severe palmoplantar pustulosis.
The move comes after the company's recent interactions with FDA, during which it confirmed its clinical evidence strategy for the planned submission of a Biologic License Application for sonelokimab in hidradenitis suppurativa in the second half of 2026.
With this Fast Track designation, the company aims to accelerate its Phase 3 program through earlier and more frequent FDA engagement.
In the pre-market hours, MLTX is climbing 7.28 percent, to $16.73 on the Nasdaq.
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