MoonLake Immunotherapeutics (MLTX) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its drug sonelokimab, aimed at treating moderate-to-severe palmoplantar pustulosis (PPP). The company's request for this designation was made on December 1, 2025. This news comes on the heels of successful discussions with the FDA, where MoonLake validated its clinical evidence strategy, aiming to submit a Biologics License Application (BLA) for sonelokimab in hidradenitis suppurativa (HS) in the latter half of 2026.
Additionally, MoonLake announced an Investor Day scheduled for February 23, 2026. The event will include comprehensive updates on clinical and regulatory progress across various indications, along with new data from the S-OLARIS study concerning sonelokimab in axial spondyloarthritis (axSpA).
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