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 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 ...