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MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day

MoonLake Immunotherapeutics (MLTX)MoonLake ImmunotherapeuticsFDA / regulatory

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 trial The upcoming Phase 3 program will therefore be expected to

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MoonLake Immunotherapeutics

MoonLake Immunotherapeutics is a biotechnology company focused on inflammatory skin and immune-mediated diseases. Its story is built around developing differentiated therapies for conditions like hidradenitis suppurativa and other inflammatory disorders.

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19.88 USD
Market cap
1.32B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States