MoonLake Says FDA May Allow Skin Drug Filing Without New Trials, Stock Soars

MoonLake Immunotherapeutics (NASDAQ:MLTX) on Thursday received U.S. Food and Drug Administration (FDA) feedback regarding the clinical evidence strategy for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS), based on the Type B meeting requested by MoonLake.SLK was associated with significant improvements across different key outcomes in over 1,000 patients with HS enrolled in the MIRA, VELA-1, and VELA-2 trials.DataMIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo ( ...