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

Core Insights - MoonLake Immunotherapeutics received FDA feedback on the clinical evidence strategy for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS) following a Type B meeting request [1] - SLK showed significant improvements in key outcomes across over 1,000 patients in the MIRA, VELA-1, and VELA-2 trials [1] Data Summary - MIRA trial results indicated a 43% response rate with 120mg SLK, showing a 29 percentage point (ppt) improvement over placebo (p < 0.001) at week 12 [2] - VELA-1 trial met all primary and key secondary endpoints with statistical significance across all pre-specified analysis strategies [2] - In VELA-2, SLK achieved a 36% response rate with 120mg SLK at week 16, with a 10ppt delta to placebo (p = 0.033) [3] - A higher-than-expected placebo response affected the primary composite analysis in VELA-2, resulting in a 9% delta to placebo (p=0.053) [3] Regulatory Outlook - MoonLake requested a Type B meeting with the FDA to gain regulatory clarity and continue preparing for the Biologics License Application (BLA) [4] - The FDA indicated that substantial evidence of effectiveness for SLK may be established without additional clinical trials in HS [4] - The FDA advised that VELA-2 trial results should be included in the marketing application to inform SLK's safety, regardless of effectiveness decisions [4] Future Plans - MoonLake is on track to submit the BLA in the second half of 2026 [5] - In June 2025, Merck & Co. Inc. reportedly approached MoonLake with a bid exceeding $3 billion [5] - Following the latest developments, MLTX stock increased by 27.55% to $14.40 [5]