MoonLake Immunotherapeutics Announces Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day

Core Viewpoint - MoonLake Immunotherapeutics received positive feedback from the FDA regarding the clinical evidence strategy for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS), indicating that substantial evidence of effectiveness can be established without additional clinical trials [1][5]. Group 1: Clinical Trial Results - SLK demonstrated significant improvements in key outcomes across over 1,000 patients in the MIRA, VELA-1, and VELA-2 trials, with MIRA showing a 43% response rate at week 12 and a 29 percentage point delta versus placebo (p < 0.001) [2][18]. - VELA-1 met all primary and key secondary endpoints with a 35% response rate at week 16 and a delta to placebo of 17 percentage points (p < 0.001) [2][18]. - VELA-2 achieved a 36% response rate at week 16 with a delta to placebo of 10 percentage points (p = 0.033), although a higher-than-expected placebo response affected the primary composite analysis [2][18]. Group 2: FDA Meeting and Regulatory Clarity - Following the VELA readout, MoonLake requested a Type B meeting with the FDA, which confirmed that existing trial data could support a Biologic License Application (BLA) without the need for additional clinical trials [3][5]. - The FDA advised that results from the MIRA trial should be included in the BLA submission, and VELA-2 results should inform the safety profile of SLK [3][5]. - The FDA excluded mechanistic evidence as confirmatory evidence for establishing substantial evidence of effectiveness for the HS indication [3]. Group 3: Future Plans and Investor Engagement - MoonLake plans to submit the BLA for SLK in HS in the second half of 2026, with an Investor Day scheduled for February 23, 2026, to discuss FDA feedback and new clinical data [5][7]. - The company is also preparing for a catalyst-rich roadmap over the next 12 months, including data releases from ongoing trials in Axial Spondyloarthritis and Psoriatic Arthritis [8]. Group 4: Market Opportunity and Unmet Need - Hidradenitis Suppurativa affects an estimated 2% of the population, with a significant unmet need for effective treatments, projected to create a market opportunity of $15 billion by 2035 [28]. - The disease has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions, highlighting the importance of developing effective therapies [28].