Press release
MoonLake Immunotherapeutics Announces Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day
MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy
About this update from Moonlake Immunotherapeutics
[{"type":"text","content":"MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS)FDA feedback confirms that the Company may establish substantial evidence of effectiveness (SEE), without additional clinical trials in HS, with a BLA consisting of data from its existing VELA-1, VELA-2 and MIRA trials The FDA specifically advised the Company to include the results of the MIRA trial in the submission and to submit the results of the VELA-2 trial for the marketing application to inform the safety profile of SLK, regardless of decisions on its utility in establishing SEEBased on the positive final official records of this Type B meeting MoonLake will continue its plans for BLA submission for SLK in HS in H2 2026An Investor Day to further discuss FDA feedback and value opportunities for SLK in HS and to share new clinical data, in HS and other indications, will be held on February 23rd, 2026 ZUG, Switzerland, January 8, 2026 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today provided an update following the positive feedback received from the U.S. Food and Drug Administration (FDA) regarding the clinical evidence strategy for SLK in 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. MIRA was the first placebo-controlled randomized clinical trial in HS using HiSCR75 as the primary endpoint and demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p To obtain regulatory clarity following the VELA readout and to continue the preparation of the BLA, MoonLake requested a Type B meeting with the FDA. The Company submitted a detailed briefing book with several additional analysis of the VELA data. The FDA indicated that MoonLake may establish substantial evidence of effectiveness (SEE) without additional clinical trials in HS, with an application consisting of data from its existing VELA-1, VELA-2 and MIRA trials. This supports the Company’s persp...