MoonLake Immunotherapeutics Announces Positive Regulatory Feedback from Both FDA and EMA on Path for the Phase 3 Program for the Nanobody Sonelokimab in Psoriatic Arthritis

MoonLake Immunotherapeutics announced the successful outcome of its end-of-Phase 2 interactions with the FDA, as well as positive feedback from its interactions with the EMA, with both regulatory bodies unanimously supporting the Company's proposed approach for advancing its Phase 3 program of SLK in PsA. The Phase 3 program, named IZAR, is expected to enroll around 1,500 patients and, in combination with data from the Phase 2 ARGO trial, is designed to support a Biologics License Application and E.U. Marketing Authorization Application.