MoonLake Immunotherapeutics...New Data from Clinical Trials of its Nanobody Sonelokimab (Businesswire) - Nov 5, 2025 - "In an interim analysis of long-term data from MoonLake's Phase 3 clinical trials in adult patients with HS, the VELA-1 and VELA-2 trials, SLK demonstrates continuous clinical improvement and potentially competitive advantages beyond the week 16 primary endpoint. The Company confirmed a Type B meeting with the FDA, which is scheduled to be held on December 15, 2025, to discuss adequacy of the current clinical evidence package of SLK in HS to support a Biologics License Application (BLA)....An interim analysis of the VELA-TEEN clinical trial, a Phase 3 study of SLK in adolescent HS patients, showed that 46% of patients achieved a HiSCR75 response at week 16 (n=11)....The data is expected to be part of MoonLake's BLA submission."
FDA event • P3 data • Hidradenitis Suppurativa
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