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MoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the U.S. FDA and Reports First Quarter 2026 Financial Results
MoonLake conducted a positive final pre-BLA (Biologics License Application) meeting with the U.S. Food and Drug Administration (FDA), where MoonLake and the
About this update from Moonlake Immunotherapeutics
[{"type":"text","content":"MoonLake conducted a positive final pre-BLA (Biologics License Application) meeting with the U.S. Food and Drug Administration (FDA), where MoonLake and the FDA aligned on submission plans and the label strategy for sonelokimab (SLK) in hidradenitis suppurativa (HS)This included the acceptability of MIRA trial data to establish substantial evidence of effectiveness (SEE), full inclusion of the VELA-TEEN trial data for a label including patients aged 12 years and above, and the strategy for inclusion of safety data across the MIRA and VELA trials – this aligns with the scenario presented at the Investor Day on February 23, 2026The proposed label in HS is therefore expected to include the MIRA trial’s ~43% HiSCR75 response and the ~29 percentage point delta-to-placebo at week 12, which are the highest values observed across any adequate well-controlled clinical trial conducted in HS to dateWith no remaining gaps identified, the pre-BLA process for HS is complete, and the BLA submission to the FDA is planned for the end of September 2026; acceptance, including a decision on Priority Review designation associated with the inclusion of VELA-TEEN adolescent data, is expected by end of November 2026Other clinical trials of SLK are progressing well and are expected to support a catalyst-rich roadmap over the next 12 months, including the release of 52 weeks data from the Phase 3 VELA clinical trials and week 16 read-outs from the Phase 3 IZAR clinical trials in Psoriatic Arthritis (PsA)MoonLake ended the first quarter with $357.9 million in cash, cash equivalents and short-term marketable debt securities and expects to have a cash runway to the end of 2027; additionally, up to $400 million in non-dilutive funds remain available through its debt facility with Hercules Capital ZUG, Switzerland, May 10, 2026 – MoonLake Immunotherapeutics (NASDAQ: MLTX) (“MoonLake” or the “Company”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced a positive outcome of its final pre-BLA meeting held on April 1, 2026, with the FDA on the HS program of its Nanobody® SLK. During the meeting, MoonLake and the FDA aligned on the submission plans and the label strategy, the approach to include adolescent HS data in the BLA, and the safety data strategy. Specifically, the FDA re-confirmed t...