MoonLake Immunotherapeutics Achieves Positive Outcome with FDA

MoonLake Immunotherapeutics announced a "positive" outcome of its final pre-BLA meeting held on April 1 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 the acceptability of including the data from the MIRA clinical trial as a key part to establish SEE and to analyze the data consistent with the approach used for the VELA clinical trials. The FDA also agreed to the inclusion of the VELA-TEEN trial data for adolescent HS patients with the trial considered final and pivotal at the time of final BLA submission. MoonLake therefore expects to include patients aged 12 years and above in its label proposal and has notified the FDA of its intent to apply for Priority Review. Furthermore, the FDA agreed to the proposed approach for the clinical safety section and that the safety data will be analyzed primarily based on the VELA-1 and VELA-2 data as per the previous discussion with the FDA. MoonLake thus expects to include the full safety data also for VELA-2 as planned. Finally, the FDA agreed that other key elements including non-clinical studies and the proposed safety pools and analyses appear complete and appropriate for BLA filing and review. No remaining gaps, including in the FDA's Chemistry, Manufacturing, and Controls regulations, precluding the planned BLA submission were identified and no additional meetings are required as agreed between the FDA and MoonLake. With the overall structure of the label for HS aligned with the FDA, the Company is proceeding to build out the relevant sections of the label as planned, and as presented at the Investor Day on February 23, 2026. The proposed label is expected to include the MIRA trial's ~43% HiSCR 75 response rate and ~29 percentage point delta-to-placebo which are the highest observed values across any adequate and well-controlled clinical trial conducted in HS to date. Based on this feedback, MoonLake expects to submit the BLA for SLK in adult and adolescent HS to the FDA at the end of September 2026. Following this, the acceptance of the BLA submission is expected to be received within 60 days at which point the FDA will also notify MoonLake whether Priority Review has been granted. Subject to FDA approval, the first commercial launch in the United States is expected in the second half of 2027," the company stated.