MoonLake Immunotherapeutics (MLTX) surged 43.58% in pre-market trading on Thursday, driven by positive developments including FDA feedback and plans for an Investor Day.
The company announced a positive outcome from a Type B meeting with the U.S. FDA, confirming it can establish SEE without additional trials. Additionally, MoonLake revealed plans to host an Investor Day on February 23, 2026, to discuss FDA feedback, share new clinical data, and outline its 2026 catalyst calendar.
Further boosting investor confidence, MoonLake disclosed plans to submit a Biologics License Application (BLA) for SLK in HS in the second half of 2026, signaling progress in its pipeline.
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