MoonLake Immunotherapeutics Could Win FDA Approval for Sonelokimab by Year-End 2027, Wedbush Says

MT newswire2026/10/05 15:26

11:26 AM EDT, 10/05/2026 (MT Newswires) -- MoonLake Immunotherapeutics (MLTX) could receive US Food and Drug Administration approval for sonelokimab as a treatment for hidradenitis suppurativa by year-end 2027, with the completed BLA submission representing a key milestone, Wedbush Securities said in a Monday note. The company has completed its biologics license application, or BLA, for sonelokimab and has also requested a priority review designation, the brokerage said. The FDA's acceptance of the BLA should be a positive catalyst for MoonLake, regardless of review designation, according to the note. MoonLake's 52-week data from two phase 3 studies of sonelokimab showed the product candidate has "at least comparable efficacy" to bimekizumab, an approved treatment for the same indication, the investment firm said. The brokerage added that a decision on the filing should be released within 60 days, by the end of November, and that the review designation should be confirmed within 74 days of filing, based on the review timeline. Wedbush has an outperform rating and a $34 price target on MoonLake. Price: 11.29, Change: -0.12, Percent Change: -1.05

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