MoonLake Immunotherapeutics Faces Class Action Lawsuit After Disappointing Phase 3 Trial Results
In a significant development for investors, MoonLake Immunotherapeutics (MLTX) is facing a securities class action lawsuit due to disappointing results from a Phase 3 clinical trial for its only drug candidate, sonelokimab, abbreviated as SLK. This announcement, which indicated dire outcomes for the highly anticipated treatment targeting hidradenitis suppurativa (HS), has prompted substantial scrutiny from legal quarters. The lawsuit, titled Bridgewood v. MoonLake Immunotherapeutics et al., has been filed in the Southern District of New York and delves into the circumstances surrounding the company's reported trial data.
The problems for MoonLake came to light on September 28, 2025, when the company revealed that one of its Phase 3 trials did not yield statistically significant results, while the other showed efficacy far below that of its main competitor, BIMZELX. The revelation caused the share price of MoonLake to tumble by 90%, plummeting $55.75 in just one day, creating an urgent situation for investors who believed in the company's promises and projections.
At the heart of the class action is the assertion that MoonLake misled its investors regarding the drug's trial design, efficacy, and therapeutic benefits compared to BIMZELX, which also targets cytokines IL-17A and IL-17F. Lead plaintiffs claim that MoonLake's statements regarding SLK's advantages over BIMZELX were not only overly optimistic but also misleading, potentially amounting to securities fraud.
Throughout the class period, which spans from March 10, 2024, to September 29, 2025, MoonLake continuously highlighted SLK's structural benefits—employing a Nanobody format that is smaller compared to classic monoclonal antibodies. The company asserted such advantages, claiming they would lead to superior efficacy in treating conditions like HS. In fact, MoonLake branded SLK as a potential 'gold standard' in treatment, as it could supposedly achieve responses that traditional monoclonal antibodies could not. However, the recent trial results starkly contrast these assurances.
The lawsuit indicates that the efficacy data released by MoonLake was misleading. Moreover, it challenges the company's claims about the superiority of SLK's Nanobody format, suggesting that the anticipated clinical benefits were overstated. Invested parties were reportedly led to believe that the Nanobody would provide greater tissue penetration and effectiveness, a promise that has not materialized based on the recent trial outcomes.
Legal representatives from Hagens Berman, the firm filing the class action, are urging investors who have endured significant losses to share their experiences. The firm is also seeking additional evidence to bolster their claims against MoonLake. As the investigation unfolds, those familiar with the inner workings of MoonLake and its clinical trials may be poised to contribute crucial insights that could navigate the legal proceedings ahead.
The implications of this lawsuit are far-reaching, especially in regard to investor trust and the credibility of biopharmaceutical claims. If you or someone you know has been adversely affected by the recent revelations from MoonLake, consider reaching out to Hagens Berman to explore potential avenues for recovery. The firm has established a comprehensive resource page regarding this case, which is designed to assist affected parties in understanding their rights and options moving forward.
MoonLake Immunotherapeutics is now under intense scrutiny, both legally and in the public eye, following the substantial drop in share value and the subsequent class action lawsuit. As this situation continues to develop, the outcomes could reshape investor confidence in not just MoonLake itself, but could also invoke a broader impact on the biotech sector associated with misleading information and the legal ramifications that follow.