MoonLake Immunotherapeutics Faces Investor Backlash Following Poor Phase 3 Trial Results

MoonLake Immunotherapeutics Faces Intense Investor Scrutiny

MoonLake Immunotherapeutics (NASDAQ: MLTX) found itself at the center of a storm following a severe decline in share prices after announcing the disappointing results of its Phase 3 clinical trial for sonelokimab, a treatment aimed at managing hidradenitis suppurativa (HS), a chronic skin condition.

On September 29, 2025, the company disclosed that the VELA-2 trial results were far from the expectations set previously, leading to a staggering 90% decrease in its stock price, which plummeted by $55.75. Investors had shown confidence in the potential of sonelokimab, with hopes that it could set a new standard in the treatment of HS. However, the trial's findings proved to be a harsh reminder of the unpredictability inherent in clinical research.

The investigation conducted by Hagens Berman, a national shareholder rights law firm, focuses on whether MoonLake may have misled its investors regarding the trial's design and outcomes. Prior to the trial's announcement, the firm had publicly expressed optimism about sonelokimab’s efficacy, stating that the studies would likely demonstrate a significant advantage over placebo treatments. Reports indicated that MoonLake management claimed their drug was not only viable but could potentially become the “gold standard” in HS treatment.

However, the VELA-2 results revealed that unexpected intercurrent events in the placebo group hindered the trial from reaching statistical significance regarding its primary endpoint. These results contradicted the earlier assurances given to investors, leading to accusations of possible misleading communications concerning the trial's expectations and design.

As the fallout from this trial continues, concerns are mounting regarding the information disclosed by MoonLake and the decisions made by its leadership. Hagens Berman is eager to determine if there were discrepancies between what was communicated to investors and the actual developments in the trial's design and execution, particularly surrounding the planning for potential intercurrent events that are common in clinical trials.

Reed Kathrein, a partner at Hagens Berman overseeing the inquiry, emphasized the focus on investors' losses and the critical importance of transparency in the clinical trial process. “We're dedicated to uncovering the truth concerning any potential miscommunications from MoonLake about the VELA-2 study, especially concerning its claims of sonelokimab’s potential,” he noted. This investigation reflects a broader concern within the investment community where trust in corporate communications is paramount, especially in high-stakes areas like biotechnology where patient welfare and investor interests are significantly intertwined.

For investors who have suffered losses following this débâcle, Hagens Berman invites individuals to come forward and share their experiences. Furthermore, those who possess insider knowledge related to MoonLake's disclosures or its VELA-2 trial may find opportunities to assist in the ongoing investigation or benefit from securities whistleblower incentives.

As MoonLake navigates this turbulent period, it remains to be seen how the company will address these allegations and what steps will be taken to restore investor confidence. The outcomes of this investigation could have significant ramifications not just for MoonLake but for the broader biopharmaceutical industry, reinforcing the need for accountability, diligence, and clear communication in clinical research and financial disclosures.