MoonLake Immunotherapeutics Stock Drops 90% After Troubling Trial Results

MoonLake Immunotherapeutics Faces Investor Backlash

MoonLake Immunotherapeutics (NASDAQ: MLTX) found itself in hot water after reporting dire results from its Phase 3 VELA-2 trial for its flagship drug candidate, sonelokimab. On September 29, 2025, the company disclosed that intercurrent events led to the study failing to reach statistical significance at its primary endpoint, resulting in a dramatic drop in share price—down around $55.75, or a staggering 90%. This crash has not only frustrated investors but also raised questions regarding the company's transparency and communications about the trial's progress.

Following the news, the national law firm Hagens Berman announced a probe into MoonLake, suggesting that the company may have provided misleading statements regarding the trial design and outcomes. The firm is now appealing to investors who suffered financial losses to come forward and assist in the investigation. They are particularly focused on whether MoonLake properly disclosed its expectations for sonelokimab's performance and the potential impact of ongoing intercurrent events during the trials.

Before the shocking revelation, MoonLake had maintained a confident stance about sonelokimab’s potential to set a new standard for treating hidradenitis suppurativa (HS). They had led investors to believe that the Phase 3 trials would reveal a significant improvement over placebo controls, asserting that the drug could showcase a more than 20% difference in effectiveness. Statements from company executives were bullish, framing sonelokimab as a potential “gold standard” treatment.

The unexpected announcement shattered this narrative, revealing that unexpected developments in patient outcomes had derailed what many viewed as a strong therapeutic candidate. Analysts commented on the trial results, noting they represented one of the worst-case outcomes expected in this scenario, further exacerbating the concern among shareholders.

Reed Kathrein, a partner at Hagens Berman leading the investigation, expressed focus on whether MoonLake misled investors specifically regarding the VELA-2 trial’s design. Questions have arisen around how well the company communicated the likelihood of achieving the HiSCR75 primary endpoint, which requires a reduction of at least 75% in inflammatory lesions to be deemed successful.

Investors are now grappling with the fallout from this crash, particularly those who believed in the potential market influence of sonelokimab. The considerable drop in stock value reflects a collective feeling of shock and betrayal from shareholders who anticipated a different outcome based on the company’s prior assurances. Many are left wondering how a drug once hailed as a “breakthrough” could ascend to the pinnacle of market expectation only to plummet to the depths of disappointment.

In light of the unfolding situation, Hagens Berman continues to welcome insights from those familiar with MoonLake's operations that could help elucidate the circumstances surrounding the trial failures. Whistleblowers who possess private information regarding the company’s practices have been encouraged to come forward, potentially benefiting from the SEC Whistleblower program, which offers financial rewards for information leading to successful recoveries.

As this investigation moves forward, investors and stakeholders will be watching closely for any developments that could change the narrative surrounding MoonLake Immunotherapeutics, its leadership, and indeed sonelokimab itself. The market will keep its eyes peeled for any future communications from the company that could provide clearer insights into their plans moving forward and whether they will attempt to restore investor confidence after this severe rebound in stock performance.

Conclusion

MoonLake Immunotherapeutics now stands at a critical crossroads. The company must navigate the aftermath of disappointing trial results with transparency and clear communication strategies to regain the trust of its investors. Going forward, shareholders will be closely monitoring how the firm addresses these pivotal challenges, not just for the future of sonelokimab, but for the overall trajectory of the company in the competitive biotech space.