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MoonLake Immunotherapeutics (MLTX) Faces Investor Scrutiny After Reporting Disappointing Phase 3 Trial Data For Lead Drug Candidate -- Hagens Berman

Key Takeaway: MoonLake Immunotherapeutics (MLTX) reported disappointing results from its Phase 3 VELA-2 trial for sonelokimab, leading to a 90% drop in share prices. The trial failed to achieve statistical significance due to higher-than-expected placebo outcomes. In light of these results, Hagens Berman has launched an investigation into whether the company misled investors regarding the trial's design and efficacy. This situation has resulted in substantial financial losses for investors who believed in the drug's potential as the 'gold standard' treatment for hidradenitis suppurativa.

Market Sentiment Analysis

CONCERNS & RISKS

  • MoonLake Immunotherapeutics' shares plummeted 90% following disappointing Phase 3 trial results.
  • Investors are facing significant losses due to the failed efficacy of sonelokimab.
  • Hagens Berman is investigating potential misleading claims made by MoonLake regarding their trial data.

Full Press Release Details

SAN FRANCISCO, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Investors in MoonLake Immunotherapeutics (NASDAQ: MLTX) saw the price of their shares crater $55.75, or about 90%, after the company announced disastrous VELA-2 trial results for sonelokimab, its highly anticipated treatment for patients with skin disease (hidradenitis suppurative or “HS”).
The development and severe market reaction has prompted national shareholders rights firm Hagens Berman to open an investigation into whether MoonLake may have misled investors about sonelokimab’s trial design and efficacy.
The firm urges investors in MoonLake who suffered significant losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys.
Contact the Firm Now: MLTX@hbsslaw.com
MoonLake Immunotherapeutics (MLTX) Investigation:
The investigation is focused on MoonLake’s disclosures about the company’s planning for possible intercurrent events after participants start treatment and about the likelihood of achieving the HiSCR75 primary endpoint - a scale which defines treatment success as at least a 75% reduction in inflammatory lesions.
Before Sept. 29, 2025, MoonLake expressed confidence to investors in sonelokimab’s trial designs, encouraged the belief that the studies could show at least a 20% difference between the sonelokimab group and patients given a placebo, and has assured investors that “we really have a drug here that can become the gold standard and obviously that will facilitate any winning that we do with sonelokimab in HS.”
Investors’ expectations were dashed on Sep. 29, 2025, when MoonLake announced that in its VELA-2 trial “intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy (HiSCR75, delta to placebo of 9%[.]”
On this news, the price of MoonLake shares cratered $55.75 (-90%) that day, with one analyst reportedly writing in a note to investors that the results “‘arguably fall[] into the worst case outcome.’”
“We’re focused on investors’ losses and whether MoonLake may have misled investors about the VELA-2 design and planning for potential intercurrent events while claiming that sonelokimab could become a ‘gold standard’,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in MoonLake and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »
If you’d like more information and answers to frequently asked questions about the MoonLake investigation, read more »
Whistleblowers: Persons with non-public information regarding MoonLake should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email MLTX@hbsslaw.com.
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
Reed Kathrein, 844-916-0895

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Frequently Asked Questions

What caused the decline in MoonLake Immunotherapeutics' share price?

MoonLake's shares dropped 90% following disappointing VELA-2 trial results for sonelokimab.

What is the focus of Hagens Berman's investigation?

The investigation centers on potential misleading disclosures regarding trial design and efficacy.

What was the primary endpoint for the VELA-2 trial?

The primary endpoint was achieving at least a 75% reduction in inflammatory lesions.

How did investors react to the trial results announced on September 29?

Investors' expectations were shattered, leading to a significant drop in share price.

How can investors submit their losses related to MoonLake?

Affected investors can submit their losses by contacting Hagens Berman via email.

Last updated: Oct 9, 2025