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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 faced significant investor backlash after its Phase 3 trial data for sonelokimab revealed disappointing results, causing a 90% drop in share price. The firm Hagens Berman has initiated an investigation into potential misrepresentations about the drug's trial design and expected outcomes. Failure to meet statistical significance in trial endpoints has raised concerns among stakeholders regarding the company's transparency and future prospects.

Market Sentiment Analysis

CONCERNS & RISKS

  • MoonLake's lead drug candidate sonelokimab reported disastrous Phase 3 trial results.
  • The company's share price plummeted by about 90% following the announcement.
  • Hagens Berman is investigating potential misleading information provided to investors regarding the trial's design and efficacy.

Full Press Release Details

SAN FRANCISCO, Oct. 03, 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 drop in MoonLake Immunotherapeutics' share price?

The share price fell 90% after the company reported poor VELA-2 trial results.

What was the treatment tested in the VELA-2 trial?

The VELA-2 trial tested sonelokimab for treating hidradenitis suppurativa.

What is the focus of Hagens Berman's investigation?

The investigation examines whether MoonLake misled investors about trial efficacy.

What was the expected outcome for sonelokimab in trials?

Investors anticipated a 20% difference in results between sonelokimab and placebo.

How can investors report losses related to MoonLake?

Investors can submit their losses to Hagens Berman for potential investigation.

Last updated: Oct 3, 2025