Bimekizumab

MLTX Investors with Losses Encouraged to Contact Hagens Berman SAN FRANCISCO, Nov. 6, 2025 /PRNewswire/ -- A securities class action, styled Bridgewood v. MoonLake Immunotherapeutics, et al., No. 1:25-cv-08500 (S.D.N.Y), has been filed after MoonLake ( NASDAQ: MLTX) announced disastrous Phase 3 trial results for its only product candidate (sonelokimab, or "SLK"), its highly anticipated treatment for patients with skin disease (hidradenitis suppurativa or "HS"). On this announcement, MoonLake investors saw the price of their shares crater $55.75, or about 90%, on September 29, 2025. The development and severe market reaction has prompted national shareholders rights firm Hagens Berman to investigate claims that, prior to September 28, 2025, MoonLake misled investors about SLK's trial design and efficacy data. 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. Class Period: Mar. 10, 2024 – Sep. 29, 2025 Lead Plaintiff Deadline: Dec. 15, 2025 Visit: Contact the Firm Now: [email protected] 844-916-0895 MoonLake Immunotherapeutics (MLTX) Securities Class Action: The litigation is focused on the propriety of MoonLake's statements about the trial design and data for SLK. The clinical stage biotechnology company is focused on skin inflammatory diseases driven by a cytokines known as IL-17A and IL-17F. Central to SLK's commercial prospects was its ability to demonstrate efficacy in HS comparable or superior to a competitor's FDA-approved product ("BIMZELX"), which is used for the same HS indication and targets the same cytokines. One difference between SLK and BIMZELX is that SLK's Nanobody structure is significantly smaller than BIMZELX's monoclonal antibody format. Throughout the Class Period, MoonLake repeatedly touted SLK's structural advantages as translating into superior efficacy. The company has said that SLK could achieve benefits "a monoclonal antibody cannot do," that "the molecular advantages of our Nanobody translate into higher clinical responses for patients," and that Nanobodies "offer a more convenient and effective treatment." MoonLake also 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." The complaint alleges that these, and other, MoonLake statements were false and misleading statements and that the company withheld crucial information from investors. More specifically, the lawsuit claims that the company misled investors about the distinction between Nanobodies and monoclonal antibodies, including that (1) SLK and BIMZELX share the same molecular targets (IL-17A and IL-17F), (2) SLK's Nanobody structure would not confer a superior clinical benefit over the traditional monoclonal structure of BIMZELX, and (3) SLK's Nanobody structure purported increased tissue penetration would not translate to clinical efficacy. Investors learned the truth on September 28, 2025 after MoonLake revealed that only one of its two SLK Phase 3 trials achieved statistical significance – and even those results demonstrated substantially lower efficacy than BIMZELX. On this news, the price of MoonLake shares cratered $55.75 (-90%) on September 29, 2025. The following day, securities analysts described the results as "a near worst-case scenario" and proclaimed the outcome a "disastrous result." "We're focused on investors' losses and whether MoonLake may have intentionally misled investors about the SLK's purported advantages over BIMZELX while claiming that SLK 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 case and our 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 [email protected]. About Hagens Berman 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. SOURCE Hagens Berman Sobol Shapiro LLP 21% more press release views with Request a Demo

UCB has gained an FDA approval for Kygevvi to treat a rare genetic mitochondrial disease. It is the third rare disease approval for the Belgian company in less than three years. UCB has scored an FDA approval for ultra-rare disease treatment Kygevvi, continuing the positive momentum for the Belgian company.The U.S. nod for Kygevvi—which is the third rare disease drug approval for the company in less than three years—is to treat the genetic mitochondrial disease thymidine kinase 2 deficiency (TK2d). It is the first targeted medicine for the muscle-weakening disorder. Kygevvi is cleared for adults and pediatric patients who have experienced symptom onset by age 12.When TK2d appears early in life, it increases the risk of rapid progression and death. It can be fatal within three years of symptoms emerging. TK2d strikes an estimated 1.64 in every 1 million people, affecting patients' ability to walk, eat and breathe independently.Kygevvi is an oral solution comprised of the pyrimidine nucleosides doxecitine and doxribtimine, which integrate into skeletal muscle mitochondrial DNA. This approach has been shown to restore the mitochondrial DNA copy number in TK2d mutant mice, UCB explained.“The approval of doxecitine and doxribtimine represents a pivotal moment for the TK2d community, who previously had no FDA-approved treatment options for this rare genetic mitochondrial disease beyond supportive [palliative] care,” Donatello Crocetta, the chief medical officer of UCB, said in a release.The company expects to launch Kygevvi in the first quarter of next year. The treatment is also under review by European regulators. The approval is backed by results from a phase 2 trial that showed Kygevvi reduced the risk of death by 86% when patients' outcomes were measured against an external control group of untreated patients. Participants in the two groups were matched up by age at symptom onset.“We have been waiting for an approved treatment for many years, and this approval marks a significant milestone in how we can support and manage this debilitating condition,” Michio Hirano, M.D., a professor of neurology at Columbia University’s Irving Medical Center, said in a statement.UCB has been on an upswing behind Bimzelx, which was approved for plaque psoriasis in 2023 and generated sales of 799 million euros ($918 million) in the first half of this year. Also contributing to the success have been myasthenia gravis drugs Rystiggo and Zilbrysq, both also approved in 2023, which produced combined sales of 239 million euros ($274 million) in the first half.  All told, UCB had a 25% increase in revenue in the first half of this year and followed in the third quarter with the highest market cap rise among top-20 companies in the industry at 41%.