GLP-1 receptor agonist (Metaphore Biotechnologies Inc)

The FDA has pushed back by about a week its expedited reassessment of a partial clinical hold blocking long-term trials of Vanda Pharmaceuticals' tradipitant for motion sickness, now extending the deadline to Dec. 5. The original target, set as part of a collaborative framework negotiated after Vanda won an appellate court ruling over another drug, was Nov. 26.The shift was made "to accommodate recent personnel and leadership transitions" within the FDA's Center for Drug Evaluation and Research, according to the company. The agency recently named long-time oncology leader Richard Pazdur to lead the unit following the resignation of George Tidmarsh earlier in November.Vanda noted that the extension applies only to the agency's re-review of the partial clinical hold and that no other terms of the collaborative framework were modified.Meanwhile, the regulatory filing for tradipitant – an oral NK-1 receptor antagonist licensed from Eli Lilly – continues along its existing evaluation track for the prevention of vomiting associated with motion. The PDUFA action date remains Dec. 30 and Vanda said labeling discussions have formally begun following recent FDA comments on the proposed language.Tradipitant is also in development for nausea, where recent data showed it halved the amount of patients who experienced vomiting when taking Novo Nordisk's GLP-1 receptor agonist Wegovy (semaglutide) for weight loss. The FDA rejected approval of tradipitant for gastroparesis symptoms last year.Vanda has been engaged in various disputes with the agency over review practices, including concerning Hetlioz (tasimelteon), which the FDA had previously rejected as a treatment for jet lag. The FDA will conduct an expedited re-review of Vanda's application for Hetlioz by Jan. 7.

Bagsværd, Denmark, 24 November 2025 – Novo Nordisk today announced the top-line results from the 2-year primary analysis of evoke and evoke+ phase 3 trials in early-stage symptomatic Alzheimer’s disease. The two trials were randomised, double-blinded, enrolled a total of 3808 adults and evaluated the efficacy and safety of oral semaglutide compared to placebo on top of standard of care. The decision to pursue an Alzheimer’s disease indication with semaglutide was based on real-world evidence studies, pre-clinical models as well as post-hoc analyses from diabetes and obesity trials. The evoke and evoke+ trials did not confirm superiority of semaglutide versus placebo in the reduction of progression of Alzheimer’s disease, as measured by the change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) score compared to baseline. While treatment with semaglutide resulted in improvement of Alzheimer’s disease-related biomarkers in both trials, this did not translate into a delay of disease progression. In the evoke trials with patients aged 55-85, suffering from mild cognitive impairment or mild dementia due to Alzheimer’s disease, semaglutide appeared to have a safe and well-tolerated profile consistent with previous semaglutide trials. To date, more than 37 million patient-years of semaglutide exposure have occurred across diverse patient populations. “Based on the significant unmet need in Alzheimer’s disease as well as a number of indicative data points, we felt we had a responsibility to explore semaglutide’s potential, despite a low likelihood of success. We are proud to have conducted two well-controlled phase 3 trials in Alzheimer’s disease that meet the highest standards of research and rigorous methodology,” said Martin Holst Lange, chief scientific officer and executive vice president of Research and Development at Novo Nordisk. “We sincerely thank all participants and their caregivers for their meaningful contributions. While semaglutide did not demonstrate efficacy in slowing the progression of Alzheimer’s disease, the extensive body of evidence supporting semaglutide continues to provide benefits for individuals with type 2 diabetes, obesity, and related comorbidities.” The 1-year extension period in the evoke and evoke+ trials will be discontinued based on the efficacy results observed in the overall study population. Topline results from the evoke/evoke+ trials will be presented at the Clinical Trials in Alzheimer’s Disease (CTAD) conference on 3 December 2025, and full results at the 2026 Alzheimer’s and Parkinson’s Diseases Conferences (AD/PD) in March 2026. About Alzheimer’s disease Alzheimer's disease is the most common cause of dementia, accounting for 60-80% of all dementia cases worldwide. Dementia is a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer’s disease is a progressive disease, where symptoms gradually worsen over time. Each stage of the disease presents different challenges for those living with the disease and their care partners. There is a significant unmet need for new treatment options that can slow down the progression of Alzheimer’s disease and reduce the overall burden on people affected and on society. About Clinical Dementia Rating – Sum of Boxes The Clinical Dementia Rating scale (CDR) is a global measure of cognition and function obtained by interviewing both patient and care partner , commonly used staging tool for Alzheimer’s disease in research settings . It measures six areas covering cognition and function, where each area is scored between 0 (no dementia) and 3 (severe dementia). The summary score of the six areas (maximum score of 18), referred to as sum of boxes (CDR-SB) has been applied to clinical trials in Alzheimer’s disease to track progression and assess disease severity. In the evoke and evoke+ trials, the change in CDR-SB for semaglutide compared to placebo was measured from baseline to week 104. About the evoke/evoke+ studies Evoke and evoke+ are large-scale trials investigating the disease-modifying potential of semaglutide in people with Alzheimer’s disease. They are global, randomised, double-blind, placebo-controlled confirmatory phase 3 trials investigating the efficacy, safety, and tolerability of once-daily oral semaglutide 14 mg versus placebo in early-stage symptomatic Alzheimer’s disease. The trials included men or women aged 55–85 years with MCI (defined as CDR global of 0.5) or mild dementia due to Alzheimer’s disease (defined as CDR global score of 1.0) with confirmed amyloid positivity. In the evoke and evoke+ trials, 1,855 and 1,953 people respectively, were randomised 1:1 to semaglutide or placebo for 156 weeks (104-week main treatment phase and 52-week extension). About semaglutide Semaglutide is a GLP-1 receptor agonist marketed under the brand names Ozempic ® and Rybelsus ® for the treatment of type 2 diabetes, and Wegovy ® for the treatment of chronic weight management. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, X, LinkedIn and YouTube. Publication of inside information pursuant to Market Abuse Regulation, Article 17. Contacts for further information Company announcement No 37 / 2025