Novo Nordisk A/S’ wild card bet that its GLP-1 receptor agonist semaglutide could be used to treat Alzheimer’s disease has not paid off, with the company reporting two phase III trials have shown no effect on slowing disease progression. The studies, Evoke and Evoke+, enrolled 3,808 patients with early stage symptomatic Alzheimer’s and the confirmed presence of amyloid plaque. They compared Rybelsus, the oral formulation of semaglutide that is approved for type II diabetes, with placebo, on top of standard of care. There was no improvement in the reduction of disease progression in the treatment arms, as measured by the change in Clinical Dementia Rating – sum of boxes, a global measure of cognition and function. Shares in Novo Nordisk (NYSE:NVO), already down more than 50% over the past year as Eli Lilly and Co. Inc. has taken the lead in the incretin anti-obesity market, fell further, dropping 8.6% to 3 in early trading Nov. 24, when the news was announced.
Bayer’s asundexian hits phase III stroke goal in win for FXIa drugs
Detailed data will be forthcoming at a scientific congress, but Bayer AG’s top-line readout from its phase III study testing oral factor XIa (FXIa) inhibitor asundexian in reducing the risk of ischemic stroke hit its primary efficacy endpoint. It marks the first successful phase III study for a drug targeting FXIa, a serine protease in the coagulation pathway, aimed at inhibiting thrombosis without ramping up bleeding risk. And while findings bode well for Bayer’s asundexian, which rebounded from disappointing phase III data in atrial fibrillation two years ago, they also offered a boost to competing programs, including milvexian, an oral FXIa inhibitor from Bristol Myers Squibb Co. and Janssen Pharmaceutical Co., in phase III testing in ischemic stroke, with data due late in 2026.
Nervgen scores in phase Ib/IIa effort for spinal cord injury
Nervgen Pharma Corp. CEO Adam Rogers hailed its candidate as “the only drug in spinal cord injury [SCI] at this point that’s making an impact” as the company made public expanded findings from the Connect phase Ib/IIa study with NVG-291 in SCI, showing that the 35-amino acid peptide derived from the intracellular wedge domain of phosphatase sigma provided durable functional gains that continued at week 16 and after. Rogers told BioWorld that his firm is “very aligned” with the U.S. FDA and will sit down with regulators for an end-of-phase II meeting early next year. Shares of the Vancouver, British Columbia-based company (CVE:NGEN) were trading at C.13 (US.92), up C13 cents.
New Samyang Holdings, Samsung Biologics spin-offs debut on Kospi
Two South Korean conglomerates – Samyang Holdings Corp. and Samsung Biologics Co. Ltd. – listed their newly spun-off biopharmaceutical units on Korea Exchange’s (KRX) main trading board Nov. 24. Seongnam-si, South Korea-based Samyang Biopharmaceuticals Corp.’s shares (KOSPI:0120G0) surged to the 30% limit on the first day of trading, ending at ₩30,200 (US0.46). Samsung Epis Holdings (KOSPI:0126Z0) closed at ₩438,500 (US00), down 28.23% from its opening price. The equity demergers and restructurings were expected to streamline corporate governance and give shareholders direct ownership, while bypassing traditional IPO book-building and subscription processes.
In lethal influenza, repair the lung before it’s too late
NIH researchers report that in severe influenza, survival improves at late stages only when antivirals are combined with therapies that repair lung damage or limit harmful T-cell responses, explaining why anti-inflammatory treatments alone are often ineffective. According to the World Health Organization’s Global Influenza Strategy 2019-2030, influenza causes an estimated 1 billion infections each year, of which 3-5 million are severe, and leads to approximately 290,000-650,000 influenza-related respiratory deaths. Fatal influenza is often marked by severe pneumonia in which lung damage stems less from the virus itself and more from a dysregulated innate immune response. The excessive inflammation triggered during infection can destroy healthy tissue and drive respiratory failure.
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