In October 2025, BioWorld tracked 252 clinical trial updates across phases I-III, roughly in line with September’s 230 but markedly higher than the 95 logged in August. Of those, 27 phase III studies reported positive results, while four disclosed failures. Clinical trial updates logged by BioWorld in October comprised 91 phase I reports, 75 from phase II, and 87 from phase III studies.
Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.
Vigencell Inc. plans to seek conditional approval in South Korea for VT-EBV-N, an antigen-specific killer T-cell therapy for natural killer T-cell lymphoma, after gaining positive top-line data from a phase II study Nov. 25.
Edwards Lifesciences Corp. released data from a health economics study done across nine countries in Europe which showed that early transcatheter aortic valve replacement in patients with asymptomatic severe aortic stenosis can deliver significant economic benefits alongside improved clinical outcomes.
Success in Japan may further bolster Protara Therapeutics Inc. in its push with TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), for which the New York-based firm disclosed interim results from an ongoing phase II trial.
Otsuka Pharmaceutical Co. Ltd. filed an NDA with the U.S. FDA for centanafadine (formerly EB-1020), a new nonstimulant therapy for treating attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Centanafadine is a norepinephrine, dopamine and serotonin reuptake inhibito formulated as a once-daily extended-release capsule.
In a phase II study, Novo Nordisk A/S’s amycretin reduced the weight of type 2 diabetes patients by 14.5% in 36 weeks, a statistically significant loss. The results also produced reduced hemoglobin A1C levels, an average of blood glucose that is used to monitor blood sugar control, below 7% in up to 89.1% of the participants.
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
Detailed data will be forthcoming at a scientific congress, but Bayer AG’s positive top-line readout from its phase III study testing oral factor XIa (FXIa) inhibitor asundexian in reducing the risk of ischemic stroke offered a much-needed win for the FXIa space, which encountered its latest stumble just over a week ago.
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.
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