Novo Nordisk A/SNOV
▲ PositiveRegulationrelevance
CHMP positive opinion recommends EU marketing authorisation for FREHEMGO (denecimig) in haemophilia A, advancing the first FVIIIa mimetic with monthly-to-weekly dosing toward EU launch.
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Biotech & Genomic Medicine▲ · 1 stocks
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Novo Nordisk's Frehemgo wins EMA panel backing for hemophilia A
A European Medicines Agency panel has recommended approval of Frehemgo, Novo Nordisk's injectable treatment for hemophilia A, moving the Danish drugmaker closer to another commercial opportunity outside its diabetes and obesity franchise. The recommendation covers adults and children, including patients with or without inhibitors, and follows results from Novo's FRONTIER clinical program, in which Frehemgo reduced annualized bleeding rates compared with previous clotting-factor preventive treatments and therapies given when bleeding occurred. Novo plans to sell Frehemgo in a single-use, prefilled pen with dosing options ranging from once weekly to once monthly, offering patients more flexibility. The European Commission still needs to give final approval, but Novo is already preparing for commercialization and expects to introduce Frehemgo in a selected European market during the fourth quarter, followed by a broader European Union rollout early next year. The next catalyst is European Commission approval and whether Novo can begin that first launch before year-end.
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Kamada Says KedRAB Supply Adequate as U.S. Rabies Cases Rise
Kamada said it maintains an adequate supply of KedRAB, its human immune globulin targeting rabies, even as cases linked to the viral disease rise in the United States. The Israeli biotech's shares traded higher on Thursday following the statement. Last week the CDC issued a health advisory reporting a significant increase in human rabies exposures and the use of rabies post-exposure prophylaxis, with a 17% increase in rabies-related inquiries from July through August and a 76% rise in the utilization of two U.S.-licensed rabies immunoglobulins for the week ending Sept. 2. Kamada said that in light of the increase in end-user utilization described in the CDC advisory, it has the inventory and manufacturing capacity to support continued supply of KedRAB. With its Q2 2026 results in August, Kamada reiterated its full-year guidance for revenue and adjusted EBITDA at $200M–$205M and $50M–$53M, implying 12% and 23% year-over-year growth respectively.
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Weiguang Biological's Belarus Blood Transfusion Center Cooperation Project Officially Delivered, Completing China's First Export of Blood Product Technology
Weiguang Biological has received the third-stage acceptance report issued by the Belarusian state institution, the Republican Scientific and Practical Center for Transfusiology and Medical Biotechnologies, marking the successful completion and delivery of the Weiguang Biological–Belarus Blood Transfusion Center blood product cooperation project. The company has thus become the first Chinese enterprise to complete the export of blood product technology. The project officially began in December 2022 and was implemented in three major stages, with all tasks in each stage passing acceptance on the first attempt. In December 2023, Weiguang Biological completed the verification and delivery of technical documents. In October 2024, Belarusian technical personnel came to China for full-time training and all successfully completed the program. Afterward, Weiguang Biological traveled to the Gantsevichi base to conduct production condition inspections and on-site process guidance, successfully completing the trial production of human albumin and intravenous human immunoglobulin as stipulated in the contract. Through cross-testing by both parties, all indicators of the semi-finished and finished products met the standards of the Pharmacopoeia of the People's Republic of China and the relevant Belarusian quality standards. The Belarusian Blood Transfusion Center highly praised Weiguang Biological's professional technical capabilities.