Roche reports positive data from the Phase I/II NXTAGE study of NXT007, an investigational next-generation bispecific antibody, in people with hemophilia A, supporting its progression to Phase III clinical development.
These data suggest that NXT007 may have the potential to provide hemostatic normalization in people with hemophilia A (without factor VIII inhibitors) with a tolerable safety profile.
These results were presented orally at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress, held 21-25 June in Washington, D.C. Three Phase III clinical studies of NXT007 are expected to begin in 2026.
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Roche Holding AG (Roche) is a research-based healthcare company. The Company's operating businesses are organized into two divisions: Pharmaceuticals and Diagnostics. The Pharmaceuticals Division consists of two business segments: Roche Pharmaceuticals and Chugai. The Diagnostics Division consists of four business areas: Diabetes Care, Molecular Diagnostics, Professional Diagnostics and Tissue Diagnostics. The Company develops medicines for various disease areas, including oncology, immunology, infectious diseases, ophthalmology and neuroscience. Its pharmaceutical products include Anaprox, Avastin, Bactrim, Bondronat, CellCept, Cotellic, Dilatrend, Dormicum, Invirase, Kadcyla, Kytril (Kevatril), Lariam, MabThera, Madopar, Neupogen, Pegasys, Perjeta, Pulmozyme, Rocaltrol, Rocephin and Roferon-A. The Company offers products for researchers, including cell analysis, gene expression, genome sequencing and nucleic acid purification.
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