Haemostasis Q3 2025 News
Our round-up of the latest developments from across the haemostasis industry for Q3 2025.
REGULATORY
- Novo Nordisk’s Alhemo (concizumab-mtci, a tissue factor pathway inhibitor antagonist) injection received positive opinion by the EMA CHMP, recommending label expansion to include the treatment of severe haemophilia A and moderate or severe haemophilia B without inhibitors (25 Jul)
- Kedrion Biopharma received the FDA Orphan Drug Designation for COAGADEX (a plasma-derived coagulation Factor X concentrate) for acquired Factor X deficiency and initiated clinical trial to evaluate its efficacy and safety (30 Jul)
- FDA approved Novo Nordisk’s Alhemo (concizumab-mtci, a tissue factor pathway inhibitor antagonist) injection as a once-daily prophylaxis in adult and paediatric patients 12 years of age and older with haemophilia A or B without inhibitors, expanding on the December 2024 approval for haemophilia A or B with inhibitors (31 July)
CLINICAL
- Be Bio announced the first participant dosed in BeCoMe-9 trial of BE-101, a potentially first-in-class engineered B Cell Medicines (BCM), enabling continuous expression of active Factor IX for the treatment of haemophilia B (31 Jul)
