
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)
- FDA approved expanded indication for Takeda’s Vonvendi (recombinant von Willebrand factor) to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with Type 1 and 2 Von Willebrand Disease (VWD) and on-demand and perioperative management of bleeding in paediatric patients with VWD (8 Sep)
- VarmX received the FDA Fast Track Designation for VMX-C001, a modified human Factor X designed to be insensitive to FXa DOACs (direct oral anticoagulants) (9 Sep)
- FDA granted 510(k) clearance to Hemosonics’ Quantra Hemostasis System with QStat Cartridge expanding its use to obstetric procedures (26 Sep)
CLINICAL
- VarmX received the FDA IND approval for the Phase 3 EquilibriX-S trial evaluating the ability of VMX-C001 a (a modified human Factor X insensitive to FXa DOAC) to restore coagulation in patients taking any FXa DOACs and undergoing urgent surgery (8 Jul)
- 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)
- CRISPR Therapeutics and Sirius Therapeutics announced the first participant dosed in Phase 2 trial of SRSD107 (long-acting Factor XI siRNA) for thromboembolic disorders in Europe (23 Sep)
- Japanese PMDA waived the requirement for a Phase 1 ethnic bridging study for VarmX’s VMX-C001 (a modified human Factor X insensitive to FXa DOAC), enabling it to proceed directly to include Japanese participants in its global Phase 3 EquilibriX-S trial (25 Sep)
COMMERCIAL
- CSL entered a strategic collaboration with VarmX to support the late-stage clinical development of VarmX’s VMX-C001 (a modified human Factor X insensitive to FXa DOAC) alongside an exclusive option agreement, dependent on Phase 3 data (16 Sep)
- Cadrenal Therapeutics announced the acquisition of eXIthera Pharmaceuticals, including its proprietary portfolio of investigational intravenous (IV) and oral Factor XIa inhibitors (16 Sep)