×
Contact Us

Contact Us

Please contact us below with any questions

info@quadratech.co.uk

+44 (0)33 3321 2371

Side Contact
×
Sign up to our newsletter Click Here
quadratech Logo
Next Day & International Delivery
Competitive Pricing
Over 30 Years Experience
Based In The UK
Newspaper with tablet on wooden table

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)

Our Accreditations

Receive Our Latest News
Sign Up To Our Newsletter