Haemostasis Q4 2025 News

Our round-up of the latest developments from across the haemostasis industry for Q4 2025.

REGULATORY

• TAHO Pharma submitted the New Drug Application to the FDA for TAH3311 (apixaban oral dissolving film), developed on its proprietary Transepithelial Delivery System (1 Oct)
• ADLM (Association for Diagnostics & Laboratory Medicine) released new guidance on coagulation testing in patients taking direct oral anticoagulants (DOACs) (4 Nov)
• City Therapeutics announced submission of Clinical Trial Application to the UK MHRA for CITY-FXI (RNAi therapeutic targeting Factor XI) for the treatment of thromboembolic diseases, with plans to initiate Phase 1 study in 2026 (11 Nov)

CLINICAL

• Basking Biosciences dosed the first patients in Part B of its Phase 2 RAISE trial, evaluating BB-031 (RNA aptamer targeting von Willebrand Factor (vWF)), as a reversible thrombolytic for acute ischemic stroke (23 Oct)
• Star Therapeutics announced presentation of interim Phase 1/2 data on VGA039 (Protein S monoclonal antibody) in von Willebrand disease at 67th ASH Meeting & Exposition (3 Nov)
• Genentech/ Roche announced data presentations across its Haemophilia A portfolio at 67th ASH Meeting & Exposition, including post-marketing data for Hemlibra (emicizumab-kxwh, Factor VIIIa mimetic bispecific antibody), positive Phase 1/2 data on NXT007 (next-generation Factor VIIIA mimetic bispecific antibody), and preclinical data on SPK-8011QQ (next-generation AAV gene therapy) (3 Nov)
• Regeneron presented proof-of-concept Phase 2 data for its investigational Factor XI antibodies: REGN7508Cat (targeting the catalytic domain) and REGN9933A2 (targeting A2 domain) for prevention of blood clotting in patients undergoing total knee replacing surgery at AHA 2025 (8 Nov)

COMMERCIAL

• CSL Behring signed a letter of intent with pan-Canadian pharmaceutical alliance for public reimbursement of HEMGENIX (entranacogene dezaparvovec, Factor IX gene therapy), following its authorisation by Health Canada for routine prophylaxis in adults living with haemophilia B (6 Oct)
• Hemab Therapeutics announced $157 million Series C financing to advance next-generation treatments for underserved bleeding disorders, including progressing HMB-002 (monovalent human antibody targeting vWF’s C-terminal CK domain) towards a registrational study in Von Willebrand disease (27 Oct)
• BioMarin outlined plans to pursue options to divest ROCTAVIAN (valoctocogene roxaparvovec, AAV5 based Factor VIII gene therapy), authorised as a one-time treatment for haemophilia A, having previously narrowed down its commercialisation efforts to the US, Germany, and Italy (28 Oct)