Haemostasis Q2 2025 News
Our round-up of the latest developments from across the haemostasis industry for Q2 2025, including the latest data presentations at ISTH 2025.
REGULATORY
- FDA approved Bayer’s Jivi (a recombinant extended half-life factor VIII concentrate) for use in paediatric patients 7 years of age and older with haemophilia A based on Alfa-PROTECT and PROTECT Kids trial data, expanding its eligibility to paediatric patients aged between 7 and 12 years old (19 May)
- Sysmex received Health Canada license for the CN Series automated blood coagulation analysers CN-3000 & CN-6000 (26 Jun) and the FDA clearance for the CN-6000 analyser (26 Jun)
CLINICAL
- Pfizer’s Beqvez (fidanacogene elaparvovec, AAV-based FIX gene therapy) featured in NEJM publication demonstrating its long-term efficacy and safety in patients with Haemophilia B followed up for a period of 3 to 6 years (9 Apr), but has been discontinued by the company in Feb 2025
- Novo Nordisk announced new haemophilia data presentations at ISTH 2025, including FRONTIER5 Ph3 analysis evaluating the safety of switching directly from emicizumab (FVIII mimetic bispecific antibody) to Mim8 (denecimig, FVIII mimetic bispecific antibody with monovalent anti-FIXa arm) in people living with haemophilia A/B (23 Jun)
- Roche / Chugai announced positive Ph1/2 data for NXT007 (FVIII mimetic bispecific antibody) in people with haemophilia A, supporting its progression into Ph3 clinical development planned for 2026 (23 Jun)
- BioMarin presented at ISTH 2025 5-year GENEr8-1 Ph3 data reinforcing long-term efficacy and safety of Roctavian (valoctocogene roxaparvovec-rvox, AAV-based FVIII gene therapy), with 81.3% of individuals with haemophilia A remaining off prophylaxis (24 Jun)
- Hemab Therapeutics presented Ph2 interim data on sutacimig (Factor VIIa /TLT-1 bispecific antibody) demonstrating >50% reduction in treated bleeding event and prophylactic treatment potential in Glanzmann thrombasthenia at ISTH 2025 (25 Jun)
- Hemab Therapeutics also presented data from first-in-human VELORA trial of HMB-002 (monovalent antibody targeting CK domain of Von Willebrand Factor), demonstrating clinical proof-of-mechanism as prophylactic therapy in Type 1 Von Willebrand disease at ISTH 2025 (25 Jun)
- Pfizer announced that Ph3 BASIS trial of Hympavzi (TFPI monoclonal antibody) in haemophilia A or B with inhibitors met its primary and key secondary bleeding endpoints demonstrating the superiority of once-weekly vs. on-demand treatment, and plans to discuss the data with regulatory authorities (26 Jun)
COMMERCIAL
- Novartis completed its acquisition of Anthos Therapeutics in a transaction valued at up to $3.1 billion, regaining global exclusive rights to abelacimab (novel Factor XI inhibitor), in Ph3 clinical development for the prevention of stroke and systemic embolism in atrial fibrillation or cancer-associated thrombosis (4 Apr)
- CRISPR Therapeutics and Sirius Therapeutics entered a strategic partnership to co-develop and co-commercialise novel siRNA therapies, including SRSD107, a long-acting Factor XI small interfering RNA (siRNA), for the treatment of thromboembolic disorders (20 May)
