Haemostasis January & February 2025 News
Our round-up of the latest developments from across the haemostasis industry for January & February 2025.
REGULATORY
- Star Therapeutics’ VGA039 (Protein S mAb) granted FDA Fast Track designation for the treatment of Von Willebrand disease (VWD) (7 Jan)
CLINICAL
- PharmaEssentia announced positive topline Ph3 data from SURPASS-ET study evaluating Ropeginterferon Alfa-2b-njft (P1101) for Essential Thrombocythemia (6 Jan)
- Anthos Therapeutics announced NEJM publication, showing that abelacimab (Factor XI inhibitor) reduced major or clinically relevant non-major bleeding by 62% compared to rivaroxaban (Xarelto) in patients with atrial fibrillation (22 Jan)
- Novo Nordisk presented interim data from FRONTIER3 Ph 3 trial, demonstrating that Mim8 (Factor VIIIa mimetic bispecific Ab) is well-tolerated and efficacious in children with haemophilia A with and without inhibitors (HA/HAwI) (7 Feb)
- Hemab Therapeutics presented interim data from the ongoing evaluation of HMB-001, a novel FactorVIIa / TLT-1 bispecific antibody in development as first ever prophylactic treatment for the bleeding disorder Glanzmann thrombasthenia (7 Feb)
- CSL Behring announced the four-year results from the HOPE-B Ph3 trial confirming the long-term durability and safety of a one-time infusion of HEMGENIX (etranacogene dezaparvovec-drlb gene therapy) for adults living with haemophilia B (7 Feb)
- TAHO Pharmaceuticals announced positive preliminary results from the Ph2 trial of TAH3311, the first Apixaban oral dissolving film (ODF), demonstrating that TAH3311 is bioequivalent to US and European reference Apixaban tablets (Eliquis) under fasting conditions (17 Feb)
COMMERCIAL
- Novartis entered into agreement to acquire Anthos Therapeutics, gaining abelacimab, a potential first-in-class mAb targeting the FXI inhibition pathway in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation (17 Feb)
- Pfizer announced it will cease development and commercialisation of Beqvez, haemophilia B gene therapy across all of the global markets, highlighting limited interest from patients and doctors (20 Feb)
