Haemostasis News Q1 2026
Our round-up of the latest developments from across the haemostasis industry for Q1 2026.
REGULATORY
- FDA approved a new 2-gram presentation of Octapharma’s Fibryga (lyophilised human fibrinogen) for fibrinogen replacement in patients with acquired fibrinogen deficiency (AFD), building on its FDA approval in 2024 for a 1-gram presentation with nextaro reconstitution device (7 Jan)
CLINICAL
- Metagenomi announced corporate name to Metagenomi Therapeutics and highlighted recent and upcoming business milestones, including plans for IND/STA submissions in Q4 2026 to advance MGX-001 (Factor VIII gene therapy) in first-in-human study in haemophilia A in 2027 (13 Jan)
COMMERCIAL
- VarmX and Rentschler Biopharma expanded collaboration from early development to late‑stage and commercial manufacturing of VMX-C001 (a modified human Factor X insensitive to FXa DOAC), highlighting plans to initiate the global Phase 3 trial in urgent surgery in early 2026 (8 Jan)
- Sysmex America expanded CN-Series with CN-9000 Automated Haemostasis solution for continuous sample loading and automated rerun / reflex testing (21 Jan)
