Rentschler Biopharma, a global CDMO for biopharmaceuticals, and VarmX, a biotech company developing direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and treatment of inherited coagulation disorders, entered a collaboration for the manufacture VarmX’s lead program, VMX-C001, for Phase 3 development and potential commercialization.

VMX-C001 is a novel treatment to restore blood coagulation in patients requiring urgent surgery or experiencing severe bleeding while on FXa DOACs.

Rentschler Biopharma began supporting early development of VMX-C001 in 2022 at its Laupheim, Germany site and VarmX has since initiated its Phase 3 program using GMP material from Rentschler. All subsequent Phase 3 clinical supply, including process validation, will be manufactured at Rentschler Biopharma’s Milford, MA site as part of the transition into late-stage clinical and commercial production. 

Rentschler has expertise in producing a variety of biologics, including capabilities in intensified, perfusion-based processes, as well as supporting fed-batch strategies.  

VMX-C001 is a modified, human factor X protein, designed to be insensitive to FXa DOACs, effectively bypassing their anticoagulant activity and restoring the coagulation cascade. The product candidate was granted Fast Track Designation by the U.S. FDA and a Phase 1 waiver from Japanese regulator PMDA in September 2025. VarmX signed a global strategic collaboration and option agreement with CSL in September 2025. VarmX plans to initiate its global Phase 3 EquilibriX-S trial in urgent surgery in early 2026.