• Designation recognises potential of VMX-C001 to address an unmet need in the restoration of coagulation to enable hemostasis in patients receiving a Factor Xa direct oral anticoagulant who require urgent surgery, including surgery for bleeding, with or without the administration of heparin
• Fast Track status aims to expedite review of drugs addressing serious conditions and unmet medical needs
• Has potential to shorten time to market by allowing more frequent interactions with the FDA, a rolling review and potential eligibility for accelerated approval and priority review, enabling quicker market access for patients

Leiden, The Netherlands, 3 September 2025 – VarmX, a biotech company developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and inherited coagulation disorders, announces that lead asset VMX-C001 has been granted Fast Track Designation by the U.S. FDA.

Fast Track Designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening diseases or conditions, which demonstrate the potential to address a critical unmet medical need. The designation offers VarmX the opportunity for more frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data to support marketing approval. It also offers the potential for a rolling review of Varmx’s Biologics License Application (BLA) and for more rapid BLA assessment (via Priority Review) to enable quicker market access for patients.

This news follows VarmX’s announcement in July 2025, confirming that the FDA had cleared its Investigational New Drug (IND) application for VMX-C001, enabling the initiation of EquilibriX-S, a global Phase 3 trial in urgent surgery. EquilibriX-S is a landmark clinical trial evaluating the ability of a FXa DOAC bypassing agent to rapidly and durably restore coagulation in patients taking any FXa DOAC undergoing urgent surgery.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       

VMX-C001 is a modified, human, factor X protein, designed to be insensitive to FXa DOACs, effectively bypassing their anticoagulant activity and swiftly restoring the coagulation cascade.VMX-C001 has been developed with significant clinical advantages, including universal dosing regardless of the specific FXa DOAC used, rapid and easy administration, compatibility with common anticoagulants like heparin, and crucially, no additional thrombotic risk.

By 2030, approximately 30 million patients in the US, Europe and Japan are expected to receive FXa DOACs as a chronic anticoagulation therapy, including stroke prevention in atrial fibrillation and the prevention of deep vein thrombosis. Each week, more than 25,000 of these patients experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge.

John Glasspool, CEO of VarmX, said: 

“Receiving FDA Fast Track Designation is a strong recognition of the real unmet need for treatments that can rapidly restore coagulation to enable urgent surgery in patients on Factor Xa direct oral anticoagulants, as well as the potential of our novel bypass agent approach.

“This FDA Fast Track Designation significantly strengthens the position of VMX-C001 to potentially become a new option for the substantial number of patients on FXa DOACs who need emergency surgery.”