VarmX and Rentschler Biopharma partner to advance novel coagulation therapy toward Phase 3 and commercialization

January 8, 2026 |

6 min read

Buffer Media Station

Production Line 3

VarmX and Rentschler Biopharma expand collaboration from early development to late‑stage and commercial manufacturing of VMX-C001
VMX‑C001 builds on strong regulatory momentum, including FDA Fast Track Designation and PMDA Phase 1 waiver, as it progresses toward a global Phase 3 trial
Manufacturing will be transferred from Rentschler Biopharma site in Laupheim (Germany) to Milford, MA (USA)

LAUPHEIM, Germany and LEIDEN, The Netherlands and MILFORD, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Rentschler Biopharma, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, and VarmX, a biotech company developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and treatment of inherited coagulation disorders, today announced a collaboration to 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 Biopharma. Building on the successful collaboration between both companies, all subsequent Phase 3 clinical supply, including process validation, will be manufactured at Rentschler Biopharma’s Milford, MA site as part of the seamless transition into late-stage clinical and commercial production. The CDMO brings strong expertise in producing a variety of biologics, including proven capabilities in intensified, perfusion-based processes, while also supporting fed-batch strategies. Rentschler Biopharma provides clients with continuity, speed and reliability from early development through commercialization and beyond.

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. The product candidate was granted Fast Track Designation by the U.S. Food & Drug Administration (FDA) and a Phase 1 waiver from Japanese regulator PMDA in September 2025, recognizing the unmet need for treatments that can rapidly restore coagulation in patients receiving FXa DOACs. 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.

John Glasspool, Chief Executive Officer of VarmX, said: “Manufacturing readiness is key as we prepare to commence our landmark global EquilibriX-S Phase 3 trial, evaluating the ability of VMX-C001 to rapidly restore coagulation in patients taking any FXa DOAC undergoing urgent surgery. We’re pleased to extend our partnership with Rentschler Biopharma as we drive VMX-C001 towards becoming a new treatment option for the substantial number of patients on FXa DOACs who need emergency surgery.”

Benedikt von Braunmühl, Chief Executive Officer of Rentschler Biopharma, commented: “We are honored to continue our collaboration with VarmX, which reflects exactly what Rentschler Biopharma stands for: high‑impact technical expertise, long‑term partnership grounded in trust, and tailored solutions that bring breakthrough therapies to patients. As VMX‑C001 advances toward Phase 3, we remain fully committed to delivering seamless continuity, leveraging our FDA‑licensed sites in the EU and the U.S. and deep experience in late‑stage development and market approval. Guided by our vision of advancing medicine to save lives – together, we look forward to supporting VarmX on the path to commercialization.”

By 2030, approximately 30 million patients in the U.S., 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 30,000 of these patients experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge¹.

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 no additional thrombotic risk. This 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.

^{1: RBC and Cowen (2018–2024), Syneos Health Consulting (incl. Japan), and clinical literature}

About Rentschler Biopharma SE

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with operations in Milford, MA, USA. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma's focus on sustainability. For further information about the company, please visit www.rentschler-biopharma.com. Follow Rentschler Biopharma on LinkedIn.

About VarmX

VarmX is a spin-off from the Leiden University Medical Center (LUMC), founded in 2016 by Professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. VarmX’s lead compound VMX-C001 is a modified recombinant blood factor X. The compound is being developed for the treatment of severe spontaneous bleeding and for the prevention of bleeding during urgent surgery in patients taking oral factor Xa inhibitors (FXa DOACs) as anticoagulation therapy. The Company is supported by a strong syndicate of investors including Sound Bioventures, EIC, EQT Life Sciences (formerly LSP), Inkef, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures and InnovationQuarter, as well as CSL. For more information, please visit www.varmx.com.

Information for media: Rentschler Biopharma’s CEO, Benedikt von Braunmühl, and VarmX’s CEO, John Glasspool, both will attend JP Morgan Week which will take place January 12–15, 2026 in San Francisco, CA, and are open to interview requests.

For inquiries, please contact Laurie Doyle (MC Services AG, laurie.doyle@mc-services.eu).

Contact:

Rentschler Biopharma SE
Dr. Latika Bhonsle-Deeng
Global Head of Communications
Phone: +49-7392-701-467
communications@rentschler-biopharma.com

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