Immunic Secures Up to $400M to Advance Vidofludimus Toward MS Market

Immunic raises cash to advance multiple sclerosis candidate toward market

Funding underwrites transition from R&D to commercial-stage for vidofludimus calcium

Immunic, the German-origin biopharma developing oral therapies for immune-mediated diseases, announces a private placement that provides an immediate USD 200 million and the potential for up to USD 400 million in gross proceeds. The company says the financing is designed to fund a strategic transition from an R&D-focused organisation into a commercial-stage company, supporting completion of its ongoing Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis (RMS).

Vidofludimus calcium, which Immunic describes as a first-in-class oral therapy combining selective DHODH inhibition with Nurr1 activation, is positioned to reduce inflammatory damage while enhancing neuronal survival, the company says. Immunic expects top-line data from the ENSURE programme by the end of 2026 and plans a New Drug Application submission in the United States in mid-2027, targeting potential regulatory approval in 2028. Management frames the financing as essential to the pre-commercial ramp-up, allowing the company to scale manufacturing, build inventory and expand medical and commercial teams ahead of potential launch.

The company also plans to initiate a Phase 3 programme in primary progressive multiple sclerosis (PPMS) later this year, which Immunic estimates will take roughly 3.5 to 4 years to complete. The financing is intended to support that PPMS programme alongside regulatory engagement and broader global development activities, positioning Immunic to pursue multiple MS indications and a sustained commercial entry should regulatory milestones be met.

Board moves and CEO search accompany the capital raise

Immunic elevates Simona Skerjanec to interim chairperson of the board and adds Thor Nagel as a director, while launching an executive search for a commercially experienced chief executive officer led by Skerjanec and Dr. Daniel Vitt. The company frames these leadership changes as part of the shift toward commercialization and building a management team with launch experience.

Operational build-out and investor support

Proceeds will also support manufacturing scale-up, pre-commercial inventory build, regulatory interactions and hiring to support potential U.S. commercialisation and global development. The financing is led by existing investor BVF Partners and includes participation from a syndicate of life‑science investors, underpinning institutional support for Immunic’s push toward late-stage clinical readouts and market preparation.