IMUX biotech catalysts & pipeline

IMMUNIC INC · Data as of 2026-10-25

Upcoming catalysts

vidofludimus calcium — Topline data

Late 2026

Together, these findings further support the clinical and scientific rationale for our planned Phase 3 program in progressive MS, which we expect to initiate later this year, while we also approach the top-line results from our fully enrolled Phase 3 ENSURE trials in relapsing MS, expected by year-end 2026.

Source filing

vidofludimus calcium — NDA/BLA submission

mid-2027

If positive, Immunic plans to submit a New Drug Application (NDA) in the United States in mid-2027, with a targeted potential regulatory approval date in 2028.

Source filing

vidofludimus calcium — Regulatory decision

2028

If the ENSURE trials are positive, we intend to target submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration in mid-2027, with potential U.S. regulatory approval in 2028.

Source filing

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