vidofludimus calcium — Topline data
Late 2026
Vidofludimus Calcium in Relapsing MS: Top-line data from the twin Phase 3 ENSURE-1 and ENSURE-2 trials remains on track and is expected to be available by the end of 2026.Source filing
IMUX biotech catalysts & pipeline
IMMUNIC INC · Data as of 2026-09-08
Upcoming catalysts
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