Immunic presents plans for mid-2027 US filing for MS drug vidofludimus calcium
IMUX•Immunic expects December 2026 top-line data from its fully enrolled Phase 3 ENSURE-1 and ENSURE-2 trials. Positive results would support a targeted mid-2027 US regulatory submission, with potential approval in 2028.
1. Trial and filing timeline
Immunic expects top-line data in December 2026 from its fully enrolled Phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing multiple sclerosis. Positive results would support a targeted US regulatory submission in mid-2027, with potential approval in 2028. Its Phase 3 PROTECT-MS trial in progressive multiple sclerosis is expected to enroll its first patient in the first half of 2027, and funding is expected to last into late 2027.
