Investor presentation outlines Phase 3 multiple sclerosis program
Immunic positioned vidofludimus calcium (IMU-838) as its lead oral multiple sclerosis candidate, combining Nurr1 activation with selective DHODH inhibition.
Phase 3 ENSURE-1 and ENSURE-2 relapsing MS trials fully enrolled with 2,221 patients; top-line data expected by year-end 2026.
U.S. NDA submission targeted for mid-2027; potential U.S. regulatory approval projected in 2028.
Progressive MS expansion framed around Phase 2 CALLIPER signals on disability measures; Phase 3 program described as in preparation for later in 2026.
Funding expected into late 2027; U.S. intellectual property protection expected through 2044.
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