Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Vidofludimus calcium (IMU-838) in Multiple sclerosis, Autoimmune disease. The expected timing is based on the latest available company guidance and may change.
ENSURE-1/-2 trials. 8/8/24- Interim futility analysis in Q4 2024. 10/22/24- Positive outcome of interim futility analysis. Trial to proceed w/out changes. 3/31/25- Completion of first trials in Q2 2026 and the second trial in H2 2026. 6/5/25- Enrollment complete in both trials; topline data in YE 2026 11/13/25:- ENSURE-1/-2 Ph3 RMS topline data remains expected by YE 2026. 02/26/26:- ENSURE-1/-2 Ph3 RMS topline data reiterated for YE 2026; NDA mid-2027, potential approval 2028. 05/13/26:- ENSURE-1/-2 Ph3 RMS topline data, NDA mid-2027, and potential 2028 approval timelines reiterated. 08/11/26:- ENSURE-1/-2 Ph3 RMS topline data, NDA mid-2027, and 2028 approval timelines reiterated.
Verification
Confirm timing and program details against the company announcement or filing.