---
schema_version: "secwatch.filing_event.v1"
accession: "0001193805-24-001257"
form_type: "8-K"
ticker: "IMUX"
cik: "0001280776"
company_name: "IMMUNIC, INC."
filed_at: "2024-10-22T23:59:59+00:00"
generated_at: "2026-05-30T11:30:31.324172+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Immunic: IDMC confirms Phase 3 ENSURE trials not futile, recommends continue as planned; CALLIPER data April 2025

## Summary
- IDMC recommended ENSURE-1 and ENSURE-2 continue unchanged; predetermined futility criteria not met.
- Sample size deemed appropriate to address primary endpoint of time to first relapse; no upsizing needed.
- Top-line data from Phase 2 CALLIPER trial in progressive MS expected April 2025.
- ENSURE program completion on track: ENSURE-1 in Q2 2026, ENSURE-2 in H2 2026.
- Immunic remains blinded; drug vidofludimus calcium is a Nurr1 activator for relapsing MS.

## SEC filing metadata
- accession: 0001193805-24-001257
- form_type: 8-K
- ticker: IMUX
- cik: 0001280776
- company_name: IMMUNIC, INC.
- filed_at: 2024-10-22T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1280776/000119380524001257/0001193805-24-001257-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1280776/000119380524001257/e663960_8k-immunic.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193805-24-001257
- JSON: https://secwatch.observer/filing/0001193805-24-001257.json
- Plain text: https://secwatch.observer/filing/0001193805-24-001257.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.