secwatch / observer

8-K filed May 28, 2026, 7:01 AM ET ticker IMUX CIK 0001280776

other material confidence high sentiment neutral materiality 0.60

Immunic presents additional Phase 2 CALLIPER data for vidofludimus calcium in progressive MS at CMSC 2026

IMMUNIC, INC.

Late-breaking poster introduces novel unified endpoint Confirmed Disability Change (CDC) that consistently favored vidofludimus calcium over placebo across three statistical models.
Patient-reported outcomes (PHQ-9) showed no worsening of depressive or suicidal thoughts; treatment satisfaction numerically favored drug over placebo at weeks 48 and 120.
Safety data from 467 patients: TEAEs comparable (69.4% vs 68.5%), discontinuation due to TEAEs identical at 2.6% in both arms; no Hy's law cases.
Serious adverse events low and balanced (8.1% vs 6.5%); liver-related TEAEs similar (5.2% vs 5.5%).

item 7.01 item 9.01

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001193805-26-000703
form_type: 8-K
ticker: IMUX
cik: 0001280776
company_name: IMMUNIC, INC.
filed_at: 2026-05-28T11:01:07+00:00
discovered_at: 2026-05-28T11:05:00.239081+00:00
generated_at: 2026-05-28T11:07:22.487522+00:00
sec_items: ["7.01", "9.01"]
event_type: other_material
sentiment: neutral
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: high
secwatch_canonical_url: https://secwatch.observer/filing/0001193805-26-000703
json_url: https://secwatch.observer/filing/0001193805-26-000703.json
markdown_url: https://secwatch.observer/filing/0001193805-26-000703.md
text_url: https://secwatch.observer/filing/0001193805-26-000703.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1280776/000119380526000703/0001193805-26-000703-index.htm
edgar_primary_document_url: https://www.sec.gov/Archives/edgar/data/1280776/000119380526000703/e665514_8k-immunic.htm
generated_by_model: deepseek-v4-flash:cloud@v2
review_status: machine_generated
human_reviewed: false
corrected: false
correction_note: null
correction_timestamp: null
superseded_by: null

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