secwatch.observer — SEC 8-K summary
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Issuer:     IMMUNIC, INC. (IMUX)
CIK:        0001280776
Form:       8-K
Filed at:   2023-10-10T23:59:59+00:00
Accession:  0001193805-23-001384
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Immunic reports positive Phase 2 CALLIPER interim data: NfL reduced 22.4% vs placebo in PMS
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- Vidofludimus calcium lowered serum NfL by 22.4% vs placebo at 24 weeks in overall PMS (p=0.01 post hoc).
- Non-active SPMS subgroup showed 20.1% NfL reduction; PPMS showed 18.8% reduction.
- GFAP increased 3.7% for drug vs 4.4% for placebo at 24 weeks; 2.7% vs 6.4% at 48 weeks.
- Top-line CALLIPER data expected April 2025; Phase 3 ENSURE interim data late 2024.
- NfL reduction numerically higher than historical Ocrevus data in PPMS (22.4% vs 12.4%).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1280776/000119380523001384/0001193805-23-001384-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1280776/000119380523001384/e618990_8k-immunic.htm
  HTML page:      https://secwatch.observer/filing/0001193805-23-001384

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer