secwatch.observer — SEC 8-K summary
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Issuer:     Dianthus Therapeutics, Inc. /DE/ (DNTH)
CIK:        0001690585
Form:       8-K
Filed at:   2025-09-08T23:59:59+00:00
Accession:  0001193125-25-197751
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Dianthus reports positive Phase 2 MaGic trial for claseprubart in gMG; both doses meet endpoints
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- Claseprubart 300mg Q2W: MG-ADL mean change -4.6 (placebo-adjusted -1.8, p=0.0113); QMG -4.4 (adj. -2.4, p=0.0144) at Week 13.
- Claseprubart 600mg Q2W: MG-ADL mean change -5.4 (adj. -2.6, p=0.0006); QMG -4.5 (adj. -2.5, p=0.0111).
- Rapid onset: both doses showed stat. significant MG-ADL and QMG improvement as early as Week 1.
- Favorable safety: no related serious infections, SAEs, or discontinuations; no Boxed Warning or REMS anticipated for planned autoinjector.
- Phase 3 gMG trial evaluating 300mg Q2W and Q4W vs placebo planned to start in 2026; CIDP and MMN data expected 2H 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1690585/000119312525197751/0001193125-25-197751-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1690585/000119312525197751/d933929d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-197751

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