secwatch.observer — SEC 8-K summary
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Issuer:     Dianthus Therapeutics, Inc. /DE/ (DNTH)
CIK:        0001690585
Form:       8-K
Filed at:   2026-03-26T23:59:59+00:00
Accession:  0001690585-26-000010
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA agrees to remove ANA screening, reclassify lupus risk for Dianthus' claseprubart trials
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- FDA agreed to remove anti-nuclear antibodies (ANAs) as screening criteria for all ongoing and future claseprubart trials.
- Routine ANA testing during claseprubart trials will be eliminated per FDA feedback.
- Hypothetical risk reclassified from systemic lupus erythematosus (SLE) to drug-induced lupus (DIL), a reversible side effect.
- No cases of SLE or DIL have been observed in any claseprubart program to date.
- Company posted an updated corporate presentation on its website summarizing these changes.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1690585/000169058526000010/0001690585-26-000010-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1690585/000169058526000010/dnth-20260326.htm
  HTML page:      https://secwatch.observer/filing/0001690585-26-000010

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