---
schema_version: "secwatch.filing_event.v1"
accession: "0001690585-26-000010"
form_type: "8-K"
ticker: "DNTH"
cik: "0001690585"
company_name: "Dianthus Therapeutics, Inc. /DE/"
filed_at: "2026-03-26T23:59:59+00:00"
generated_at: "2026-05-15T08:51:01.060356+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA agrees to remove ANA screening, reclassify lupus risk for Dianthus' claseprubart trials

## Summary
- 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.

## SEC filing metadata
- accession: 0001690585-26-000010
- form_type: 8-K
- ticker: DNTH
- cik: 0001690585
- company_name: Dianthus Therapeutics, Inc. /DE/
- filed_at: 2026-03-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1690585/000169058526000010/0001690585-26-000010-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1690585/000169058526000010/dnth-20260326.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001690585-26-000010
- JSON: https://secwatch.observer/filing/0001690585-26-000010.json
- Plain text: https://secwatch.observer/filing/0001690585-26-000010.txt

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