Dianthus wins FDA approval to remove lupus screening from claseprubart trials

Filed March 26, 2026 · Period ending March 26, 2026 · ~1 min read

Key Changes

• high

  FDA approved removal of anti-nuclear antibody (ANA) screening requirements for all claseprubart trials, eliminating a common reason for patient screen failures and streamlining enrollment.

  Item 8.01 verify on EDGAR →
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  FDA agreed to reclassify hypothetical lupus risk from systemic lupus to reversible drug-induced lupus and eliminate routine ANA testing during trials, reflecting accumulated safety data.

  Item 8.01 verify on EDGAR →
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  Company disclosed zero cases of systemic lupus or drug-induced lupus across all claseprubart programs to date, supporting the FDA's decision to relax safety monitoring requirements.

  Item 8.01 verify on EDGAR →