Dianthus Therapeutics, Inc. posted an updated corporate presentation on its website and disclosed FDA agreement to proposed changes in screening criteria and safety risk descriptions for ongoing and planned claseprubart trials, including removal of ANA testing and reclassification of SLE risk to DIL, with no cases observed to date.
Key takeaways
Posted updated Corporate Presentation (Exhibit 99.1) on March 26, 2026
FDA agreed in March 2026 to remove ANAs as screening criteria for all claseprubart programs
FDA agreed to remove routine ANA testing during claseprubart clinical trials
FDA agreed to reclassify hypothetical SLE risk to drug-induced lupus (DIL)
No cases of SLE or DIL observed in any claseprubart program to date
Cash position ~$1.2B pro forma including ~$676M from March 2026 follow-on offering