8-K - Dianthus Therapeutics, Inc. | StockGist

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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

1Posted updated Corporate Presentation (Exhibit 99.1) on March 26, 2026

2FDA agreed in March 2026 to remove ANAs as screening criteria for all claseprubart programs

3FDA agreed to remove routine ANA testing during claseprubart clinical trials

4FDA agreed to reclassify hypothetical SLE risk to drug-induced lupus (DIL)

5No cases of SLE or DIL observed in any claseprubart program to date

6Cash position ~$1.2B pro forma including ~$676M from March 2026 follow-on offering

Current Report Details

Event Type

Other Event

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

8.01

. In addition, in the first quarter of 2026, the Company proposed to the Food & Drug Administration ("FDA") the following changes to screening criteria and requ

Other Event

9.01

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Corporate Presentation of Dianthus Therapeutics, Inc., dated March 2026 104 Cover P

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1