Dianthus Therapeutics Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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Item 8.01 Other Events.
On March 26, 2026, Dianthus Therapeutics, Inc. (the "Company") posted an updated corporate presentation (the "Presentation") on the investor relations section of its website. The Presentation is filed as Exhibit 99.1 and is incorporated by reference into this Item 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 required routine labs, and the description of the hypothetical autoimmune safety risk across claseprubart clinical trials, based on patient experience to date and scientific consensus from published data:
In March 2026, the Company received written feedback from FDA agreeing to all three of these proposals for all ongoing and planned future claseprubart trials. Of note there have been no cases of either SLE or DIL to date in any claseprubart program.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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Corporate Presentation of Dianthus Therapeutics, Inc., dated March 2026 |
104 |
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Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DIANTHUS THERAPEUTICS, INC. |
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Date: |
March 26, 2026 |
By: |
/s/ Adam M. Veness, Esq. |
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Adam M. Veness, Esq. |