Dianthus Therapeutics, Inc. /DE/
For the period ended Aug 4, 2026. Filed Aug 4, 2026.
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Aug 4, 2026 · Filed Aug 4, 2026
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Contents
EX-99.1 · All Programs
All Programs
Claseprubart presentations at the American Academy of Neurology (AAN), Peripheral Nerve Society (PNS), and European Academy of Neurology (EAN) meetings described the design of the pivotal Phase 3 CAPTIVATE study in CIDP, Phase 2 MaGic trial results in gMG, Minimal Symptom Expression (MSE) results for claseprubart from MaGic, and potential mechanistic advantages of targeting aC1s in gMG. Presentations are available in the Investors section of the Dianthus website.
In March 2026, the Company filed an 8K indicating receipt of written feedback from FDA agreeing to three proposals for all ongoing and planned future claseprubart trials:
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Removal of anti-nuclear antibodies ("ANAs") as a screening criteria, a common reason for screen failure across all three claseprubart programs;
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Removal of routine ANA testing during claseprubart clinical trials; and
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Reclassification of the hypothetical risk of SLE to drug-induced lupus (DIL), a side effect in several classes of widely used medications characterized by the reversal of symptoms upon discontinuation of the precipitating medication.
Of note, there have been no cases of either SLE or DIL to date in any claseprubart program.
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