Dianthus Therapeutics reports that in the first quarter of 2026 it proposed, and in March 2026 received, written FDA agreement to three changes across all ongoing and planned claseprubart trials. Anti-nuclear antibodies will no longer be used as a screening criterion or routinely tested, and the hypothetical safety risk is reclassified from systemic lupus erythematosus to drug-induced lupus. The company notes there have been no cases of SLE or DIL in any claseprubart program to date.
Dianthus’ investor presentation highlights claseprubart and DNTH212 as pipeline-in-a-product autoimmune therapies, with strong Phase 2 gMG data, an early Phase 3 CIDP “GO” decision, and broad neuromuscular and autoimmune indications under study. The company cites a strong financial position with approximately $1.2 billion of pro forma cash and runway expected into 2030, supporting multiple planned milestones, including a Phase 3 gMG trial initiation, Phase 2 MMN data, CAPTIVATE Part B readout guidance in CIDP, and Phase 1 top-line results for DNTH212.
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