Claseprubart (DNTH103) - (EMERGE)

June 29, 2026: Dianthus Therapeutics, Inc. (NASDAQ: DNTH) announced initiation of the Phase 3 EMERGE trial evaluating claseprubart (DNTH103) in acetylcholine receptor antibody–positive (AChR+) generalized myasthenia gravis (gMG). EMERGE is a global, randomized, multicenter, placebo-controlled study (~195 participants) testing claseprubart 300 mg/2 mL subcutaneous dosing every 2 weeks (Q2W) or every 4 weeks (Q4W) versus placebo after a loading dose. The primary endpoint is change from baseline in MG-ADL versus placebo; secondary measures include QMG, Minimal Symptom Expression, MGC, and MG-QoL-15r. Top-line results are expected in 2H 2028.

The release references Phase 2 MaGic trial results (reported Sept 2025; presented at the MGFA Scientific Session during the 2025 AANEM Annual Meeting), where claseprubart 300 mg/2 mL Q2W showed statistically significant, clinically meaningful improvements versus placebo on MG-ADL and QMG (including Week 1 and Week 13) and was generally well tolerated with no drug-related serious AEs or discontinuations.

Regulatory: claseprubart received FDA Orphan Drug Designation for myasthenia gravis in May 2026.

Upcoming catalysts: Phase 2 MoMeNtum trial top-line data in multifocal motor neuropathy (Q4 2026); update on timing for top-line data from Part B of Phase 3 CAPTIVATE in CIDP by year-end 2026.