Dianthus Secures Early Phase 3 CIDP Trial GO Decision, Ends 2025 with $514M Cash
Dianthus achieved an early GO decision in its Phase 3 CAPTIVATE CIDP trial after enrolling 20 confirmed responders with fewer than 40 participants, advancing Part B guidance by year-end. The company closed 2025 with $514.4 million cash runway into 2028 while R&D expenses rose to $145.6 million from $83.1 million in 2024.
1. Early GO Decision in CIDP Trial
Dianthus reported that its Phase 3 CAPTIVATE trial for chronic inflammatory demyelinating polyneuropathy reached the interim responder target early, achieving 20 confirmed responders with fewer than the planned 40 participants in open-label Part A. This milestone initiates Part B top-line guidance by the end of 2026 and validates the 300mg/2mL Q2W and Q4W subcutaneous dosing regimens for claseprubart.
2. Strong Cash Position and Rising R&D Spend
As of December 31, 2025, Dianthus held $514.4 million in cash, equivalents and investments, providing a runway into 2028. Full-year R&D expenses climbed to $145.6 million in 2025 from $83.1 million in 2024, driven by increased clinical costs, DNTH212 development milestones and expanded headcount to support claseprubart trials.
3. Upcoming Clinical Milestones
Dianthus plans to initiate a Phase 3 registrational trial of claseprubart in generalized myasthenia gravis by mid-2026 with top-line results expected in the second half of 2028. The Phase 2 MoMeNtum trial in multifocal motor neuropathy remains on track for 2H 2026 results, while Phase 1 healthy volunteer data for DNTH212 is anticipated in 2H 2026, with an indication prioritization update planned in 1H 2026.