Core Insights - Dianthus Therapeutics reported significant advancements in the clinical development of claseprubart, particularly in the Phase 2 MaGic trial for generalized Myasthenia Gravis (gMG), showing statistically significant improvements in MG-ADL and QMG scores at Week 13 [1][4][5] - The company has accelerated the timeline for the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to Q2 2026 due to faster enrollment [1][6] - An exclusive licensing agreement for DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor, was announced, with Phase 1 data expected in 2H 2026 [1][8][12] - Dianthus has an estimated cash position of approximately $525 million, providing financial runway into 2028 [1][18] Clinical Development Updates - Claseprubart demonstrated rapid and clinically meaningful improvements in gMG patients, with the 300mg/2mL Q2W dose showing significant efficacy across multiple endpoints [4][5] - The Phase 3 trial for claseprubart in gMG is anticipated to begin in 2026, with a focus on both 300mg/2mL Q2W and Q4W dosing [1][11] - The ongoing Phase 2 MoMeNtum trial for Multifocal Motor Neuropathy (MMN) is expected to yield top-line results in 2H 2026 [1][7] Financial Performance - For Q3 2025, Dianthus reported a net loss of $36.8 million, or $0.97 per share, compared to a net loss of $25.2 million, or $0.74 per share, in Q3 2024 [10][24] - Research and development expenses increased to $32.5 million in Q3 2025, driven by higher clinical costs and increased headcount [10][18] - General and administrative expenses rose to $8.2 million in Q3 2025, reflecting increased staffing [10][18] Corporate Strategy - The company aims to establish itself as a leader in the autoimmune disease treatment space, focusing on delivering best-in-class therapies with infrequent, subcutaneous self-administration [2][3] - The CEO emphasized the importance of executing their plans to advance both claseprubart and DNTH212 as transformative therapies for severe autoimmune diseases [2][3]
Dianthus Therapeutics Highlights Recent Business Achievements and Reports Q3 Financial Results