DNTH 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-05

• We are a clinical-stage biotechnology company dedicated to developing potentially best-in-disease therapies for patients living with severe autoimmune diseases. Our lead clinical-stage candidate, claseprubart, is a monoclonal antibody that is purposefully engineered with extended half-life, improved…

• Our second clinical-stage candidate, DNTH212, is a first-in-class and potentially best-in-disease, bifunctional fusion protein that targets plasmacytoid dendritic cell (“pDC”) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By tar…

• We are currently conducting three mid- to late-stage clinical trials with claseprubart in generalized Myasthenia Gravis (“gMG”), Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”), and Multifocal Motor Neuropathy (“MMN”).

• In September 2025, we reported positive top-line results from the Phase 2 MaGic trial of claseprubart for patients with gMG and subsequently held an end-of-Phase 2 meeting with the FDA in the first quarter of 2026. We expect to initiate a Phase 3 registrational trial in gMG in mid-2026 and report to…

• In March 2026, we made an early GO announcement in the interim responder analysis for our Phase 3 CAPTIVATE trial of claseprubart in patients with CIDP due to achieving a target of 20 confirmed responders with less than the planned 40 participants completing Part A. We expect to provide CAPTIVATE Pa…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• We are a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. We believe our lead novel and proprietary monoclonal antibody product candidate, claseprubart, has the potential to address a broad array of compl…

• The MaGic trial is a global, randomized, double-blind, placebo-controlled Phase 2 trial of claseprubart that enrolled 65 acetylcholine receptor positive (“AChR+”) participants with gMG. Following an initial loading dose, claseprubart was administered every two weeks (“Q2W”) via S.C. injection at a d…

• The CAPTIVATE trial is a single, two-part, randomized withdrawal global Phase 3 trial of claseprubart in patients with CIDP. In the open label Part A of this trial, participants will be administered claseprubart with a loading dose followed by 300mg/2mL administered Q2W via S.C. injection for up to …

• The MoMeNtum trial is a global, randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the safety, tolerability, and efficacy of claseprubart in 36 patients with MMN. Following determination of Ig dependency and responsiveness, patients will be randomized to receive placebo …

• Our First and Potentially Best-In-Class Bifunctional BDCA2 and BAFF/APRIL Inhibitor (DNTH212)