DNTH 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-04

• Our development candidate, DNTH312, is an internally developed, investigational, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of active C1s (“aC1s”) and BAFF/APRIL. DNTH312 is enhanced with YTE half-life extension technology,…

• 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. In June 2026, we announced a 75% …

• (“DIL”), no related serious adverse events (“SAE”) or discontinuations due to safety. We expect to provide CAPTIVATE Part B top-line guidance by the end of 2026.

• Claseprubart is also being evaluated in the Phase 2 MoMeNtum trial for patients with MMN. In August 2026, we announced the completion of enrollment of the MoMeNtum trial, which exceeded its enrollment target of 36 patients, and top-line results with 46 patients are expected in December 2026.

• The EMERGE trial is a global, randomized, multicenter, placebo-controlled Phase 3 trial of claseprubart in approximately 195 AChR+ participants with gMG. Following an initial loading dose, claseprubart 300mg/2mL will be administered Q2W or Q4W via S.C. injection. The primary endpoint of this trial i…

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• 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…

• Claseprubart is also being evaluated in the Phase 2 MoMeNtum trial for patients with MMN, and we anticipate initial top-line results from this trial will be available in the fourth quarter of 2026.

• Based on the outcome of our end-of-Phase 2 meeting with the FDA held in the first quarter of 2026, we expect to initiate a registrational Phase 3 trial of claseprubart evaluating 300mg Q2W and 300mg Q4W in gMG patients in mid-2026 and report top-line results in the second half of 2028.

• On March 10, 2026, we entered into an underwriting agreement with certain underwriters to issue and sell 8,470,989 shares of our common stock, including the full exercise by the underwriters of their option to purchase an additional 1,157,407 shares, at a public offering price of $81.00 per share an…

• The pre-funded warrants are exercisable at any time after the date of issuance. A holder of the pre-funded warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 4.99% of the number of shares of common stock outstanding immediately after g…