Early GO decision reached in CAPTIVATE in March 2026 based on GO criteria of 20 confirmed responders achieved with less than 40 planned participants completing open-label Part A
Claseprubart granted Orphan Drug Designation by FDA for Myasthenia Gravis
Phase 3 registrational trial of claseprubart evaluating 300mg/2mL Q2W and 300mg/2mL Q4W in generalized Myasthenia Gravis (gMG) on track to initiate in mid-2026; top-line results anticipated in 2H'28
Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results on track for Q4'26
Phase 1 healthy volunteer data for DNTH212 anticipated in 2H'26
Building a rheumatology franchise around DNTH212 with first three priority indications of Sjögren's Disease (SjD), Systemic Lupus Erythematosus $(SLE)$, and Dermatomyositis $(DM)$
Further strengthened the balance sheet with approximately $719 million in gross proceeds from an underwritten public offering of common stock and pre-funded warrants
Approximately $1.2 billion of cash as of March 31, 2026 provides expected runway into 2030
NEW YORK and WALTHAM, Mass., May 05, 2026 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today reported financial results for the first quarter ending March 31, 2026, and provided an update on other recent business achievements.
"Q1 of this year was a pivotal period for Dianthus as we were able to make an early GO decision in PART A of the claseprubart CIDP CAPTIVATE study. In CAPTIVATE, we targeted 40 patients completing Part A and a response rate of approximately 50% based on precedent set with aC1s inhibition. We were able to make an early GO decision after 20 confirmed responders were identified with less than the 40 planned participants completing Part A. Claseprubart potency and early efficacy and safety results in CAPTIVATE Part A further build our confidence in claseprubart as a potentially best-in-disease therapy for neuromuscular diseases," said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. "We are also excited to announce the first three priority indications selected for DNTH212, our first-in-class bifunctional fusion protein and next potential best-in-disease pipeline therapeutic: Sjögren's Disease, Systemic Lupus Erythematosus, and Dermatomyositis. These are areas of high unmet need, where compelling biological rationale and clinical data support the complementary potential of targeting both BDCA2 and BAFF/APRIL to drive differentiated efficacy compared to single-mechanism approaches. Together, these indications represent a strong foundation for establishing a synergistic rheumatology franchise around DNTH212, alongside the synergistic neuromuscular franchise we are building with claseprubart in gMG, CIDP and MMN."
Claseprubart (DNTH103) Clinical Development
Claseprubart is an investigational, clinical-stage, potent monoclonal antibody engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein, a clinically validated complement target. Claseprubart is designed to enable a more convenient, subcutaneous (S.C.), self-administered injection dosed as infrequently as once every two or four weeks. Claseprubart has the potential to be a best-in-disease pipeline-in-a-product across a range of autoimmune disorders with high unmet need.
Generalized Myasthenia Gravis (gMG)
-- Phase 3 EMERGE trial on track to initiate in mid-2026, with top-line
results expected in 2H'28: Following the successful completion of our
end-of-Phase 2 meeting with the FDA in the first quarter of 2026, a Phase
3 registrational trial of claseprubart evaluating 300mg/2mL Q2W S.C. and
300mg/2mL Q4W S.C. in gMG patients is on track to initiate in mid-2026,
with top-line results expected in 2H'28.
-- Orphan Drug Designation granted: Claseprubart was granted Orphan Drug
Designation by the FDA for the treatment of Myasthenia Gravis. The FDA's
Office of Orphan Products Development grants orphan designation to drugs
and biologics intended to treat rare diseases affecting fewer than
200,000 people in the United States. Orphan Drug Designation qualifies
sponsors for incentives including tax credits for qualified clinical
trials, exemption from user fees, and potential seven years of market
exclusivity after approval.
-- Claseprubart data presented at the 2026 American Academy of
Neurology $(AAN)$ Annual Meeting: Two presentations describing results from
the Phase 2 MaGic trial of claseprubart in gMG and in vitro data
supporting the potential mechanistic advantages of aC1s inhibition are
available on the Investors section of the Dianthus website under
Scientific Publications.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
-- Early GO decision announced in Phase 3 CAPTIVATE trial in March 2026: The
target for the Part A interim responder analysis was a response rate of
50% or greater (i.e., >=20 confirmed responders out of first 40
participants to complete Part A) based on precedent set with aC1s
inhibition. This GO decision was reached early, after 20 confirmed
responders were achieved with less than 40 planned participants
completing open-label Part A of the trial. Dianthus expects to provide
CAPTIVATE Part B top-line guidance by YE'26.
Multifocal Motor Neuropathy (MMN)
-- Phase 2 MoMeNtum trial on track for top-line results in Q4'26: The
MoMeNtum trial is an ongoing global, randomized, double-blind,
placebo-controlled Phase 2 trial in patients with MMN, with top-line
results on track for Q4'26.
All Programs
In March 2026, the Company filed an 8K indicating receipt of written feedback from FDA agreeing to three proposals for all ongoing and planned future claseprubart trials:
-- Removal of anti-nuclear antibodies ("ANAs") as a screening criteria, a
common reason for screen failure across all three claseprubart programs;
-- Removal of routine ANA testing during claseprubart clinical trials; and
-- Reclassification of the hypothetical risk of SLE to drug-induced lupus
(DIL), a side effect in several classes of widely used medications
characterized by the reversal of symptoms upon discontinuation of the
precipitating medication.
Of note, there have been no cases of either SLE or DIL to date in any claseprubart program.
DNTH212 Clinical Development
DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes.
-- Initial indications selected for DNTH212 clinical development: SjD, SLE,
and DM have been selected as the first three priority indications for
DNTH212 clinical development and will serve as the foundation of a
synergistic rheumatology franchise for DNTH212.
-- Phase 1 data anticipated in 2H'26: A two-part Phase 1 study in China in
healthy volunteers (Part A) and patients with systemic lupus
erythematosus (Part B) was initiated in December 2025, with top-line
results in healthy volunteers expected in 2H'26. Upon completion of the
Phase 1 study, Dianthus plans to provide an update on next steps for
advancing its priority indications in clinical development.
Corporate Updates:
On March 12, Dianthus announced the closing of an upsized underwritten public offering of common stock and pre-funded warrants, with aggregate gross proceeds of approximately $719 million.
First-Quarter 2026 Financial Results
-- Cash Position -- Approximately $1.2 billion of cash, cash equivalents and
investments as of March 31, 2026 is projected to provide runway into
2030.
-- R&D Expenses -- Research and development (R&D) expenses for the quarter
ended March 31, 2026 were $34.5 million, inclusive of $4.8 million of
stock-based compensation, compared to $27.0 million for the quarter ended
March 31, 2025, which included $2.5 million of stock-based compensation.
This increase in R&D expenses was primarily driven by higher clinical
costs and increased headcount to support claseprubart Phase 2 and Phase 3
development.
-- G&A Expenses -- General and administrative (G&A) expenses for the quarter
ended March 31, 2026 totaled $12.5 million, inclusive of stock-based
compensation of $5.8 million, compared to $7.3 million for the quarter
ended March 31, 2025, which included $2.8 million of stock-based
compensation. This increase in G&A expenses was primarily due to
increased headcount.
-- Net Loss -- Net loss for the quarter ended March 31, 2026 was $40.8
million or $0.85 per share (basic and diluted) compared to $29.5 million
or $0.82 per share (basic and diluted) for the quarter ended March 31,
2025.
-- Additional Information -- For additional information on the Company's
financial results for the quarter ended March 31, 2026, please refer to
the Form 10-Q filed with the SEC.
About Claseprubart (DNTH103)
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