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Dianthus Therapeutics, Inc. /DE/ (DNTH)

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Earnings summaries and quarterly performance for Dianthus Therapeutics, Inc. /DE/.

Research analysts covering Dianthus Therapeutics, Inc. /DE/.

Recent press releases and 8-K filings for DNTH.

Dianthus Therapeutics Updates on Clinical Programs and Financial Outlook
DNTH
New Projects/Investments
Guidance Update
  • Dianthus Therapeutics is advancing two clinical-stage autoimmune therapeutics: claseprubart and DNTH212.
  • For claseprubart, the company anticipates announcing interim responder analysis for its CIDP Phase 3 Part A in Q2 2026 and top-line results for its MMN Phase 2 in H2 2026. The Phase 3 trial for MG is also expected to commence soon.
  • The second program, DNTH212, has initiated its Phase 1 clinical trial, with healthy volunteer data projected for H2 2026 and data in SLE patients from Part B of Phase 1 expected in 2027.
  • Dianthus Therapeutics reports a cash position of $514 million, which is expected to provide a financial runway well into 2028.
Jan 12, 2026, 11:00 PM
Dianthus Therapeutics Provides Updates on Clinical Programs and Financial Runway
DNTH
New Projects/Investments
Guidance Update
  • Dianthus Therapeutics (DNTH) reported $514 million in cash, providing a runway well into 2028.
  • For Clasibobart, an interim responder analysis for the CIDP Phase 3 trial is expected in early Q2 2026, and top-line results for the MMN Phase 2 trial are anticipated in H2 2026.
  • The company plans to initiate a Phase 3 trial for Clasibobart in Myasthenia Gravis (MG) as soon as possible in 2026, which will include testing both every two-week and every four-week dosing schedules.
  • Dianthus's second clinical program, DNTH212, a bispecific fusion protein, has commenced its Phase 1 clinical trial, with healthy volunteer data expected in H2 2026.
Jan 12, 2026, 11:00 PM
Dianthus Therapeutics Outlines 2026 Milestones and Cash Runway
DNTH
New Projects/Investments
Guidance Update
  • Dianthus Therapeutics is advancing two clinical-stage autoimmune therapeutics, Clasibobart and DNTH212, with several key milestones expected in 2026.
  • For Clasibobart, the interim responder analysis for the Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 3 trial (Part A) is now expected in Q2 2026, and top-line results for the Multifocal Motor Neuropathy (MMN) Phase 2 trial are anticipated in the second half of 2026.
  • The company is in discussions with the FDA regarding the Phase 3 trial design for Myasthenia Gravis (MG), aiming for superior efficacy and a patient-friendly dosing schedule.
  • DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor, has commenced its Phase 1 clinical trial, with healthy volunteer data expected in the second half of 2026.
  • Dianthus Therapeutics reports a strong financial position with approximately $514 million in cash, providing a runway extending well into 2028.
Jan 12, 2026, 11:00 PM
Dianthus Therapeutics, Inc. Provides Financial Update and Announces Positive Phase 2 Results for Claseprubart
DNTH
Guidance Update
New Projects/Investments
  • Dianthus Therapeutics, Inc. expects to report approximately $514 million in cash, cash equivalents, and short-term investments as of December 31, 2025, which is projected to provide a financial runway into 2028. This is a preliminary and unaudited estimate.
  • The company announced positive Phase 2 results for Claseprubart in generalized Myasthenia Gravis (gMG), demonstrating rapid, sustained, and statistically significant symptom improvements and a potentially differentiated safety profile. The target dose of 300mg/2mL Q2W will be advanced to a Phase 3 study.
  • Key upcoming clinical milestones for 2026 include the initiation of a Phase 3 gMG trial for Claseprubart, interim responder analysis for the Phase 3 CIDP trial in Q2 2026, and Phase 2 MMN top-line results in 2H 2026. Additionally, an update on DNTH212 indication prioritization is expected in 1H 2026, with Phase 1 healthy volunteer top-line results in 2H 2026.
Jan 12, 2026, 2:01 PM
Dianthus Therapeutics Highlights De-Risked Profile and Upcoming 2026 Catalysts
DNTH
New Projects/Investments
Guidance Update
  • Dianthus Therapeutics is considered a significantly de-risked company following positive Phase II MG data presented in September, which confirmed the potency and safety of its 300 mg every two weeks dosing for neuromuscular conditions.
  • The company anticipates two key catalysts in 2026: an interim responder analysis for its CIDP trial in Q2 and Phase II top-line data from its MMN trial in the second half. The CIDP trial timelines were accelerated due to quicker patient enrollment.
  • Dianthus has also introduced a new asset, NTH212, a bispecific/bifunctional fusion protein licensed from China, which has potential as a first-in-class and best-in-class product.
  • For its CIDP trial, the company expects to see efficacy competitive with riliprubart, with response rates in the 40%-50% range, and is exploring the potential for every four-week dosing in MG.
Dec 2, 2025, 7:35 PM
Dianthus Therapeutics CEO Discusses De-Risked Pipeline and Upcoming Catalysts
DNTH
New Projects/Investments
Guidance Update
  • Dianthus Therapeutics (DNTH) has been significantly de-risked following positive Phase 2 MG data in September, which confirmed the potency and safety of claseprubart (300 mg every two weeks) for neuromuscular conditions.
  • The company has two significant catalysts in 2026: an interim responder analysis for its CIDP trial in Q2 and Phase 2 top-line data from its MMN trial in H2.
  • Recruitment for the CIDP trial accelerated, leading to earlier timelines, and the company expects its drug to show competitive efficacy to riliprubart with a dosing advantage of one shot every two weeks.
  • Dianthus also licensed NTH 212, a new bispecific/bifunctional fusion protein with potential as a first-in-class or best-in-class asset, with its indication selection disclosure planned before Phase 1 data in H2 2026.
Dec 2, 2025, 7:35 PM
Dianthus Therapeutics Provides Clinical Trial Updates and Future Catalysts
DNTH
New Projects/Investments
Guidance Update
  • Dianthus Therapeutics considers itself significantly de-risked following the positive Phase 2 Myasthenia Gravis (MG) data presented in September, which confirmed the potency and safety of claseprubart.
  • The company anticipates two significant catalysts in 2026: an interim responder analysis for its CIDP trial in Q2 2026 and Phase 2 top-line data from its MMN trial in H2 2026.
  • For the CIDP interim analysis, Dianthus expects to demonstrate efficacy competitive with riliprubart, aiming for a 40-50% responder rate with a one-shot every two-week dosing advantage.
  • Dianthus has also licensed NTH 212, a new bispecific fusion protein from China, which is considered a potential first-in-class or best-in-class product.
Dec 2, 2025, 7:35 PM
Dianthus Therapeutics Provides Updates on Clinical Trials and New Asset
DNTH
New Projects/Investments
Guidance Update
  • Dianthus Therapeutics confirmed the potency and safety of its 300 mg every two weeks dosing for neuromuscular conditions with positive Phase II MG data presented in September.
  • The company expects two key catalysts in 2026: an interim responder analysis for its CIDP trial and Phase II top-line data from its MMN trial.
  • Timelines for the CIDP trial were accelerated due to increased recruitment, and the trial design is differentiated by allowing IVIG-refractory patients and no washout period.
  • Dianthus anticipates competitive efficacy for its CIDP trial, similar to rilipibart's 40-50% response rates, with a dosing administration advantage.
  • The company also licensed NTH212, a new bispecific/bifunctional fusion protein, which is considered a potential first-in-class and best-in-class asset, with its indication selection disclosure planned before Phase 1 data in H2 2026.
Dec 2, 2025, 7:35 PM
Dianthus Therapeutics Provides Pipeline and Financial Update at Jefferies Conference
DNTH
Guidance Update
New Projects/Investments
  • Dianthus Therapeutics is advancing a leading autoimmune franchise, Claseprubart and DNTH212, with a focus on infrequent subcutaneous self-administration.
  • The company reported positive Phase II data for Claseprubart in myasthenia gravis (MG) in September and October 2025, with a Phase III program in MG expected to start in 2026.
  • Key upcoming catalysts include the interim responder analysis for Claseprubart's Phase III in CIDP, moved up to Q2 2026, and top-line results for its Phase II in MMN in H2 2026.
  • Dianthus also licensed DNTH212, a bifunctional fusion protein, with a Phase I study in healthy volunteers starting imminently and results expected in H2 2026.
  • Following a $288 million raise, the company has a cash balance of approximately $525 million, providing a runway into 2028.
Nov 17, 2025, 1:30 PM
Dianthus Therapeutics Provides Clinical Development and Financial Updates
DNTH
Guidance Update
New Projects/Investments
  • Dianthus Therapeutics reported a cash balance of approximately $525 million, providing a runway into 2028, following a $288 million raise.
  • The company plans to start its Phase III program for Claseprubart in myasthenia gravis (MG) in 2026, with an imminent FDA meeting to finalize the study design, which is expected to enroll patients over approximately two years.
  • For Claseprubart, the Phase III interim responder analysis for chronic inflammatory demyelinating polyneuropathy (CIDP) has been moved up to Q2 2026, and Phase II top-line results for multifocal motor neuropathy (MMN) are on track for H2 2026.
  • Dianthus Therapeutics is imminently starting a Phase I single-dose study for its new bifunctional fusion protein, DNTH212, with results and an announcement on prioritized indications expected in H2 2026.
Nov 17, 2025, 1:30 PM