Earnings summaries and quarterly performance for Dianthus Therapeutics, Inc. /DE/.
Executive leadership at Dianthus Therapeutics, Inc. /DE/.
Board of directors at Dianthus Therapeutics, Inc. /DE/.
Research analysts covering Dianthus Therapeutics, Inc. /DE/.
Recent press releases and 8-K filings for DNTH.
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.
4 days ago
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.
4 days ago
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.
4 days ago
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.
4 days ago
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
Dianthus Therapeutics Provides Pipeline Updates and Financial Outlook
DNTH
Guidance Update
New Projects/Investments
- Dianthus Therapeutics reported a cash balance of $525 million, providing a runway into 2028, following a $288 million raise.
- For Claseprubart, the company plans to start its Phase 3 program for Myasthenia Gravis (MG) in 2026 and has moved up the Phase 3 interim responder analysis for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to Q2 2026. Top-line results for the MMN Phase 2 study are expected in H2 2026.
- Dianthus also licensed DNTH212, a bifunctional fusion protein targeting both innate and adaptive immune systems, with a Phase 1 single-dose study in healthy volunteers starting imminently and results expected in H2 2026.
Nov 17, 2025, 1:30 PM
Dianthus Therapeutics updates on Claseprubart clinical programs and financial runway
DNTH
New Projects/Investments
Guidance Update
- Dianthus Therapeutics' lead program, Claseprubart, a C1s inhibitor, showed exciting Phase 2 Myasthenia Gravis (MG) data in September, validating its potential for best-in-class efficacy with an improved safety profile and infrequent sub-Q auto-injector dosing. The company plans to move to Phase 3 testing Q2 and Q4 week dosing for MG.
- For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), the interim responder analysis for the single Phase 3 trial has been moved up to Q2 2026. Phase 2 top-line results for Multifocal Motor Neuropathy (MMN) are expected in 2H 2026.
- Dianthus has in-licensed a bifunctional fusion protein (212) from Leeds Biolabs, targeting BDCA2 and BAFF APRIL, with an IND cleared in the U.S. and Phase 1 healthy volunteer results expected in 2H 2026.
- Following a raise on the MG data, Dianthus now has approximately $525 million with a financial runway extending into 2028.
Nov 13, 2025, 7:00 PM
Dianthus Therapeutics Provides Claseprubart Clinical Trial Updates
DNTH
Product Launch
New Projects/Investments
- Dianthus Therapeutics is planning a Phase 3 trial for claseprubart in generalized Myasthenia Gravis (gMG), aiming to include a Q4 week dosing arm in addition to the Q2 week arm, and considering a QMG score above 10 as a screening criterion.
- The company plans to discontinue routine ANA testing in the gMG Phase 3 trial, as the ANA signal observed in Phase 2 did not correlate with clinical symptoms and is considered irrelevant.
- Enrollment for the Captivate study in CIDP is proceeding faster than expected, with interim data now anticipated in Q2 instead of the second half of the year, attributed to a more attractive trial design.
- For the Momentum MMN study, Phase 2 top-line data is expected in the second half of the year, with expectations for similar efficacy to Enjaymo and a clean safety profile.
- Dianthus is working on a sub-Q auto-injector for the loading dose of claseprubart, aiming for a label similar to Dupixent, which would involve multiple sub-Q shots at the start.
Nov 12, 2025, 2:30 PM
Dianthus Provides Clinical Trial Updates for Claseprubart
DNTH
New Projects/Investments
Guidance Update
- Dianthus (DNTH) plans to discuss Q4 week dosing for claseprubart in its gMG Phase 3 trial with the FDA, aiming to add it alongside the Q2 week arm, leveraging the drug's 60-day half-life.
- The company is considering a QMG score above 10 as a screening criterion for the gMG Phase 3 trial to ensure patient comparability to historical trials, which could lead to a "best-in-disease" result for MGADL differentiation.
- The Captivate CIDP study is enrolling faster than expected, with interim data now anticipated in Q2, ahead of the original second-half disclosure, attributed to its attractive trial design including an open-label segment and no washout period.
- For the Momentum MMN Phase 2 study, Dianthus expects similar efficacy to Enjaymo, believing claseprubart to be a more potent classical pathway inhibitor, with top-line data expected in the second half of the year.
- Dianthus is working towards an all sub-Q auto-injector loading dose for claseprubart across indications, aiming for a label similar to Dupixent, and is discussing this strategy with the FDA.
Nov 12, 2025, 2:30 PM
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