Dianthus posts positive Phase 2 gMG trial data

Dianthus Therapeutics announced positive top-line results from its Phase 2 MaGic trial of claseprubart (DNTH103) in adults with acetylcholine receptor antibody positive generalized myasthenia gravis.

Rhea-AI Filing Summary

Dianthus Therapeutics announced positive top-line results from its Phase 2 MaGic trial of claseprubart (DNTH103) in adults with acetylcholine receptor antibody positive generalized myasthenia gravis. The study evaluated both safety and efficacy of DNTH103 in this autoimmune neuromuscular disease population.

The company is hosting a conference call and webcast on September 8, 2025, at 8:00 a.m. Eastern Time to discuss the data. A detailed press release and an investor data presentation have been made available as exhibits and on the company’s website, providing more insight into the trial outcomes.

Positive

• Positive Phase 2 MaGic trial data for DNTH103 in acetylcholine receptor antibody positive generalized myasthenia gravis marks encouraging clinical progress for Dianthus Therapeutics’ lead program.

Negative

• None.

Insights

Biotech and clinical development analyst

Positive Phase 2 gMG data advances DNTH103 in Dianthus’ pipeline.

Dianthus Therapeutics reports positive top-line results from the Phase 2 MaGic trial of claseprubart (DNTH103) in adults with acetylcholine receptor antibody positive generalized myasthenia gravis. Positive Phase 2 data in a defined patient population can be a key value inflection in drug development, as it provides early evidence that the mechanism may work in the target disease.

The focus on both safety and efficacy is important in generalized myasthenia gravis, where long-term treatment tolerability matters alongside symptom control. While the excerpt does not quantify effect size or safety outcomes, the company’s choice to highlight the results and host a same-day webcast suggests the data are directionally favorable for its lead program.

The attached press release and investor presentation, dated September 8, 2025, should contain the detailed endpoints, response rates, and safety profile. Those specifics will shape how the market assesses DNTH103’s competitive positioning and its readiness for potential later-stage trials.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Dianthus Therapeutics (DNTH) announce in this 8-K filing?

Dianthus Therapeutics announced positive top-line data from its Phase 2 MaGic trial evaluating claseprubart (DNTH103) in adults with acetylcholine receptor antibody positive generalized myasthenia gravis.

Which drug and indication are featured in Dianthus Therapeutics Phase 2 MaGic trial?

The trial evaluates claseprubart (DNTH103) in adults with acetylcholine receptor antibody positive generalized myasthenia gravis.

How is Dianthus Therapeutics sharing details of the positive Phase 2 MaGic trial data?

Dianthus is holding a conference call and webcast on September 8, 2025, at 8:00 a.m. Eastern Time and has provided a press release (Exhibit 99.1) and a data presentation (Exhibit 99.2).

Where can investors find Dianthus Therapeutics detailed Phase 2 MaGic trial results?

Detailed information is available in the data press release and data presentation, which are filed as Exhibits 99.1 and 99.2 and posted in the investor relations section of the companys website.

Does this 8-K filing state whether the MaGic trial met specific numerical endpoints?

The excerpt describes the results as positive top-line data on safety and efficacy but does not specify numerical endpoints or effect sizes.

Are the Dianthus Therapeutics Phase 2 MaGic trial materials considered filed or furnished?

The press release is furnished under Item 7.01 and is not deemed filed for Exchange Act Section 18 purposes, while the data presentation is filed as Exhibit 99.2 and incorporated by reference into Item 8.01.

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Accepted by SEC EDGAR 09/08/2025 - 08:01 AM Learn about SEC filing dates

Dianthus Therapeutics, Inc. /DE/ NASDAQ false 0001690585 0001690585 2025-09-08 2025-09-08

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 8, 2025

DIANTHUS THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-38541		81-0724163
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

7 Times Square
43rd Floor
New York, New York		10036
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: 929 999-4055

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 Par Value		DNTH		The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On September 8, 2025, Dianthus Therapeutics, Inc. (the “Company”) issued a press release announcing positive top-line data from the Phase 2 MaGic trial evaluating the safety and efficacy of claseprubart (DNTH103) in adults with acetylcholine receptor antibody positive (AChR+) generalized Myasthenia Gravis (gMG). The Company will host a conference call and webcast today, Monday, September 8, 2025, at 8:00 am, Eastern Time, to discuss the data results.

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.

Item 8.01 Other Events.

On September 8, 2025, the Company made publicly available a data presentation announcing positive top-line data from the Phase 2 MaGic trial evaluating the safety and efficacy of claseprubart (DNTH103) in adults with acetylcholine receptor antibody positive (AChR+) generalized Myasthenia Gravis (gMG) (the “Presentation”) on the investor relations section of its website. The Presentation is filed as Exhibit 99.2 and is incorporated by reference into this Item 8.01.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits. The following exhibit is being furnished herewith:

EXHIBIT INDEX

Exhibit No.		Description
99.1		Data Press Release, dated September 8, 2025
99.2		Data Presentation, dated September 8, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

						DIANTHUS THERAPEUTICS, INC.
Date: September 8, 2025				By:		/s/ Adam M. Veness, Esq.
						Adam M. Veness, Esq.
						SVP, General Counsel and Secretary