Every 8-K that Dianthus Therapeutics, Inc. (DNTH) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow DNTH and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full DNTH filings page.
Dianthus Therapeutics, Inc. reported second-quarter 2026 results and highlighted progress across its autoimmune pipeline. Lead asset claseprubart, a subcutaneous aC1s inhibitor, advanced with initiation of the Phase 3 EMERGE registrational trial in generalized myasthenia gravis, with top-line results anticipated in 2H 2028. In chronic inflammatory demyelinating polyneuropathy, the Phase 3 CAPTIVATE trial showed a 75% response rate in an interim analysis of the first 40 Part A participants, exceeding the 50% target, and the Phase 2 MoMeNtum trial in multifocal motor neuropathy completed enrollment above its 36-patient target, with 46 patients and top-line data expected in December 2026.
The company is building a rheumatology franchise with DNTH212, with Phase 1 healthy volunteer data anticipated by year-end 2026, and advancing DNTH312, a next-generation bifunctional fusion protein aiming to be Phase 1 ready by year-end 2027. Cash, cash equivalents and investments totaled approximately $1.2 billion as of June 30, 2026, providing expected runway into 2030. For the quarter, research and development expenses were $48.7 million and general and administrative expenses were $13.6 million. Net loss was $50.2 million, or $0.90 per share, compared with $31.6 million, or $0.88 per share, in the prior-year quarter.
Dianthus Therapeutics posted an updated corporate presentation highlighting new clinical and strategic data for its autoimmune pipeline. The company reported an interim responder analysis from Part A of the Phase 3 CAPTIVATE trial of claseprubart in chronic inflammatory demyelinating polyneuropathy, where 75% of the first 40 participants who completed Part A were confirmed responders based on adjusted INCAT improvement. The presentation also detailed Phase 2 MaGic trial results in generalized myasthenia gravis, showing statistically significant and clinically meaningful improvements versus placebo across multiple endpoints, including MG-ADL, QMG, MGC, MG-QoL-15r and Minimal Symptom Expression at Week 13 for the 300mg/2mL dose. Claseprubart was generally well tolerated in Phase 1 and 2 with no signal of encapsulated bacterial infections or clinical symptoms of drug-induced lupus, supporting a target profile without a boxed warning or REMS. Dianthus additionally highlighted DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor in Phase 1, and reported cash, cash equivalents and investments of about $1.2B as of March 31, 2026 with runway expected into 2030.
Dianthus Therapeutics reported results from its annual stockholder meeting held on May 21, 2026. Stockholders elected Sujay Kango, Anne McGeorge and Jonathan Violin, Ph.D. as Class II directors to serve until the 2029 annual meeting. An advisory vote approved executive compensation, with 41,004,507 votes for and 1,713,043 against. Stockholders also ratified Deloitte & Touche LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 46,298,319 votes for and minimal opposition.
Dianthus Therapeutics reported a Q1 2026 net loss of $40.8 million, or $0.85 per share, as it increased investment in its autoimmune disease pipeline. License revenue was $0.5 million, while higher research and administrative costs continued to drive operating losses.
The company ended the quarter with approximately $1.2 billion in cash, cash equivalents and investments, supported by an upsized underwritten offering that generated about $719 million in gross proceeds, which it expects to fund operations into 2030. Management highlighted an early GO decision in the CAPTIVATE CIDP trial, Orphan Drug Designation for claseprubart in Myasthenia Gravis, and progress on the gMG Phase 3 program, the MMN Phase 2 trial, and the DNTH212 Phase 1 study and planned rheumatology indications.
Dianthus Therapeutics reports that in the first quarter of 2026 it proposed, and in March 2026 received, written FDA agreement to three changes across all ongoing and planned claseprubart trials. Anti-nuclear antibodies will no longer be used as a screening criterion or routinely tested, and the hypothetical safety risk is reclassified from systemic lupus erythematosus to drug-induced lupus. The company notes there have been no cases of SLE or DIL in any claseprubart program to date.
Dianthus’ investor presentation highlights claseprubart and DNTH212 as pipeline-in-a-product autoimmune therapies, with strong Phase 2 gMG data, an early Phase 3 CIDP “GO” decision, and broad neuromuscular and autoimmune indications under study. The company cites a strong financial position with approximately $1.2 billion of pro forma cash and runway expected into 2030, supporting multiple planned milestones, including a Phase 3 gMG trial initiation, Phase 2 MMN data, CAPTIVATE Part B readout guidance in CIDP, and Phase 1 top-line results for DNTH212.
Dianthus Therapeutics, Inc. entered an underwriting agreement to conduct a public offering of its common stock and pre-funded warrants. The company is issuing 7,313,582 shares of common stock at $81.00 per share and pre-funded warrants for 402,468 shares at $80.999 per warrant.
The underwriters received a 30-day option to buy up to 1,157,407 additional shares at the public offering price, less discounts, and exercised this option in full on March 11, 2026. Including this option exercise, Dianthus expects net proceeds of approximately $673.5 million after underwriting discounts, commissions and estimated expenses.
The pre-funded warrants are exercisable at any time after issuance with a $0.001 per share exercise price, subject to beneficial ownership limits of 4.99%, 9.99% or 19.99%, adjustable up to 19.99% with at least 61 days’ prior notice.
Dianthus Therapeutics reported a larger 2025 net loss while advancing its autoimmune pipeline and securing an early positive signal in its key CIDP program.
For the year ended December 31, 2025, the company posted a net loss of $162.3 million, or $4.20 per share, driven mainly by higher research and development spending of $145.6 million and general and administrative expenses of $34.3 million. Cash, cash equivalents and investments totaled $514.4 million, which the company expects to fund operations into 2028.
Dianthus announced an early GO decision in its Phase 3 CAPTIVATE trial of claseprubart in CIDP after achieving 20 confirmed responders with fewer than 40 participants completing Part A, with no related serious infections or serious adverse events reported. The company plans to streamline Part B to 128 randomized patients and expects Part B top-line guidance by year-end 2026. It also plans a Phase 3 trial in generalized myasthenia gravis starting mid-2026, a Phase 2 readout in multifocal motor neuropathy in the second half of 2026, and Phase 1 healthy volunteer data for DNTH212 in the second half of 2026.
Dianthus Therapeutics, Inc. filed a current report describing preliminary year-end liquidity. The company’s audited financial statements for the year ended December 31, 2025 are not yet available, but it expects to report approximately $514 million in cash, cash equivalents, and short-term investments as of December 31, 2025. This estimate is preliminary, unaudited, and subject to completion of year-end closing procedures, so actual results may differ materially.
The cash information is being shared in an investor presentation furnished as an exhibit, which will be used in meetings beginning January 12, 2026. The same presentation will also be used when President and CEO Marino Garcia speaks at the 44th Annual J.P. Morgan Healthcare Conference. The company notes that the presentation includes forward-looking statements and provides related cautionary language.
Dianthus Therapeutics filed an 8-K stating it furnished a press release with financial results for the quarter ended September 30, 2025. The release is attached as Exhibit 99.1. The information is furnished under Item 2.02 and is not deemed filed under Section 18, nor incorporated by reference except if specifically referenced.
Dianthus Therapeutics (DNTH) filed an 8-K to announce it has posted an updated corporate presentation on its investor relations website. The presentation is furnished as Exhibit 99.1 and is incorporated by reference.
The company notes the presentation contains forward-looking statements and includes cautionary language directing readers to related risk considerations. This is an informational update and does not disclose transaction terms or financial results.
Dianthus Therapeutics entered a License and Collaboration Agreement with Nanjing Leads Biolabs, securing exclusive rights outside Greater China to develop and commercialize DNTH212 (LBL-047), an investigational bifunctional fusion protein that targets pDC BDCA2 to reduce Type 1 interferon while inhibiting BAFF/APRIL to suppress B-cell function.
Consideration includes up to $38 million, comprised of $30 million in upfront and near‑term milestone payments and an additional $8 million milestone payable at the initiation of a Dianthus‑led Phase 1 study, at the company’s election in cash or stock. Leads may earn up to $962 million in development, regulatory, and sales milestones across five indications, plus tiered royalties from mid‑single digits up to low double‑digit on ex‑Greater China net sales.
A joint steering committee will oversee DNTH212; Leads can participate in global studies and enroll patients in Greater China and will cover certain related costs. The parties agreed to non‑competition outside Greater China. Dianthus reported approximately $555 million in cash, cash equivalents, and investments as of September 30, 2025, and $525 million pro forma after deducting near‑term and upfront payments.
Dianthus Therapeutics entered into an underwriting agreement to sell 6,487,879 shares of common stock at $33.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,112,121 shares at $32.999 per pre-funded warrant. The company also granted the underwriters an option to buy up to an additional 1,140,000 shares of common stock at the public offering price, less underwriting discounts and commissions, and this option has been exercised in full. Net proceeds from this equity and pre-funded warrant offering, including the exercised option, are expected to be approximately $270.0 million after underwriting discounts, commissions, and estimated expenses. The securities are being issued off an effective shelf registration statement, with the offering expected to close on September 11, 2025.
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.