Dianthus Therapeutics announces DNTH312, a first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI, for severe autoimmune diseases. August 4, 2026 at 7:00 AM EDT DNTH312 is an internally developed bifunctional fusion protein targeting potent inhibition of active C1s (aC1s) and BAFF/APRIL, two validated pathways with complementary disease modifying mechanisms DNTH312 demonstrated comparable in vitro potency and aC1s inhibition to claseprubart, with a comparable non-human primate (NHP) half-life DNTH312 showed similar depth of Ig reductions vs. povetacicept following a single dose in NHPs By building on claseprubart's best-in-class profile, DNTH312 strengthens Dianthus' leadership in neuromuscular disease, while expanding into additional autoimmune diseases where both B cell modulation and Classical Pathway inhibition could provide additional benefits to more patients DNTH312 aims to be Phase 1 ready by YE'27 NEW YORK and WALTHAM, Mass., Aug. 04, 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 announced DNTH312, an investigational, first-in-class, extended half-life bifunctional fusion protein that combines claseprubart and TACI. DNTH312 is designed to deliver robust Classical Pathway inhibition via aC1s and inhibition of B cell activity via BAFF/APRIL, two validated pathways with complementary disease modifying mechanisms. "We're excited to announce DNTH312 as a new pipeline candidate that originated from our internal research team efforts. DNTH312 combines upstream and downstream inhibition of pathways often responsible for the morbidity seen in autoantibody mediated diseases such as MG, CIDP and MMN, and targets pathways the Dianthus medical team is already expert at evaluating," said Simrat Randhawa, MD, Executive Vice President and Head of Research and Development of Dianthus Therapeutics. DNTH312: Goal to Drive Superior Clinical Efficacy by Targeting Both aC1s and BAFF/APRIL Combining upstream (B-cell) and downstream (classical pathway) inhibition in a single molecule is a very attractive approach in indications where morbidity is largely driven by autoantibodies that can drive inappropriate immune activity including Classical Complement Pathway activation. For example, in MG, targeting B cells via BAFF/APRIL inhibition should reduce autoantibodies that attract local inflammation to the neuromuscular junction, while blocking the Classical Pathway prevents local deposition of pro inflammatory complement components such as C3a and especially the Membrane Attack Complex (MAC). DNTH312 demonstrated comparable in vitro potency and aC1s inhibition to claseprubart across several functional assays of Classical Pathway inhibition. Additionally, DNTH312 is enhanced with YTE half-life extension technology, and has a similar NHP half-life (22 days) to claseprubart, which has an approximately 60-day half-life in humans. DNTH312 also demonstrated a similar depth of IgM, IgA, and IgG reduction following a single dose in NHPs compared to povetacicept, a late-stage, clinically validated BAFF/APRIL inhibitor. This dual mechanism is intended to result in deeper responses, broader symptom control and ability to reach larger target populations of patients with severe autoimmune diseases. Key potential benefits of DNTH312 include: * Comparable NHP half-life to claseprubart: DNTH312 has a similar NHP half-life (22 days) to claseprubart, which has an approximately 60-day half-life in humans * Comparable aC1s inhibition and potency to claseprubart: Demonstrated across multiple complement in vitro pharmacodynamic functional assays * Comparable Ig reductions to povetacicept, with a longer half-life in NHPs: DNTH312 is targeting infrequent, S.C. self-administration * Clinically validated MoAs combined have the potential superior clinical efficacy: Inhibition of the Classical Pathway or aC1s has been clinically validated in generalized Myasthenia Gravis, Chronic Inflammatory Demyelinating Polyneuropathy, Multifocal Motor Neuropathy, and more. BAFF/APRIL has been clinically validated in generalized Myasthenia Gravis, Sjögren's Disease, Systemic Lupus Erythematosus, IgA Nephropathy, Rheumatoid Arthritis, and more * DNTH312 extends its neuromuscular leadership position with new IP protection expected through at least 2047, beyond claseprubart IP protection expected through at least 2043, excluding extensions "With the expertise and knowledge gained from claseprubart, DNTH312 is a natural and highly synergistic fit for Dianthus," said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. "DNTH312 is intended to have wide utility across several therapeutic areas as we continue to expand our leadership in severe autoimmune diseases with our potentially best-in-class, pipeline-in-a-product therapies." DNTH312 aims to be Phase 1 ready by YE'27. About DNTH312 DNTH312 is an internally developed, investigational, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL. DNTH312 is enhanced with YTE half-life extension technology, similar to claseprubart. By targeting two validated pathways with complementary disease modifying mechanisms, DNTH312 is designed to expand Dianthus' leadership position in autoimmune diseases with potential for best-in-disease efficacy by targeting deeper responses and broader symptom control, while also addressing larger patient populations. DNTH312 aims to be Phase 1 ready by YE'27. DNTH312 is an investigational agent that is not approved as a therapy in any indication in any jurisdiction worldwide. About Dianthus Therapeutics Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. Cautionary Statement Regarding Forward-Looking Statements Certain statements in this press release, other than purely historical information, may constitute "forward-looking statements" within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, express or implied statements regarding future plans and prospects, including statements regarding the expectations or plans for discovery, preclinical studies, clinical trials and research and development programs, in particular with respect to claseprubart and DNTH312, and any developments or results in connection therewith, including the target product profile and administration of claseprubart and DNTH312; the anticipated timing of the initiation and results from those studies and trials; expectations regarding the clinical trial designs or indications; expectations regarding the time period over which the Company's capital resources are expected to be sufficient to fund its anticipated operations; and expectations regarding market size, patient population size, and potential market opportunities, in particular with respect to claseprubart and DNTH312. Claseprubart and DNTH312 are investigational agents that are not approved as therapies in any indication in any jurisdiction worldwide. The words "opportunity," "potential," "milestones," "runway," "will," "anticipate," "achieve," "near-term," "catalysts," "pursue," "pipeline," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "possible," "predict," "project," "should," "strive," "would," "aim," "target," "commit," and similar expressions (including the negatives of these terms or variations of them) generally identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Actual results could differ materially from those included in the forward-looking statements due to various factors, risks and uncertainties, including, but not limited to, that preclinical testing of claseprubart and DNTH312 and data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that the development of claseprubart or DNTH312 may take longer and/or cost more than planned, that the Company or its partner may be unable to successfully complete the clinical development of the Company's compounds, that the Company or its partner may be delayed in initiating, enrolling or completing its planned clinical trials, and that the Company's compounds may not receive regulatory approval or become commercially successful products. These and other risks and uncertainties are identified under the heading "Risk Factors" included in the Company's Annual Report on Form 10-K for the period ended December 31, 2025, and other filings that the Company has made and may make with the SEC in the future. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Dianthus undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Dianthus Therapeutics (NASDAQ:DNTH) posts earnings results, misses expectations by $0.05 EPS. August 4, 2026 Key points. * Dianthus Therapeutics reported a quarterly loss of $0.90 per share, missing analyst expectations by $0.05, while revenue of $0.76 million exceeded the $0.30 million consensus estimate. * Shares rose 4.6% to $110.92 after the results, near the stock's 12-month high of $114.55. Analysts maintain a "Moderate Buy" consensus with an average price target of $117.82. * Company insiders sold 87,779 shares worth approximately $8.0 million over the past 90 days, while institutional investors own 47.53% of Dianthus shares. * Five stocks to consider instead of Dianthus Therapeutics. Dianthus Therapeutics (NASDAQ:DNTH - Get Free Report) issued its earnings results on Tuesday. The company reported ($0.90) earnings per share for the quarter, missing analysts' consensus estimates of ($0.85) by ($0.05), FiscalAI reports. The business had revenue of $0.76 million for the quarter, compared to the consensus estimate of $0.30 million. Dianthus Therapeutics had a negative return on equity of 27.30% and a negative net margin of 12,998.50%. Dianthus Therapeutics stock up 4.6%. Shares of DNTH traded up $4.89 during mid-day trading on Tuesday, hitting $110.92. 636,619 shares of the company's stock were exchanged, compared to its average volume of 978,479. The stock has a market cap of $6.06 billion, a price-to-earnings ratio of -26.86 and a beta of 1.22. The firm has a fifty day moving average of $93.02 and a two-hundred day moving average of $79.05. Dianthus Therapeutics has a twelve month low of $18.08 and a twelve month high of $114.55. Analysts set new price targets. A number of equities research analysts have recently issued reports on the company. TD Cowen reaffirmed a "buy" rating on shares of Dianthus Therapeutics in a research report on Wednesday, June 10th. Wall Street Zen upgraded Dianthus Therapeutics from a "sell" rating to a "hold" rating in a research report on Saturday, May 9th. Wedbush upped their price objective on shares of Dianthus Therapeutics from $103.00 to $105.00 and gave the company an "outperform" rating in a research note on Wednesday, May 6th. Raymond James Financial reiterated a "strong-buy" rating on shares of Dianthus Therapeutics in a research report on Wednesday, June 10th. Finally, Wolfe Research reissued an "outperform" rating on shares of Dianthus Therapeutics in a research note on Wednesday, June 10th. One research analyst has rated the stock with a Strong Buy rating, twelve have given a Buy rating and one has assigned a Sell rating to the stock. Based on data from MarketBeat.com, Dianthus Therapeutics has an average rating of "Moderate Buy" and an average target price of $117.82. Insider activity at Dianthus Therapeutics. In related news, SVP Adam M. Veness sold 30,000 shares of the company's stock in a transaction on Wednesday, June 17th. The shares were sold at an average price of $80.80, for a total value of $2,424,000.00. Following the completion of the sale, the senior vice president directly owned 30,000 shares in the company, valued at approximately $2,424,000. This represents a 50.00% decrease in their ownership of the stock. The sale was disclosed in a document filed with the SEC, which is accessible through this link. Also, EVP Ryan Savitz sold 31,249 shares of the company's stock in a transaction dated Thursday, July 9th. The stock was sold at an average price of $101.03, for a total value of $3,157,086.47. Following the sale, the executive vice president owned 31,249 shares of the company's stock, valued at approximately $3,157,086.47. This trade represents a 50.00% decrease in their position. The SEC filing for this sale provides additional information. In the last 90 days, insiders sold 87,779 shares of company stock valued at $7,985,235. Insiders own 3.02% of the company's stock. Hedge funds weigh in on Dianthus Therapeutics. Several large investors have recently added to or reduced their stakes in DNTH. Wellington Management Group LLP increased its holdings in Dianthus Therapeutics by 3,366.9% in the 3rd quarter. Wellington Management Group LLP now owns 2,577,662 shares of the company's stock valued at $101,431,000 after buying an additional 2,503,311 shares during the period. Vestal Point Capital LP lifted its holdings in shares of Dianthus Therapeutics by 88.2% during the 2nd quarter. Vestal Point Capital LP now owns 3,200,000 shares of the company's stock worth $59,616,000 after acquiring an additional 1,499,931 shares during the period. State Street Corp lifted its holdings in shares of Dianthus Therapeutics by 124.7% during the 4th quarter. State Street Corp now owns 1,507,619 shares of the company's stock worth $62,129,000 after acquiring an additional 836,571 shares during the period. Polar Capital Holdings Plc acquired a new stake in shares of Dianthus Therapeutics during the 3rd quarter valued at about $29,434,000. Finally, Marshall Wace LLP acquired a new stake in shares of Dianthus Therapeutics during the 3rd quarter valued at about $22,545,000. Institutional investors and hedge funds own 47.53% of the company's stock. Dianthus Therapeutics company profile. Dianthus Therapeutics, Inc, a clinical-stage biotechnology company, develops complement therapeutics for patients with severe autoimmune and inflammatory diseases. It is developing DNTH103, a monoclonal antibody, which is in Phase 2 clinical trial, for the treatment of generalized myasthenia gravis, multifocal motor neuropathy, and chronic inflammatory demyelinating polyneuropathy. Dianthus Therapeutics, Inc was founded in 2019 and is headquartered in New York, New York. Further reading. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Continue following MarketBeat Before you consider Dianthus Therapeutics, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Dianthus Therapeutics wasn't on the list. While Dianthus Therapeutics currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. 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Cormorant Asset Management acquired 950,000 shares of Dianthus Therapeutics in a $55.01 million transaction disclosed on 15 May 2026, establishing a new position representing 4% of the fund's reported assets under management. The investment comes as Dianthus shares have surged 350% over the past year to $85.34, giving the clinical-stage biotechnology company a $4 billion market capitalisation. The company develops monoclonal antibody therapies for severe autoimmune diseases, with lead candidate DNTH103 targeting conditions including generalised myasthenia gravis. Dianthus recently announced accelerated progress in its Phase 3 CAPTIVATE trial and ended the quarter with approximately $1.2 billion in cash following a $719 million capital raise, providing a projected runway into 2030. The position now ranks sixth among Cormorant's holdings.