NEW YORK and WALTHAM, Mass., Feb. 24, 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 the Company’s participation in the TD Cowen 46th Annual Health Care Conference in Boston. Marino Garcia, CEO of Dianthus Therapeutics, will participate in an analyst-led fireside chat on Tuesday, March 3, 2026 at 1:50 pm EST and will host one ...

Company Overview - Dianthus Therapeutics is currently experiencing a transformative period, highlighted by significant advancements in their clinical data for myasthenia gravis, a neuromuscular condition, which has been positively received by investors [4]. Product Development - The company has in-licensed a promising product, referred to as 212, from Leads Bio in China. This product is characterized as a potential best-in-class bifunctional fusion protein that targets BDCA2 to reduce Type 1 interferon and BAFF/APRIL [4]. - Preliminary results indicate that this product may demonstrate greater potency than Litifilimab, which is part of Biogen's portfolio and is currently being studied for systemic lupus erythematosus (SLE) [4].

Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Date**: February 12, 2026 - **Key Executives**: Marino Garcia (CEO), Ryan Savitz (CFO) Key Industry and Company Insights 1. Transformational Year - 2025 was a pivotal year for Dianthus, marked by the first patient data in myasthenia gravis (MG), which exceeded expectations [2][60] 2. Product Pipeline - **DNTH212**: In-licensed from Leads Biolabs, a bifunctional fusion protein targeting BDCA2 to reduce type I interferon and BAFF/APRIL, showing potential as a best-in-class product [2][3] - **Clasiprubart**: An active C1s inhibitor with promising phase 2 data for MG, with two major catalysts expected in 2026 [3][4] 3. Upcoming Catalysts - **CIDP Phase 3 Study**: Interim responder analysis for the first 40 patients is anticipated in Q2 2026, accelerated from H2 2026 due to strong recruitment [4][16] - **MMN Phase 2 Results**: Expected in the second half of 2026 [4] 4. Competitive Landscape - **Riliprubart**: A competitor from Sanofi, currently in phase 3 studies for CIDP. Dianthus aims to demonstrate at least equal efficacy with a more convenient dosing regimen [10][12] - **Empaciperbart**: Another competitor in MMN, with Dianthus expecting similar efficacy but with advantages in administration and safety [31][39] 5. Efficacy Expectations - For CIDP, Dianthus aims for a responder rate of 40%-50% in the interim analysis, comparable to riliprubart's phase 2 data [12][17] - The company is focusing on a dosing regimen that is more efficient, potentially reducing the number of injections required [12][15] 6. Market Potential - The U.S. market for MG is estimated at $5 billion, with potential growth to $20-$25 billion as biologics penetrate further [60] - Dianthus anticipates capturing 5%-10% of the MG market, translating to $2-$4 billion in sales [60][62] 7. Financial Health - Dianthus ended the year with $514 million in cash, sufficient to fund operations through 2028 and support upcoming milestones [64] 8. Safety and Regulatory Considerations - Concerns about drug-induced lupus (DIL) were addressed, emphasizing the reliability of data from clinical trials versus anecdotal reports [54][56] - The company is confident in the safety profile of its products, with no reported cases of DIL in clinical programs [56] 9. Commercial Strategy - Dianthus plans to leverage the convenience of its auto-injector and the absence of a box warning to differentiate its products in the market [41][44] 10. Recruitment and Trial Design - The company is focusing on efficient recruitment strategies and trial designs that allow for quicker results and better patient outcomes [16][20] Conclusion Dianthus Therapeutics is positioned for significant growth with a strong pipeline and strategic focus on efficacy, safety, and market penetration. The upcoming data releases and competitive advantages in product administration are critical to its success in the evolving biotech landscape.

Core Insights - Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation therapies for severe autoimmune diseases [3] Group 1: Company Participation - Dianthus Therapeutics will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York City [1] - CEO Marino Garcia will engage in an analyst-led fireside chat on February 12, 2026, at 10:00 am EST and will conduct one-on-one meetings with investors [1] Group 2: Company Overview - The company is based in New York City and Waltham, Massachusetts, and is led by an experienced team of biotech and pharmaceutical executives [3] - Dianthus aims to deliver transformative medicines for individuals suffering from severe autoimmune and inflammatory diseases [3]

Core Insights - Dianthus Therapeutics, Inc. (DNTH) shares experienced a significant increase of 9.9% to $52.76, with trading volume surpassing the average [1] - The rise in stock price is linked to positive investor sentiment regarding the company's clinical-stage pipeline candidates, claseprubart and DNTH212, aimed at treating various autoimmune conditions [2] Financial Performance - The company is projected to report a quarterly loss of $0.97 per share, reflecting a year-over-year decline of 19.8%, with expected revenues of $0.52 million, down 61% from the previous year [3] - The consensus EPS estimate for the upcoming quarter has remained unchanged over the last 30 days, indicating a lack of upward revisions in earnings estimates [4] Industry Context - Dianthus Therapeutics is part of the Zacks Medical - Biomedical and Genetics industry, where Royalty Pharma (RPRX) also operates, finishing the last trading session 1% higher at $40.11 [4] - Royalty Pharma's consensus EPS estimate for its upcoming report is $1.33, representing a year-over-year increase of 15.7%, with a Zacks Rank of 3 (Hold) [5]

Core Viewpoint - Dianthus Therapeutics is focused on developing innovative autoimmune therapeutics with a strong pipeline aimed at patient-friendly self-administration methods [3]. Group 1: Product Development - The company is advancing two clinical-stage autoimmune therapeutics, emphasizing their best-in-class potential and infrequent subcutaneous self-administration [3]. - The first program, claseprubart, is a potent classical pathway inhibitor with an 8-week half-life, targeting activated C1s, and has shown positive Phase II results in Myasthenia Gravis (MG) [4]. - Clinical proof of concept has been established for classical pathway inhibition in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN) [4]. - The product is designed for convenience, utilizing a single self-administered 300-milligram 2-milliliter auto-injector, with dosing every two or four weeks [4]. Group 2: Clinical Trials - The second program, DNTH212, has recently commenced its Phase I clinical trials [5].

Dianthus Therapeutics FY Conference Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Focus**: Development of clinical-stage autoimmune therapeutics with a best-in-class pipeline targeting patient-friendly, infrequent subcutaneous self-administration [2][3] Key Products and Pipeline Clasibobart - **Description**: A potent classical pathway inhibitor with an eight-week half-life, targeting activated C1s - **Clinical Status**: Positive phase two results disclosed in September, with clinical proof of concept for classical pathway inhibition in Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [2][4] - **Administration**: 300 mg, 2 ml autoinjector dosed every two or four weeks [3][5] - **Market Potential**: Targeting over 150,000 patients in the U.S. for MG, CIDP, and Multifocal Motor Neuropathy (MMN) [5][6] - **Efficacy Data**: Impressive results with 300 mg every two weeks showing robust, statistically significant efficacy across five measures in MG [6][9] - **Phase 3 Trial**: Discussions with the FDA ongoing, aiming for a trial comparing placebo, Clasibobart every two weeks, and every four weeks [11][12] DNTH212 - **Description**: A bispecific fusion protein targeting BDCA2 and BAFF/APRIL pathways - **Clinical Status**: Currently in phase 1 trials, with plans to prioritize indications such as Systemic Lupus Erythematosus (SLE) and dermatomyositis [25][26] Market Opportunities Myasthenia Gravis (MG) - **Market Size**: Approximately 100,000 patients in the U.S. with ACHR positive MG [5] - **Competitive Advantage**: Clasibobart's mechanism may provide superior efficacy compared to existing C5 inhibitors by preventing pro-inflammatory toxins [10][11] Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - **Market Need**: High unmet need due to limitations of current treatments like IVIG and FcRns [13][14] - **Efficacy Signals**: Clasibobart showed better efficacy than IVIG in patients refractory to standard treatments [14][15] Multifocal Motor Neuropathy (MMN) - **Market Size**: Estimated 10,000-15,000 patients in the U.S. with a high potential for a blockbuster product due to lack of competition [21][33] - **Competitive Landscape**: Clasibobart is positioned against Empasibobart, with superior potency and a more convenient administration route [22][24] Financial Position - **Cash Reserves**: Approximately $514 million, providing a runway into 2028 [27] Additional Insights - **Trial Design**: Clasibobart's trial design allows for immediate switching from IVIG to Clasibobart, which may yield higher responder rates compared to traditional methods [19][20] - **Market Strategy**: Emphasis on the potential for Clasibobart to be the most convenient and patient-friendly biologic in MG and CIDP [12][13] - **Investor Considerations**: The company highlights the importance of looking at actions and trial designs rather than just statements when evaluating potential success [31][32] Conclusion Dianthus Therapeutics is positioned to make significant advancements in the treatment of autoimmune diseases with its innovative therapies, particularly Clasibobart, which shows promise in multiple indications and has a strong clinical and market strategy. The upcoming phase 3 trial and interim analyses are critical milestones to watch for potential investment opportunities.

Core Insights - The transaction indicates a complete disposition of direct equity holdings by Savitz Ryan, resulting in zero remaining directly held shares for future sales unless additional equity is acquired or more options are exercised [1][4]. Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing monoclonal antibody therapies for severe autoimmune and inflammatory conditions, including diseases like generalized myasthenia gravis and multifocal motor neuropathy [6]. Transaction Details - On December 4, 2025, Savitz Ryan, CFO & CBO of Dianthus Therapeutics, exercised 20,000 stock options and sold the shares for a total of $903,600, at a weighted average price of $45.18 per share [4][5]. - The transaction was executed entirely through direct holdings, with no participation from indirect entities such as trusts or LLCs [2][5]. Market Context - Dianthus Therapeutics experienced significant gains after issuing 7.6 million shares at $33 per share, raising $288 million for development activities, and reported promising clinical trial results in its third-quarter earnings [9]. - The stock price has retreated from its high but remains around $38, with analysts estimating a one-year target of $63 [9].

Core Viewpoint - Dianthus Therapeutics, Inc. is actively participating in the 44th Annual J.P. Morgan Healthcare conference, highlighting its commitment to developing next-generation therapies for severe autoimmune diseases [1]. Group 1: Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on transforming the treatment of severe autoimmune diseases [3]. - The company is based in New York City and Waltham, Massachusetts, and is led by an experienced team of biotech and pharmaceutical executives [3]. - Dianthus aims to deliver transformative medicines for individuals suffering from severe autoimmune and inflammatory diseases [3]. Group 2: Event Participation - CEO Marino Garcia will present a corporate overview at the J.P. Morgan Healthcare conference on January 12, 2026, at 3:00 pm PST / 6:00 pm EST [1]. - The company will also host one-on-one meetings with investors during the conference [1]. - A webcast of the presentation will be available in the "News and Events" section of the Dianthus Therapeutics website [2].

Summary of Key Points from Biotechnology Equity Research Conference Call Industry Overview - The report focuses on the biotechnology sector, specifically highlighting companies with significant potential for growth and upcoming catalysts in 2026. Key Companies and Their Outlook 1. **Dianthus Therapeutics, Inc. (DNTH)** - Market Cap: $1.82 billion - Price Target: $66 - Key catalysts include: - CIDP Phase III interim analysis in Q2 2026 - Initiation of gMG Phase III study in mid-2026 - Phase II MMN topline data in 2H26 - Potential for significant upside based on peak revenue estimates of ~$2 billion across neuromuscular diseases [19][20][24] 2. **Taysha Gene Therapies, Inc. (TSHA)** - Market Cap: $1.50 billion - Price Target: $11 - Focus on pivotal study for TSHA-102 in Rett syndrome with potential for a 6-month interim readout by YE26/1Q27 [26][27] 3. **Tyra Biosciences (TYRA)** - Market Cap: $1.36 billion - Price Target: $32 - Major catalysts include: - Phase III data for achondroplasia in early 2026 - Initial data for IR-NMIBC in 1H26 - Potential to disrupt the market with oral FGFR3 inhibitors [31][35] 4. **Tango Therapeutics, Inc. (TNGX)** - Market Cap: $1.15 billion - Price Target: $14 - Expected to show de-risking data for vopimetostat in combination with RVMD's RAS inhibitors in 2026 [37][40] 5. **ORIC Pharmaceuticals (ORIC)** - Market Cap: $783 million - Price Target: $23 - Key catalysts include dose-optimization data for prostate cancer and validating data from PFE's MEVPRO-1 trial [42][48] 6. **Solid Biosciences (SLDB)** - Market Cap: $463 million - Price Target: $15 - Focus on DMD program with key regulatory feedback expected in 1H26 [49][53] Major Catalysts and Events - **Upcoming Catalysts:** - RARE and MREO Phase III ORBIT final analysis expected in Dec'25/Jan'26 with potential stock movements of +100%/-30% [2] - ALNY, CRSP, and others expected to provide revenue guidance and business plans early in 2026 [1] - Regulatory events including FDA's Rare Disease Day on 2/23/26 [12] - **Drug Launches:** - Expected launches in 2026 include drugs from ALNY, ARWR, KALV, and others targeting various conditions [3] Financial Updates - **Price Target Changes:** - ARWR raised from $67 to $90 - KOD raised from $24 to $39 [6][10] Market Dynamics - **Pricing Stability:** - 2026 net pricing expected to remain stable with current Medicare contracts influencing high gross-to-net (GTN) guidance [12] - **Strategic Interest:** - Potential for M&A activity as companies like ORIC attract interest due to their prostate cancer programs [43] Conclusion - The biotechnology sector is poised for significant developments in 2026, with multiple companies presenting strong investment opportunities based on upcoming catalysts, drug launches, and strategic positioning in the market.