NEW YORK and WALTHAM, Mass., Nov. 24, 2025 (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 8th Annual Evercore Healthcare Conference in Coral Gables, Florida. Marino Garcia, CEO of Dianthus Therapeutics, will participate in a fireside chat on Tuesday, December 2, 2025 at 2:35 p.m. ET and will host ...

Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Focus**: Development of therapies for autoimmune diseases, specifically targeting myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) Key Developments Claseprubart (C1s Inhibitor) - **Phase 2 Data**: Positive results for myasthenia gravis with a 300 mg dose every two weeks showing rapid efficacy across five measures [2][3] - **Phase 3 Plans**: Transitioning to phase 3 with both every two-week and every four-week dosing paradigms [3][10] - **Efficacy Comparison**: Anticipated better efficacy than traditional complement inhibitors (C5s) due to its upstream inhibition mechanism [5][6] - **Placebo Response**: Noted a high placebo response in phase 2, which may be mitigated by adjusting screening criteria for future studies [16][17] Financial Position - **Funding**: Recently raised $288 million, resulting in a cash balance of approximately $525 million, providing a runway into 2028 [8] DNTH212 (Bifunctional Fusion Protein) - **Mechanism**: Targets both innate and adaptive immune systems, aiming for infrequent subcutaneous self-administration [9] - **Phase 1 Study**: IND cleared in the U.S. and soon in China, with a single-dose study in healthy volunteers starting imminently [10] Upcoming Catalysts - **Phase 3 for Claseprubart**: Expected to start in 2026, with details to be announced post-FDA alignment [10][40] - **CIDP Interim Analysis**: Results anticipated in the second quarter of 2026, moved up from the second half of the year [10][40] - **MMN Phase 2 Results**: Expected in the second half of 2026 [10][40] Market Positioning and Pricing Strategy - **Pricing Considerations**: Pricing for MG will inform CIDP and MMN pricing strategies, with potential flexibility based on market dynamics [31][32] Competitive Landscape - **Comparison with Competitors**: Dianthus aims to differentiate itself from competitors like Sanofi and Argenx by offering improved dosing and administration [22][30][34] Conclusion - **Strategic Focus**: Dianthus is positioned to leverage its innovative therapies in the autoimmune space, with a strong financial foundation and a clear roadmap for upcoming clinical trials and market entry strategies [40]

Group 1 - The core viewpoint of the articles highlights the strong performance of innovative drug stocks in the market, with notable increases in share prices for companies such as Gilead Sciences-B (up 8.82%) and Kintor Pharmaceutical (up 4.60%) [1] - The report from CICC emphasizes the importance of innovative drugs and medical devices in China's "14th Five-Year Plan," indicating a shift from "follow-up innovation" to "quality transformation" in domestic innovative drugs [1] - The collaboration between Hansoh Pharmaceutical and Roche for the global exclusive license of the antibody-drug conjugate HS-20110 is seen as a significant advancement, with expectations for smooth development due to Roche's expertise [2] Group 2 - The partnership between Innovent Biologics and Takeda Pharmaceutical aims to advance the development of next-generation tumor immunotherapy and antibody-drug conjugates, leveraging Takeda's strong sales network in Japan and the West [2] - Valiant Pharmaceuticals' agreement with the U.S. company Dianthus for the development and commercialization of its autoimmune drug LBL-047 outside Greater China is viewed as beneficial for product development [2] - The overall sentiment in the pharmaceutical industry is optimistic regarding the international expansion of innovative drugs, with multiple companies securing significant partnerships to enhance their research and commercialization efforts [2]

Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Focus**: Biotech company specializing in autoimmune diseases with two main programs, including Claseprubart, a potent active C1s inhibitor [2][3] Key Points and Arguments Lead Program: Claseprubart - **Mechanism**: Claseprubart is an active C1s inhibitor with a half-life of 60 days, aimed at delivering best-in-class efficacy for conditions like Myasthenia Gravis (MG) [3][4] - **Efficacy**: Phase two data for MG showed a significant 3-point difference on the MG-ADL scale compared to placebo, indicating superior efficacy over existing therapies [12] - **Safety Profile**: Improved safety profile compared to current complement therapies, with no box warning or REMS program required [3][4][20] - **Dosing Strategy**: Plans to test both bi-weekly and monthly dosing in phase three trials, with expectations of maintaining efficacy at lower dosing frequencies [4][17] Upcoming Trials and Data - **CIDP and MMN**: Ongoing development in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN), with interim analysis for CIDP expected in Q2 2026 [5][29] - **Funding**: Company has raised approximately $525 million, providing a runway into 2028 [5] Competitive Landscape - **Market Position**: Currently, only C5 inhibitors are approved for MG, with Claseprubart positioned to offer a safer and potentially more effective alternative [9][10] - **Comparison with Competitors**: Other therapies like Enjaymo (C1s inhibitor) and Regeneron's simdisiran (C5 inhibitor) are mentioned, highlighting the unique advantages of Claseprubart [10][16] New Pipeline Addition - **Bifunctional Fusion Protein**: Recently in-licensed a bifunctional fusion protein targeting both innate and adaptive immune systems, expected to enter clinical trials soon [5][41] - **Indications**: Targeting diseases where both immune systems are involved, with potential for superior efficacy [6][45] Safety and Regulatory Considerations - **Safety Monitoring**: No significant safety concerns reported in phase two trials, with no cases of autoimmune activation or serious infections [20][21] - **Regulatory Strategy**: Plans to align with FDA guidelines to streamline safety monitoring processes in future trials [20] Market Potential - **MMN Market**: Although smaller, MMN presents an opportunity for Dianthus to leverage existing infrastructure and expertise from MG and CIDP programs [39] - **Future Growth**: Anticipation of increased diagnosis and treatment options in MMN, similar to trends observed in MG and CIDP [39] Additional Important Insights - **Investor Sentiment**: Positive reception from physicians regarding MG data has accelerated recruitment for CIDP trials [34][36] - **Trial Design**: Emphasis on open-label responder portions in trials to enhance patient experience and recruitment [28][29] This summary encapsulates the key points discussed during the conference call, highlighting Dianthus Therapeutics' strategic direction, competitive advantages, and future growth potential in the biotech sector focused on autoimmune diseases.

Dianthus Therapeutics Conference Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Event**: First annual I&I Summit - **Date**: November 12, 2025 Key Points Product Development and Trials - **Claseprubart**: The company is preparing for the Phase 3 trial design for claseprubart, following positive results from the Phase 2 MAGIC study [5][6] - **FDA Interaction**: Dianthus has not yet discussed the Phase 3 trial changes with the FDA but plans to meet to discuss the addition of a Q4 week dosing arm alongside the Q2 week arm [6][8] - **Dosing Strategy**: The company is focusing on a dosing strategy of 300 mg every two weeks and is considering once-a-month dosing based on data consistency from various studies [9][39] Screening Criteria - **QMG Score**: The company is debating the inclusion of a QMG score screening criterion for the Phase 3 trial, noting that previous trials did not use such criteria and that it could complicate patient recruitment [10][11] - **Baseline Characteristics**: The baseline QMG scores in their trial were lower than historical data, which may indicate that the efficacy results are even more impressive given the milder patient population [12][15] Autoantibody Positivity and Safety - **ANA Signal**: The company reported that the ANA signal observed in the MAGIC study does not correlate with clinical symptoms, and they plan to limit ANA testing in future trials to only symptomatic patients [16][19] - **Drug-Induced Lupus**: There is no evidence that the drug causes drug-induced lupus, and the company plans to follow a similar approach to other successful trials by limiting unnecessary testing [17][20] Recruitment and Trial Design - **Captivate Trial**: The Captivate trial is enrolling faster than expected, with interim data anticipated in Q2. The design allows for a more attractive patient experience compared to competitors [22][26] - **Patient Recruitment**: The company believes that the design of their trials, which allows for immediate drug administration and less frequent visits, makes it more appealing for patients and investigators [23][25] Future Plans - **Momentum MMN Study**: The Phase 2 study is expected to report top-line results in the second half of the year, with a focus on safety and efficacy compared to existing treatments [40][41] - **Auto Injector Development**: Dianthus is working on a subcutaneous auto-injector strategy, aiming for a label similar to Dupixent, which would allow for easier patient administration [42][44] Competitive Landscape - **Differentiation**: The company aims to differentiate itself from competitors by offering a more potent classical pathway inhibitor and a more patient-friendly trial design [41][39] Additional Insights - **Market Positioning**: The company is positioning itself strongly in the market by focusing on patient-centric trial designs and effective dosing strategies, which could enhance its competitive edge in the therapeutic landscape [39][26] - **Regulatory Strategy**: The company is confident in its regulatory strategy, leveraging existing successful auto-injector designs to streamline the approval process [44][45]

Dianthus Therapeutics FY Conference Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Focus**: Development of autoimmune therapeutics with best-in-class potential, specifically targeting myasthenia gravis and other neuromuscular indications [6][16] Key Products and Pipeline 1. **Clecipabar** - A potent active C1s inhibitor aimed at treating myasthenia gravis - Recent phase two data showed statistically significant efficacy across five measures, including MGADL and QMG [8][14] - Moving forward with a phase three trial using a 300 mg dose every two weeks, with potential for a once-a-month dosing strategy [14][16] 2. **DNTH212** - A bifunctional fusion protein licensed from Leed BioLabs, targeting two mechanisms of action for improved efficacy in autoimmune diseases [7][15] - Expected to allow for dosing every four to eight weeks, enhancing patient convenience [15][17] Clinical Data Highlights - **Phase Two Data for Clecipabar**: - 300 mg dose showed robust efficacy with a 2.8 response on MGADL in placebo patients transitioning to treatment [12][14] - Additional data suggested that dosing every four weeks could be as effective as every two weeks [13][14] - Historical comparisons indicate potential for superior efficacy over existing treatments [14][38] - **CIDP Program**: - Accelerated interim responder analysis expected in Q2 2026, showcasing operational efficiency in patient recruitment [16][18] - Unique trial design allows for immediate switch from IVIG to clecipabar without requiring patient relapse [20][21] Market Positioning and Strategy - **CIDP Treatment Paradigm**: - Potential to shift treatment standards if clecipabar demonstrates superior efficacy compared to IVIG and FcRNs [37][38] - Emphasis on patient-friendly administration and reduced side effects compared to current therapies [38] - **MMN Program**: - Smaller but untapped market with potential for significant revenue, aiming for a self-administered autoinjector [43][44] - Expected phase two data by the end of 2026, with comparisons to existing treatments [44] Financial Position - **Cash Reserves**: Approximately $525 million, sufficient to fund operations and milestones through 2028 [17] Additional Insights - The company has a strong focus on operational execution and has successfully accelerated timelines compared to competitors [19][22] - The strategic decision to include all patient types (refractory, stable, naive) in trials enhances recruitment and reflects a more inclusive approach [30][31] - The potential for upstream inhibition of pro-inflammatory cytokines (C3a, C3b) may lead to better efficacy outcomes compared to downstream inhibitors like C5 [40][42] This summary encapsulates the key points from the Dianthus Therapeutics FY Conference, highlighting the company's innovative approach to autoimmune therapeutics and its strategic positioning in the market.

Dianthus Therapeutics, Inc. (DNTH) came out with a quarterly loss of $0.97 per share versus the Zacks Consensus Estimate of a loss of $0.86. This compares to a loss of $0.74 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -12.79%. A quarter ago, it was expected that this company would post a loss of $0.86 per share when it actually produced a loss of $0.88, delivering a surprise of -2.33%.Over the last four quarters, the compa ...

Core Insights - Dianthus Therapeutics reported significant advancements in the clinical development of claseprubart, particularly in the Phase 2 MaGic trial for generalized Myasthenia Gravis (gMG), showing statistically significant improvements in MG-ADL and QMG scores at Week 13 [1][4][5] - The company has accelerated the timeline for the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to Q2 2026 due to faster enrollment [1][6] - An exclusive licensing agreement for DNTH212, a bifunctional BDCA2 and BAFF/APRIL inhibitor, was announced, with Phase 1 data expected in 2H 2026 [1][8][12] - Dianthus has an estimated cash position of approximately $525 million, providing financial runway into 2028 [1][18] Clinical Development Updates - Claseprubart demonstrated rapid and clinically meaningful improvements in gMG patients, with the 300mg/2mL Q2W dose showing significant efficacy across multiple endpoints [4][5] - The Phase 3 trial for claseprubart in gMG is anticipated to begin in 2026, with a focus on both 300mg/2mL Q2W and Q4W dosing [1][11] - The ongoing Phase 2 MoMeNtum trial for Multifocal Motor Neuropathy (MMN) is expected to yield top-line results in 2H 2026 [1][7] Financial Performance - For Q3 2025, Dianthus reported a net loss of $36.8 million, or $0.97 per share, compared to a net loss of $25.2 million, or $0.74 per share, in Q3 2024 [10][24] - Research and development expenses increased to $32.5 million in Q3 2025, driven by higher clinical costs and increased headcount [10][18] - General and administrative expenses rose to $8.2 million in Q3 2025, reflecting increased staffing [10][18] Corporate Strategy - The company aims to establish itself as a leader in the autoimmune disease treatment space, focusing on delivering best-in-class therapies with infrequent, subcutaneous self-administration [2][3] - The CEO emphasized the importance of executing their plans to advance both claseprubart and DNTH212 as transformative therapies for severe autoimmune diseases [2][3]

Core Insights - Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation therapies for severe autoimmune diseases [3] Company Participation in Conferences - The company will participate in four upcoming investor conferences, with CEO Marino Garcia hosting fireside chats and one-on-one investor meetings [1] - The specific conferences include: - Guggenheim 2nd Annual Healthcare Innovation Conference on November 11, 2025 - TD Cowen Immunology & Inflammation Summit on November 12, 2025 - Stifel 2025 Healthcare Conference on November 13, 2025 - Jefferies Global Healthcare Conference on November 17, 2025 [4] Company Overview - Dianthus Therapeutics is based in New York City and Waltham, Massachusetts, and is led by an experienced team of biotech and pharma executives [3] - The company's mission is to deliver transformative medicines for individuals suffering from severe autoimmune and inflammatory diseases [3]

Core Insights - Dianthus Therapeutics presented positive data from the Phase 2 MaGic trial for claseprubart in generalized Myasthenia Gravis (gMG), indicating potential for 300mg/2mL Q4W dosing [1][3][4] - A Phase 3 gMG trial is planned to start in 2026, including QMG ≥10 screening criteria and two treatment arms: 300mg/2mL Q2W and 300mg/2mL Q4W, compared to placebo [1][4][7] - New preclinical data suggest efficacy benefits of upstream (active C1s) versus downstream (C5) complement inhibition [1][5] Company Overview - Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation therapies for severe autoimmune diseases [3][9] - The company aims to build a neuromuscular franchise with claseprubart and plans to initiate a Phase 3 trial in gMG in 2026 [7][9] Clinical Data Highlights - The Phase 2 MaGic trial showed a robust decline in MG-ADL of -2.5 points at week 4 in the open-label extension, with a QMG score reduction of -3.2 points for placebo patients who received only two doses of claseprubart [5][6] - A subgroup analysis indicated a 3-point difference in MG-ADL treatment effect for patients with a QMG score ≥10 at baseline receiving 300mg/2mL Q2W [5][6] Future Outlook - The company is motivated to proceed to Phase 3 trials based on the impressive Phase 2 data and encouraging post hoc analyses [4][7] - Upcoming trials include the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy in the second half of 2026 and top-line data from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy [7]