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Dianthus Therapeutics, Inc. (Nasdaq: DNTH) is a clinical-stage biotechnology company dedicated to the design and delivery of novel monoclonal antibodies with enhanced selectivity and potency. The company's primary focus is on developing next-generation complement therapeutics aimed at treating severe autoimmune and inflammatory diseases. With a seasoned team of biotech and pharma executives, Dianthus Therapeutics is at the forefront of innovation in complement therapies.
The company's flagship product, DNTH103, is an investigational active C1s inhibitor. This potent monoclonal antibody is engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein. Enhanced with YTE half-life extension technology, DNTH103 is designed for convenient subcutaneous, self-administered injections dosed as infrequently as once every two weeks. This selective inhibition promises to lower patient risk of infection while maintaining immune activity of the lectin and alternative pathways.
One of the latest milestones for Dianthus Therapeutics is the initiation of the Phase 2 MaGic trial of DNTH103 in patients with generalized Myasthenia Gravis (gMG). The trial, which began following FDA clearance, aims to evaluate the safety, tolerability, and efficacy of DNTH103. The randomized, double-blind, placebo-controlled study includes up to 60 patients who are acetylcholine receptor (AchR) antibody positive. Following an initial loading dose, DNTH103 is administered every two weeks via subcutaneous injection for 12 weeks, with an option for a 52-week open-label extension. The primary endpoint is safety and tolerability, with secondary endpoints including assessments using the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores. Initial top-line results are anticipated in the second half of 2025.
Dianthus Therapeutics is also making strides in other areas. The company plans to initiate additional Phase 2 trials in 2024 for other neuromuscular indications such as Multifocal Motor Neuropathy and Chronic Inflammatory Demyelinating Polyneuropathy. The aim is to build a comprehensive neuromuscular franchise around DNTH103, leveraging its unique capabilities and potential as a best-in-class treatment option.
Financially, 2023 was a transformative year for Dianthus, marked by its transition to a public company and the successful completion of a $230 million PIPE financing. This financial runway extends into the second half of 2027, providing the company with the resources needed to achieve key milestones and data readouts in the coming years.
For more information, visit Dianthus Therapeutics and follow them on LinkedIn.
Disclaimer: Certain statements in this description may constitute forward-looking statements within the meaning of federal securities laws. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially.
Dianthus Therapeutics (NASDAQ: DNTH) reported Q3 2024 financial results and business updates. The company plans to initiate a pivotal Phase 3 trial of DNTH103 in CIDP by year-end 2024, while Phase 2 trials in gMG and MMN are ongoing with results expected in 2H'25 and 2H'26, respectively. Financial highlights include $342.6 million cash position providing runway into 2H'27, Q3 R&D expenses of $25.5 million, and a net loss of $25.2 million ($0.74 per share). DNTH103, their lead candidate, is designed for subcutaneous administration every two weeks in treating autoimmune disorders.
Dianthus Therapeutics (Nasdaq: DNTH) has announced its participation in three major healthcare investor conferences. CEO Marino Garcia will present corporate overviews at the Guggenheim Healthcare Innovation Conference (November 11, 1:30 p.m. ET, Boston), Jefferies Global Healthcare Conference (November 19, 9:00 a.m. GMT, London), and 7th Annual Evercore HealthCONx Conference (December 4, 10:50 a.m. ET, Coral Gables). Live webcasts will be available on the company's website under the Investors section.
Dianthus Therapeutics (Nasdaq: DNTH) announced two poster presentations for DNTH103 at the 2024 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting in Savannah, Georgia. DNTH103 is an investigational classical pathway inhibitor specific to the active form of C1s, being evaluated for generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy.
The presentations will showcase:
- Preclinical and in vitro data on DNTH103's potentially differentiated profile in disease models of gMG and CIDP
- Head-to-head affinity and pharmacodynamic potency data comparing DNTH103 to riliprubart
- DNTH103's sustainable inhibition of complement and prevention of nerve conduction velocity impairment in a CIDP preclinical model
- DNTH103 as a potentially safer and more convenient novel therapy for generalized Myasthenia Gravis
The posters will be available on the Dianthus website after presentation.
Dianthus Therapeutics (Nasdaq: DNTH), a clinical-stage biotech company focused on developing advanced antibody complement therapeutics for severe autoimmune diseases, has announced its participation in three major healthcare investor conferences in September 2024. CEO Marino Garcia will present corporate overviews at:
1. Baird 2024 Global Healthcare Conference on September 11 at 2:00 p.m. ET in New York City
2. Cantor 2024 Global Healthcare Conference on September 17 at 10:55 a.m. ET in New York City
3. Stifel 2024 Virtual Immunology and Inflammation Summit on September 18 at 10:30 a.m. ET via Zoom
Live webcasts of the Cantor and Stifel conference presentations will be available on the company's website under the Investors section.
Dianthus Therapeutics (Nasdaq: DNTH) reported Q2 2024 financial results and business updates. Key highlights include:
- Phase 2 MaGic trial in generalized Myasthenia Gravis (gMG) ongoing; top-line results expected in 2H'25
- IND cleared for Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy (MMN); top-line results anticipated in 2H'26
- Phase 2 trial in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to start 2H'24
- $360.7 million cash position, providing runway into 2H'27
- Q2 2024 net loss of $17.6 million or $0.51 per share
- R&D expenses increased to $18.1 million, G&A expenses rose to $6.0 million
DNTH103, the company's lead candidate, is advancing in multiple autoimmune indications with potential for best-in-class profile.
Dianthus Therapeutics announced two poster presentations for DNTH103 at the 10th Congress of the European Academy of Neurology, held in Helsinki from June 29 to July 2, 2024. DNTH103 is an investigational inhibitor targeting the active form of C1s, being evaluated for the treatment of severe neuromuscular conditions like generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy. The presentations will showcase preclinical and in vitro data, highlighting DNTH103's potential advantages over existing treatments. The CEO emphasized DNTH103's potential for safer, more convenient administration with consistent symptom control and fewer risks compared to current therapies.
Dianthus Therapeutics has received FDA clearance to start a Phase 2 trial for DNTH103 in treating Multifocal Motor Neuropathy (MMN). This trial, named the MoMeNtum study, will assess the safety, tolerability, and efficacy of DNTH103 in 36 patients globally. The trial will follow a randomized, double-blind, placebo-controlled design, with patients receiving subcutaneous injections every two weeks for 17 weeks, followed by a 52-week open-label extension. Top-line results are expected in the second half of 2026. DNTH103, a potent C1s inhibitor, aims to offer a more convenient treatment option than current therapies. Dianthus is also building a neuromuscular franchise with planned trials in generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy in 2024.
Dianthus Therapeutics, a biotechnology company focused on antibody complement therapeutics for autoimmune diseases, will participate in the Jefferies Global Healthcare Conference.
The company’s CEO, Marino Garcia, will present a corporate overview on June 6, 2024, at 1:30 p.m. ET in New York.
A live webcast of the presentation will be accessible via the Investors section of Dianthus Therapeutics' website.
Dianthus Therapeutics, a clinical-stage biotech company, reported financial results for Q1 2024, highlighting the initiation of Phase 2 MaGic trial for gMG using DNTH103, with ongoing trials in MMN and CIDP. The company raised $377 million in cash through successful financing, projecting runway till 2027.
Dianthus Therapeutics, a clinical-stage biotechnology company, will participate in the Bank of America Securities 2024 Health Care Conference. The CEO will present a corporate overview, focusing on antibody complement therapeutics for severe autoimmune diseases.
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