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NEW YORK and WALTHAM, Mass. - Dianthus Therapeutics, Inc. (NASDAQ: DNTH), a biotech firm focused on antibody complement therapeutics for autoimmune diseases, has announced the completion of patient enrollment for its Phase 2 MaGic trial. With a market capitalization of $697 million and a robust current ratio of 15.22, InvestingPro data shows the company maintains strong financial health with more cash than debt on its balance sheet. The trial is evaluating the efficacy of DNTH103 in individuals with generalized Myasthenia Gravis (gMG), a condition characterized by muscle weakness.
The MaGic trial, which is randomized, double-blind, and placebo-controlled, recruited 65 participants, surpassing its target of 60. DNTH103, a monoclonal antibody designed to selectively inhibit the C1s protein, is being tested for safety, tolerability, and its impact on daily living activities and disease severity in gMG patients.
Top-line results from the trial are expected in September 2025, with the company’s next earnings report scheduled for May 8, 2025. The primary focus of the trial is to assess the safety and tolerability of DNTH103, with secondary endpoints including improvements in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and the Quantitative Myasthenia Gravis (QMG) score. Analyst price targets range from $36 to $84, reflecting strong confidence in the company’s potential. InvestingPro subscribers have access to 8 additional key insights about DNTH’s financial outlook.
DNTH103 has been engineered to selectively target the classical pathway of the immune system, which is believed to play a significant role in the pathology of gMG. Approximately 85% of the over 100,000 gMG patients in the U.S. have a form of the disease driven by AChR autoantibodies.
The company aims to position DNTH103 as a potential first-line therapy that may offer benefits over current treatments, including continuous symptom control, a lower risk for infections, and more convenient dosing. The drug is intended to be self-administered via injection every two weeks.
In addition to the MaGic trial, DNTH103 is undergoing evaluation in Phase 3 and Phase 2 trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN), respectively, with interim and top-line results expected in the second half of 2026.
This announcement is based on a press release statement from Dianthus Therapeutics. While the company has not yet received approval for DNTH103 as a therapy in any indication, and the outcomes of ongoing trials are eagerly anticipated by the medical community and patients alike, investors should note that according to InvestingPro analysis, the stock is currently trading slightly above its Fair Value, with analysts anticipating a sales decline in the current year.
In other recent news, Dianthus Therapeutics reported fourth-quarter revenue of $1.33 million, which did not meet analyst expectations. The company posted a quarterly loss of $0.81 per share. Despite this, Dianthus continues to make progress in its clinical trials, including its lead candidate, DNTH103. The company is on track to report top-line data from its Phase 2 trial in generalized Myasthenia Gravis in the second half of 2025. Additionally, the Phase 3 CAPTIVATE trial for Chronic Inflammatory Demyelinating Polyneuropathy is progressing, with an interim responder analysis expected in the second half of 2026. For the full year 2024, research and development expenses increased to $83.1 million, up from $32.8 million in 2023, reflecting higher clinical and manufacturing costs. General and administrative expenses also rose to $25.0 million from $18.2 million the previous year. Dianthus ended 2024 with a cash position of $357.0 million, which is expected to support operations into the second half of 2027.
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