FDA & Biotech

Dianthus Soars 65% on Positive Myasthenia Gravis Drug Trial Data

Phase 2 results for its claseprubart treatment showed rapid, meaningful improvement, boosting prospects for a best-in-class therapy.

Shares of Dianthus Therapeutics (NASDAQ: DNTH) surged more than 65% after the biotechnology firm announced positive results from a mid-stage trial for its experimental drug designed to treat generalized Myasthenia Gravis (gMG), a chronic autoimmune disorder.

The company reported that its drug, claseprubart, achieved statistically significant and clinically meaningful improvements in patients. According to the , the Phase 2 MaGic trial showed rapid efficacy, with patients showing improvement as early as the first week of treatment. The 300mg dose, which can be administered via a convenient self-injection, demonstrated a comparable treatment effect to a higher 600mg dose, reinforcing its potential as a best-in-class profile for patient use.

"The consistent and meaningful treatment effect seen in both treatment arms across multiple standard MG efficacy metrics in this Phase 2 trial gives me and my team great confidence in our ability to execute a successful Phase 3 trial," said Simrat Randhawa, MD, Chief Medical Officer of Dianthus Therapeutics. The treatment also exhibited a favorable safety profile with no drug-related serious adverse events reported.

The news , reflecting strong investor optimism about the drug's prospects. The results also drew immediate praise from , with firms like Guggenheim reiterating a 'Buy' rating and identifying Dianthus as a 'Top Pick,' raising its price target to $92.

Myasthenia Gravis is a debilitating neuromuscular disease that causes significant muscle weakness. Dianthus's claseprubart is an enhanced monoclonal antibody designed to selectively inhibit the classical complement pathway, a key driver of the disease. Following the successful trial, Dianthus plans to meet with the FDA to align on a Phase 3 trial design, which it anticipates initiating in 2026, investigating both bi-weekly and monthly dosing regimens.