Dianthus Therapeutics Inc. (NASDAQ:DNTH) reported a fourth-quarter loss of $1.43 per share on Monday, while revenue totaled $280 thousand for the quarter ended December 31, 2025.
Shares of the biotechnology company surged 25.05% in pre-market trading following the announcement.
The company revealed it had reached an early GO decision in its Phase 3 CAPTIVATE trial evaluating claseprubart for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The milestone was achieved after the study recorded 20 confirmed responders, with fewer than 40 of the planned participants completing the open-label Part A stage.
The early GO determination came ahead of the previously expected second-quarter 2026 timeline and was based on trial criteria requiring a response rate of at least 50%. Dianthus said it expects to release guidance for the CAPTIVATE Part B top-line results by the end of 2026.
“It is truly exciting to be part of a company developing potential best-in-disease therapies for patients suffering from severe autoimmune diseases,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics.
For the full year 2025, Dianthus reported a net loss of $162.3 million, or $4.20 per share, compared with a net loss of $85.0 million, or $2.55 per share, in 2024.
Research and development expenses rose to $145.6 million from $83.1 million year over year, primarily due to higher clinical trial costs and upfront milestone payments related to DNTH212.
As of December 31, 2025, the company held $514.4 million in cash, cash equivalents and investments, which it expects will fund operations through 2028.
Dianthus also plans to launch a Phase 3 registrational study of claseprubart in generalized Myasthenia Gravis in mid-2026, with top-line results anticipated in the second half of 2028.