Dianthus Delays CAPTIVATE Part B Readout to Year-End 2028

The Tip Desk · November 11, 2026 · 3 min read

The company now projects fewer than 200 open-label patients to randomize 128 responders, with Part A data by year-end 2027, after a $46.6 million third-quarter net loss.

Dianthus Therapeutics (DNTH) said its Phase 3 CAPTIVATE trial of claseprubart in chronic inflammatory demyelinating polyneuropathy is now conservatively projected to require fewer than 200 participants in open-label Part A to randomize 128 responders into placebo-controlled Part B, with Part A top-line results expected by year-end 2027 and Part B by year-end 2028.

That timeline slipped from the company’s August update, which had pointed to Part B top-line results by year-end 2026. An interim responder analysis of the first 40 participants completing Part A still showed a 75% response rate, exceeding the 50% target the company set from prior aC1s-inhibition precedent. Claseprubart was generally well tolerated in that interim readout, with no related serious infections, no clinical symptoms of drug-induced lupus, no related serious adverse events, and no safety-related discontinuations.

The clinical-stage biotechnology company reported a net loss of $46.6 million, or $0.81 a share, for the quarter ended September 30, 2026, compared with a $36.8 million loss, or $0.97 a share, a year earlier. Weighted-average shares used in the per-share calculation were 57.34 million.

Research and development expenses were $45.6 million, including $6.3 million of stock-based compensation, versus $32.5 million a year earlier, including $2.5 million of stock-based compensation. The company said the increase was primarily driven by higher clinical costs and increased headcount to support claseprubart Phase 2 and Phase 3 development, plus costs related to DNTH212 and DNTH312. General and administrative expenses were $14.1 million, including $6.4 million of stock-based compensation, versus $8.2 million a year earlier, primarily due to increased headcount. License revenue was $1.21 million.

Cash, cash equivalents and investments were approximately $1.2 billion as of September 30, 2026, matching the June 30 and March 31 levels and still projected to provide runway into 2030.

The Phase 3 EMERGE registrational trial of claseprubart in generalized myasthenia gravis, which began in June, remains on track for top-line results in the second half of 2028. Phase 2 MaGic open-label extension data presented at AANEM showed sustained efficacy and a continued favorable safety profile.

The Phase 2 MoMeNtum trial in multifocal motor neuropathy exceeded its original enrollment target of 36 patients; top-line results with 46 patients are on track for December 2026. Following those results, the company plans to initiate a Phase 3 trial in MMN in 2027. Chief Executive Officer Marino Garcia said MMN is a significant market opportunity with limited competition and that IVIg is the only approved treatment.

DNTH212 advanced on two fronts. Dosing of the first SLE patient in Part B of the Phase 1 single ascending dose study in China began in October, with preliminary Part B results expected in the second half of 2027. A Dianthus-led multiple ascending dose study outside China is planned to start in the second quarter of 2027, with preliminary data expected in the second half of 2027. Preliminary healthy-volunteer data from Part A are expected in the first quarter of 2027. The company plans an update on next steps for Sjögren’s disease, SLE and dermatomyositis by year-end 2027.

DNTH312, an internally developed bifunctional fusion protein combining claseprubart and TACI, is on track to be Phase 1 ready by year-end 2027.