Immunovant, Inc. saw its stock climb 20% on Wednesday after releasing preliminary Week 16 results from the IMVT-1402 program in a cohort of patients with difficult-to-treat rheumatoid arthritis.
The company reported that in the open-label portion of the IMVT-1402 trial, observed response rates at Week 16 were an ACR20 of 72.7%, an ACR50 of 54.5% and an ACR70 of 35.8%. The study enrolled 170 participants characterized by prior treatment failure - each had failed two or more mechanisms of advanced therapies.
At the end of Period 1, 165 of the 170 patients were evaluable for ACR20 response. Within this evaluable population, 86.7% had failed two prior mechanisms of advanced therapies, and the mean time since rheumatoid arthritis diagnosis was 12.8 years. Baseline disease activity was described as high, with mean tender joint counts of 24.2, mean swollen joint counts of 16.7, and a mean DAS28-CRP score of 6.1.
Immunovant provided response rates for an especially treatment-resistant subset as well. Among participants who had previously failed at least a JAK inhibitor and an anti-TNF inhibitor, the observed Week 16 response rates were an ACR20 of 72.0%, an ACR50 of 53.3% and an ACR70 of 37.4%.
The company stated that IMVT-1402 was safe and well-tolerated in the study and that no new drug-related safety signals were identified in these data. Immunovant indicated it expects to share additional updates on the program in the second half of calendar year 2026.
Parallel clinical activity for IMVT-1402 was also reported. The company said the IMVT-1402 proof-of-concept trial in cutaneous lupus erythematosus is fully enrolled and that topline data for that trial are expected in the second half of calendar year 2026. Management added that clinical development timelines for IMVT-1402 remain on track and include potential registrational studies in Graves' disease, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjögren's disease.
On the financial side, Immunovant reported a net loss of $147.9 million, or $0.73 per share, for the fourth quarter ended March 31, 2026. That compares with a net loss of $106.4 million, or $0.64 per share, for the same period a year earlier. As of March 31, 2026, the company held approximately $902.1 million in cash and cash equivalents.
Summary of key developments
- IMVT-1402 delivered Week 16 ACR20/50/70 rates of 72.7%, 54.5% and 35.8% in an open-label cohort of difficult-to-treat rheumatoid arthritis patients.
- Study population included 170 enrolled patients, 165 evaluable for ACR20 at Period 1 completion, with high baseline disease activity and an average disease duration of 12.8 years.
- The therapy was reported to be safe and well-tolerated; additional program updates and topline data for a cutaneous lupus proof-of-concept trial are expected in the second half of calendar year 2026.
Context on clinical scope and finances
The trial data highlight responses in a population with multiple prior therapy failures, including a subgroup that had failed both a JAK inhibitor and an anti-TNF agent. Separately, the company reiterated plans for broader IMVT-1402 development across several autoimmune indications and indicated that its clinical timelines remain on track. On a balance-sheet basis, Immunovant reported a widened quarterly net loss and held roughly $902.1 million in cash and equivalents as of the end of March 2026.
Note on data and next steps
These results are preliminary and were disclosed from the open-label portion of the study. Immunovant has signaled further communications on the program and expects additional clinical readouts in the second half of calendar year 2026.