Immunovant has stopped development of its anti-FcRn antibody IMVT-1402 for cutaneous lupus erythematosus (CLE) after the therapy failed to meet the primary endpoint in a proof-of-concept midstage clinical trial. The decision ends one potential indication for the drug, although the company plans to continue development in several other autoimmune diseases.
The biotechnology company evaluated IMVT-1402, also known as imeroprubart, in a placebo-controlled study involving 57 adults with CLE. After 12 weeks of treatment, the trial did not show a statistically significant improvement over placebo on its primary endpoint, resulting in the study missing its main goal.
Trial Findings and Decision to End CLE Program
The study assessed IMVT-1402 in patients with cutaneous lupus erythematosus, an autoimmune disease that primarily affects the skin and can cause rashes, redness and inflammation.
Although the trial did not achieve its primary endpoint, Immunovant reported numerical trends favoring IMVT-1402 across multiple measures. The company also found evidence that patients who experienced deeper reductions in IgG antibodies from baseline were more likely to respond to treatment.
Despite those findings, Immunovant decided not to continue development in CLE. The company said the decision was influenced by both the clinical results and the treatment landscape for the disease.
Immunovant said it plans to discontinue development in CLE because of the “competitive landscape.”
Other Companies Continue Advancing Lupus Treatments
The CLE treatment field remains active, with several companies advancing therapies that use different mechanisms of action.
In March, Biogen reported positive midphase results for its anti-BDCA2 antibody litifilimab in CLE. AstraZeneca and Merck KGaA are conducting phase 3 trials in the disease, evaluating a type I interferon receptor inhibitor and a Toll-like receptor 7 and 8 (TLR7/8) inhibitor, respectively. Beeline is also preparing to advance its TLR7/8 inhibitor into phase 3 development.
Beyond CLE, FcRn-targeting therapies continue to be studied in lupus. Johnson & Johnson reported a phase 2 win for its FcRn blocker Imaavy in systemic lupus erythematosus in January and has moved the candidate into a pivotal development program.
Broader IMVT-1402 Development Continues
While development in CLE has been halted, IMVT-1402 remains Immunovant’s lead drug candidate. The company is continuing development in Graves’ disease, rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease.
Immunovant expects topline data from potentially registrational studies in Graves’ disease and myasthenia gravis in 2027. Data from studies in chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease are expected in 2028.
The company also reported that IMVT-1402 demonstrated a favorable safety and tolerability profile in the CLE study.
Analysts’ View and Market Response
Prior to the results, Guggenheim Securities analysts said they were cautious about the readout after hearing Immunovant executives describe the CLE study as a “fact-finding proof-of-concept” trial in a competitive landscape.
Following the announcement, Immunovant shares fell about 6% in Wednesday premarket trading, declining to around $35 from a Tuesday closing price of $37.29.
As of June 30, Immunovant reported $797.8 million in cash and cash equivalents, compared with $902.1 million at the end of March. The company said its current resources are expected to fund operations through a potential commercial launch of IMVT-1402 in Graves’ disease.
Immunovant has decided to discontinue development of IMVT-1402, also known as imeroprubart, in cutaneous lupus erythematosus (CLE) after a proof-of-concept study failed to achieve statistical significance on its primary endpoint. The decision was announced on September 23, 2026, following topline results from the trial.
The randomized, double-blind, placebo-controlled global study enrolled 57 adults with cutaneous lupus. During the first 12-week treatment period, participants received either IMVT-1402 or placebo. The primary endpoint measured the percentage change from baseline in the CLASI-A score at Week 12, a measure used to assess disease activity in cutaneous lupus.
Immunovant Trial Misses Primary Endpoint
The study did not show a statistically significant difference on its primary endpoint. Immunovant reported numerical trends favoring IMVT-1402 across several additional measures, but the results did not meet the company’s internal criteria for continuing development in CLE.
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