Immunovant Announces Topline Results from Proof-of-Concept Study of IMVT-1402 in Cutaneous Lupus Erythematosus
IMVT-1402 missed its primary endpoint in CLE, prompting Immunovant to halt CLE development while continuing other autoimmune trials.
Rhea-AI Summary
Immunovant (IMVT) reported topline results from Period 1 of its proof-of-concept trial of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE), where the study did not achieve statistical significance on the primary endpoint of CLASI-A percent change from baseline at Week 12.
Numerical trends favored IMVT-1402 over placebo on multiple endpoints, and patients with deeper IgG reductions were more likely to show improved clinical responses, but these results did not meet the company’s internal bar to continue IMVT-1402 development in CLE. IMVT-1402 showed a favorable safety and tolerability profile consistent with prior studies, and the company stated that all other clinical development timelines for IMVT-1402 in autoimmune diseases such as Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease remain on track.
Positive
- Favorable safety profile for IMVT-1402, consistent with prior studies
- Company states all other IMVT-1402 clinical timelines across multiple autoimmune diseases remain on track
- Numerical efficacy trends favoring IMVT-1402 over placebo on multiple endpoints
Negative
- CLE proof-of-concept trial failed to reach statistical significance on the primary CLASI-A endpoint at Week 12
- Immunovant plans to stop development of IMVT-1402 in cutaneous lupus erythematosus
News Explained
Immunovant says it plans to stop IMVT-1402 development in CLE; this is a stated future plan, not confirmation that the program has already been discontinued, so the indication’s development status changes only if the plan is carried out.
Details
Market Reaction – IMVT
On Sep 23, the day this news came out, the latest delayed price for IMVT is 9.64% below the previous close. Our momentum scanner has recorded 7 alerts for this stock so far that day. The latest delayed price is $33.70. Relative volume is exceptionally heavy at 6.7x the average.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Key Terms
cutaneous lupus erythematosus medical
clasi-a medical
igg medical
fcrn medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Immunovant’s proof-of-concept study of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12
- Positive trends were observed on multiple endpoints, with deeper IgG reductions resulting in improved clinical outcomes, but the study did not meet Immunovant’s internal bar to continue development of IMVT-1402 in CLE
- IMVT-1402 demonstrated a favorable safety and tolerability profile, consistent with prior studies
- All other clinical development timelines remain on track
DURHAM, N.C., Sept. 23, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT) today announced topline results from Period 1 of its proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE).
The study did not achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. Numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE.
“On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care. Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward,” said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant.
Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402 across multiple autoimmune diseases with significant unmet need, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease.
About the Proof-of-Concept Study of IMVT-1402 in CLE
The proof-of-concept clinical study (NCT06980805) of IMVT-1402 (imeroprubart) in CLE is a randomized, double-blind, placebo-controlled, global trial that assessed the safety and efficacy of IMVT-1402 in adult patients with CLE. The study enrolled 57 patients. In Period 1, patients were randomized to IMVT-1402 vs. placebo for a 12-week treatment period. The primary endpoint was the percent change from Period 1 baseline in CLASI-A score at Week 12.
About Immunovant
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com.
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding Immunovant’s plans and progress towards developing IMVT-1402 across a broad range of indications. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, regulatory strategy, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402; Immunovant is at various stages of clinical development for IMVT-1402; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 20, 2026, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com
Media
Stephanie Lee
stephanie.lee@roivant.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.