Immunovant reports promising Phase 3 MG study results

Published 19/03/2025, 12:50
Immunovant reports promising Phase 3 MG study results

NEW YORK - Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage immunology company with a market capitalization of $7.65 billion, today announced positive results from a Phase 3 study of its drug batoclimab in patients with Myasthenia Gravis (MG) and initial results from a Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). According to InvestingPro analysis, the company appears slightly undervalued based on its Fair Value assessment, with strong financial health indicators despite being pre-revenue. The studies showed that higher doses of batoclimab led to significant improvements in clinical outcomes for patients with these autoimmune diseases. This development comes as InvestingPro data shows the company maintains a healthy balance sheet with more cash than debt and a robust current ratio of 37.9x, providing ample runway for its clinical programs.

In the MG study, participants receiving 680mg of batoclimab weekly experienced a 5.6 point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 12, while those on a 340mg dose saw a 4.7 point improvement. The results indicated a correlation between deeper immunoglobulin G (IgG) reduction and better clinical outcomes. In CIDP, initial results showed a mean improvement in the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score of 1.8 across batoclimab arms, with an 84% responder rate in patients who achieved an IgG lowering greater than 70%.

The company noted that safety and tolerability were consistent with prior studies of batoclimab. Despite these promising results, Immunovant does not currently plan to seek regulatory approval for batoclimab in MG or CIDP. Instead, the focus is on advancing IMVT-1402, another anti-FcRn inhibitor, which is expected to enter pivotal studies for MG and CIDP imminently. The decision on regulatory submissions for batoclimab will be deferred until the results of ongoing Phase 3 studies in thyroid eye disease are available.

Immunovant’s CEO, Pete Salzmann, M.D., expressed optimism about the potential of deeper IgG reduction to improve clinical outcomes in a range of auto-antibody mediated conditions. The company will host an investor call today to discuss these updates further.

This news is based on a press release statement and reflects the company’s current expectations and preliminary analyses from ongoing clinical trials. Immunovant’s product candidates are still in the clinical development stage, and their commercial success will depend on future trial outcomes and regulatory approvals. While the company posted a revenue growth of 140% in the last twelve months, analysts tracked by InvestingPro maintain a strong buy consensus with a significant upside potential. For deeper insights into Immunovant’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, along with 11 additional ProTips and extensive financial metrics.

In other recent news, Roivant Sciences Ltd. announced changes in its executive team with the appointment of Jennifer Humes as the new Principal Accounting Officer. This follows the departure of Rakhi Kumar from her role as Principal Accounting Officer and Chief Accounting Officer of Roivant Sciences, Inc. Humes joins Roivant Sciences with a wealth of experience, having previously held senior positions at JPMorgan Chase, Citigroup, and Deloitte. Her compensation package includes an annual base salary of $380,000, a sign-on bonus of $261,500, and a target annual cash bonus of $190,000, along with restricted stock units and options. These financial terms are part of the company’s 2021 Equity Incentive Plan, with vesting conditions tied to her continued employment. Roivant Sciences has expressed appreciation for Kumar’s contributions and anticipates Humes’ impact in her new position. The company continues to focus on its strategic goals in the pharmaceutical sector.

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