Workflow
IMVT Stock Up on Upbeat Data From Graves' Disease Study of Batoclimab
ImmunovantImmunovant(US:IMVT) ZACKSยท2024-09-09 13:35

Core Viewpoint - Immunovant's shares are rising following positive mid-stage study results for batoclimab, an investigational candidate for Graves' Disease (GD) [1] Group 1: Study Results - The phase IIa study involved uncontrolled GD patients who were hyperthyroid despite anti-thyroid drug (ATD) therapy, with a high dose of batoclimab (680 mg weekly) administered for 12 weeks, followed by a lower dose (340 mg weekly) for another 12 weeks [2] - The high-dose treatment resulted in a mean Immunoglobulin G (IgG) reduction of 77%, with a response rate of 76% after 12 weeks; 56% of patients achieved an ATD-Free Response [3] - During the subsequent 12 weeks on the lower dose, mean IgG levels were further reduced by 65%, with a responder rate of 68% and an ATD-Free Response rate dropping to 36% [4] Group 2: Market Opportunity - Real-world claims data indicates that 25-30% of GD patients remain uncontrolled on ATDs annually, highlighting a significant unmet need and commercial opportunity for Immunovant with limited competition [5][6] - The company plans to initiate a pivotal study for IMVT-1402, a fully-human monoclonal antibody for GD, by the end of 2024, having aligned with the FDA on the study design [6][7] Group 3: Future Development Plans - Immunovant is conducting mid to late-stage studies for batoclimab in other autoimmune diseases, including Myasthenia gravis and thyroid eye disease, with plans to study IMVT-1402 for these indications based on positive data [8] - The company aims to initiate four to five registrational programs for IMVT-1402 over the next fiscal year, targeting a total of 10 indications in the following two fiscal years [9]