Immunovant Reports Phase 2a Results for Graves' Disease Drug, FDA Clears Pivotal Trial
Immunovant Reports Phase 2a Results for Graves' Disease Drug, FDA Clears Pivotal Trial
Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported positive results from the Phase 2a trial of batoclimab in Graves' Disease. Immunovant also disclosed data from several proprietary market research studies that showed a consistent unmet need among ATD treated patients who are intolerant to, uncontrolled on or relapsed after ATDs. Finally, Immunovant also announced alignment with the U.S. Food & Drug Administration (FDA) and Investigational New Drug Application (IND) clearance with initiation of a pivotal trial of IMVT-1402 in GD expected by December 31, 2024.
Immunovant, Inc.（纳斯达克: IMVT）是一家临床阶段的免疫学公司，致力于使患有自身免疫性疾病的人们能够过上正常的生活。今天，Immunovant报告了巴托克利麦在格雷夫斯病的2期临床试验的积极结果。Immunovant还公布了几项专有市场研究数据，显示在对甲状腺调节素治疗无法耐受、无法控制或复发的患者中存在一致的未满足需求。最后，Immunovant还宣布与美国食品药品监督管理局（FDA）达成一致，并获得了IMVt-1402对格雷夫斯病的关键试验的新药研究申请（IND）的通过批准，预计将于2024年12月31日启动。