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.（納斯達克: IMVT）是一家臨床階段的免疫學公司，致力於使患有自身免疫性疾病的人們能夠過上正常的生活。今天，Immunovant報告了巴托克利麥在格雷夫斯病的2期臨床試驗的積極結果。Immunovant還公佈了幾項專有市場研究數據，顯示在對甲狀腺調節素治療無法耐受、無法控制或復發的患者中存在一致的未滿足需求。最後，Immunovant還宣佈與美國食品藥品監督管理局（FDA）達成一致，並獲得了IMVt-1402對格雷夫斯病的關鍵試驗的新藥研究申請（IND）的通過批准，預計將於2024年12月31日啓動。
譯文內容由第三人軟體翻譯。