Shares of Immunovant, Inc. (IMVT), a clinical-stage biopharmaceutical company, are tumbling 43 percent or $18.62 in Tuesday’s morning trade at $24.68.
Tuesday, Immunovant announced a voluntary pause of dosing in its ongoing clinical trials for IMVT-1401. The company said it has become aware of a physiological signal consisting of elevated total cholesterol and LDL levels in IMVT-1401-treated patients in ASCEND GO-2, a Phase 2b trial in Thyroid Eye Disease or TED. Cholesterol levels were not measured in prior clinical trials of IMVT-1401 in Myasthenia Gravis (MG) and in healthy subjects.
Immunovant said that out of an abundance of caution, it has decided to voluntarily pause dosing in ongoing clinical studies in both TED and in Warm Autoimmune Hemolytic Anemia, in order to inform patients, investigators, and regulators as well as to modify the monitoring program.
Immunovant said it will work closely with regulators and scientific experts to characterize the detailed profile of these lipid changes and to understand the mechanism of these changes across indications. After agreement with regulators regarding protocol modifications, the company intends to continue to pursue development of IMVT-1401.
Immunovant has traded in a range of $8.34 to $53.75 in the past 52 weeks.
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