Investigational therapy batoclimab eased disease severity for adults with generalized myasthenia gravis (gMG) in a Phase 3 trial, but the treatment’s developer said it’s not planning to seek regulatory approval of the treatment for gMG in the U.S. Immunovant, a Roivant subsidiary, is instead focused on using the…

Immunovant is moving forward with its Phase 3 clinical trial in the U.S. to evaluate the investigational myasthenia gravis (MG) therapy batoclimab in the first half of this year. The announcement came after the company reached an agreement with the division of neurology within the U.S. Food…

Immunovant will use a $200 million strategic investment from Roivant Sciences to advance IMVT-1401, its investigational therapy for myasthenia gravis (MG) and other autoimmune conditions. A pivotal clinical trial testing IMVT-1401 in people with MG is expected to be launched within the next 12 months, according to…

Harbour BioMed’s investigational therapy batoclimab (HBM9161) safely and rapidly eases symptoms and lowers the levels of harmful antibodies in adults with moderate-to-severe generalized myasthenia gravis (gMG), according to top-line data from a Phase 2 clinical trial in China. “The strong evidence generated from this study is quite exciting…

Following a review of available clinical data, Immunovant has announced plans to resume clinical testing of the investigational medication IMVT-1401 in myasthenia gravis (MG) and other autoimmune conditions. Following discussions with regulatory agencies, the company is planning to launch a potentially pivotal trial of IMVT-1401 in…

Treatment with IMVT-1401 significantly eased symptoms and lowered antibody levels in adults with moderate-to-severe generalized myasthenia gravis (MG), top-line results of a small Phase 2a trial show. Use of this investigative antibody at two doses was also seen to be safe and well tolerated. Results are expected to…

Immunovant is preparing to launch a Phase 3 trial of its investigational candidate IMVT-1401 in patients with myasthenia gravis (MG); it may lead to the treatment’s approval for this indication, pending positive results. The new trial will build on data from two previous studies of other drug candidates that…