Marisa Wexler, MS, senior science writer —

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application from Kyverna Therapeutics, giving the company the go-ahead to launch a Phase 2 clinical trial that will test its cell therapy, KYV-101, in people with myasthenia gravis (MG). This is the fifth IND…

The U.S. Food and Drug Administration (FDA) has given Cabaletta Bio the go-ahead to launch a Phase 1/2 clinical trial testing its cell therapy CABA-201 in people with generalized myasthenia gravis (gMG). The upcoming trial is expected to enroll a dozen adults with gMG — six who are positive…

The U.S. Food and Drug Administration (FDA) has approved zilucoplan, a once-daily injection therapy to now be marketed under the brand name Zilbrysq, for adults with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR). With this approval, Zilbrysq has now become the…

A treatment based on GRO Biosciences‘ ProGly program — which uses specially designed proteins to regulate the immune system — substantially reduced disease activity in an animal model of myasthenia gravis (MG), according to new data presented by the company. “We are greatly encouraged by the results of…

UCB’s zilucoplan and Rystiggo (rozanolixizumab) both were approved in Japan to treat adults with generalized myasthenia gravis (gMG) who lack an adequate response to steroids or other immunosuppressive treatments. “With the approval in Japan of zilucoplan and [Rystiggo], we are very proud and excited to expand our…

Treatment with the experimental therapy povetacicept (ALPN-303) reduced disease activity in a mouse model of myasthenia gravis (MG), according to data shared by its developer, Alpine Immune Sciences. Povetacicept also was tolerated well by healthy volunteers participating in a Phase 1 clinical trial. “Together, these data provide strong…

Elderly people with myasthenia gravis (MG) are at higher risk of experiencing side effects related to disease treatments, which can be fatal for patients in some cases, a new study found. In fact, treatment-related adverse effects were seen among more than 40% of patients in the study —…

Soliris (eculizumab), already approved in Japan for adults with generalized myasthenia gravis (gMG), has now become the first therapy to win approval in the Asian nation for treating children and adolescents with this type of the autoimmune condition. The expanded use was granted by the Japanese Ministry of…

The approval of Soliris (eculizumab) in the European Union now extends to children and adolescents, ages 6 to 17, with generalized myasthenia gravis (gMG). The European Commission decision covers Soliris’ use in children who have refractory disease, meaning they have failed to respond to standard treatments, and are…

A branch of the European Medicines Agency (EMA) recommended that the approval of Soliris (eculizumab) be expanded to include children and adolescents, ages 6 to 17, with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR) — the most common type of MG-driving…