News

Kyverna Therapeutics is planning to launch a Phase 3 clinical trial testing its experimental cell therapy KYV-101 in people with myasthenia gravis (MG). The announcement follows an end-of-Phase 2 meeting between Kyverna and the U.S. Food and Drug Administration (FDA). According to the company, the FDA has…

Cartesian Therapeutics is gearing up for two clinical trials of its cell therapy Descartes-08: the first, a Phase 3 study, will enroll adults with myasthenia gravis (MG), while the second, a Phase 2 basket trial, will test the treatment candidate in children with juvenile MG and other…

Japan’s drug regulatory agency has authorized two new administration methods for Rystiggo (rozanolixizumab) — an approved treatment for generalized myasthenia gravis (gMG) — that people with the chronic autoimmune condition can use at home. These approvals, by the Pharmaceuticals and Medical Devices Agency, or PMDA, will allow gMG…

The recently approved prefilled syringe formulation of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) that offers the possibility of self-administration is now available in the U.S. for eligible adults with generalized myasthenia gravis (gMG) who have antibodies against acetylcholine receptors (AChRs). These ready-to-use syringes are intended to be…

Plasma exchange — a procedure that clears antibodies, such as those that cause myasthenia gravis (MG), from the blood — may be a better myasthenic crisis treatment when used in combination with a procedure used to remove white blood cells, a study found. The combined procedure, called lymphoplasmapheresis, achieved…

Enrollment is now complete for a Phase 2 clinical trial testing Dianthus Therapeutics‘ treatment candidate DNTH103 in people with generalized myasthenia gravis (gMG). According to the developer, the initial results from the global study, dubbed MAGIC (NCT06282159), are expected by early fall. MAGIC was launched early…

The U.S. Food and Drug Administration (FDA) has approved nipocalimab as a treatment for adults and adolescents, ages 12 and older, with generalized myasthenia gravis (gMG) who have antibodies against the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) proteins. The newly approved therapy will be sold by developer…

Vyvgart (efgartigimod alfa-fcab) is faster and more effective at reducing symptoms to a minimum than standard treatment with corticosteroids and/or immunosuppressants in adults with myasthenia gravis (MG), a real-world study showed. Data showed that Vyvgart was particularly effective at easing symptoms affecting muscles involved in breathing, speech, and…

Levels of antibodies against muscle-specific kinase (MuSK) are not reflective of disease severity in people with MuSK-positive myasthenia gravis (MG), according to a study. “Given our results, MuSK autoantibodies are not suitable as biomarkers for clinical severity or prognosis in MuSK-positive MG,” the researchers wrote. The study, “…

People with generalized myasthenia gravis (gMG) who were misdiagnosed at least once and who have certain disease symptoms are more likely to see an increase in disease severity, according to a recent study. Ocular symptoms and/or muscle aches after physical activity were significantly associated with a higher risk of…