A new treatment option for generalized myasthenia gravis (gMG) may be on the horizon, as Remegen’s telitacicept delivers encouraging Phase III results across key patient groups, according to GlobalData.

Remegen’s new drug telitacicept has shown positive results in a Phase III trial for people with generalised myasthenia gravis (gMG), a rare autoimmune disease that causes muscle weakness. The study included patients who tested positive for AChR or MuSK antibodies—two common forms of gMG. The data, shared at the 2025 American Academy of Neurology (AAN) meeting, shows that telitacicept may become a new option for patients, but it will face strong competition in an already busy treatment space, according to GlobalData.

Telitacicept works by targeting B cells, a type of immune cell involved in the disease. It is given once a week and showed improvements in daily activity levels and muscle strength scores just four weeks after starting treatment. These benefits continued for the full 24 weeks of the trial. The drug was also well-tolerated, with a similar number of side effects compared to the placebo group and fewer infection-related issues.

An expert from the Pharma Analyst team at GlobalData said the results are important because many approved treatments today are mainly for patients with AChR+ gMG. Telitacicept could help both AChR+ and MuSK+ patients, which may give it a wider reach. However, there are already six disease-modifying therapies (DMTs) approved in major markets like the US, the UK, Japan and Europe, including well-known drugs like complement inhibitors and FcRn inhibitors.

There are also several drugs in late-stage development, and many doctors already use the drug rituximab off-label to treat MuSK+ patients. Rituximab is known to work well and is also available as a low-cost biosimilar, making it tough for telitacicept to compete unless it clearly shows better results.

GlobalData suggests that to stand out, Remegen may need to run direct comparison studies with other treatments already on the market. Even though the trial results are promising, telitacicept’s future depends on how well Remegen can position it in this crowded and competitive treatment area.