Myasthenia Gravis

Kyverna Therapeutics will present interim Phase 2 KYSA-6 trial results for KYV-101 in myasthenia gravis at the AANEM meeting in October 2025. Data from six patients with up to 9 months follow-up will be shared. KYV-101, a CD19 CAR T-cell therapy, aims for durable remission after a single dose. The study has been upgraded to a registrational Phase 2/3 trial, with Phase 3 initiation planned by year-end 2025. The presentation by Dr. Srikanth Muppidi will be on October 29th.

Dianthus Therapeutics (DNTH) will report topline results from its Phase 2 MaGic trial of claseprubart (DNTH103) in generalized Myasthenia Gravis (gMG) on September 8, 2025, at 8:00 a.m. EDT. The clinical-stage biotech company, focused on antibody complement therapeutics for autoimmune diseases, will host a conference call and webcast with a Q&A session. Investors can access the webcast via the company’s investor relations website, with a replay available afterward. Claseprubart targets the classical complement pathway, potentially offering a targeted gMG treatment.

Argenx’s VYVGART® demonstrated statistically significant improvements in AChR-Ab seronegative generalized myasthenia gravis (gMG) patients in the ADAPT SERON phase 3 study (p=0.0068). This is the first global Phase 3 study showing benefits across MuSK+, LRP4+, and triple seronegative subtypes. Argenx plans to submit an sBLA to the FDA by the end of 2025 to expand VYVGART’s label. The drug maintained its consistent safety profile. The results position VYVGART as a potential foundational therapy for a broader gMG population.