Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06193889 |
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis |
RECRUITING | PHASE2/PHASE3 |
