Also known as: Vyvgart, VYVGART
FDA approved Viridian's Lumvoa (veligrotug-vvze) for thyroid eye disease on June 26, 2026; immediate U.S. launch followed. Q2 2026 cash stood at $982 million, and elegrobart BLA submission is on track for Q1 2027.
TG Therapeutics reported positive Phase 1 data for subcutaneous BRIUMVI in myasthenia gravis and started a Phase 2 trial; five-year ULTIMATE data in JAMA Neurology showed sustained MS efficacy.
The FDA expanded efgartigimod approval to all adult generalized myasthenia gravis serotypes. Phase 3 ADAPT SERON met its primary endpoint and showed no new safety signals.
Zai Lab's Q1 2026 revenue fell 6% to $99.6 million, missing expectations, while EPS beat at -$0.05. The company highlighted Zoci intracranial response data and expects three pivotal trials by year-end 2026.
argenx reported $1.3B in Q1 2026 global product net sales (63% YoY growth). The FDA PDUFA target date for seronegative gMG is May 10, 2026. Positive ADAPT OCULUS results support an oMG label expansion. Pipeline milestones include myositis readout in Q3 2026 and MMN readout in Q4 2026.
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.
Biotech investors are closely watching cystic fibrosis drug trials, rare-disease therapies and regulatory catalysts. Sionna Therapeutics is advancing a new CF drug class, while Praxis Precision Medicines targets essential tremor. FDA staffing challenges add uncertainty to approval timelines.
Global orphan drug sales are forecast to reach $409 billion by 2032, representing one-fifth of prescription drug sales, with Johnson & Johnson and Argenx leading the market amid regulatory uncertainty.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07217587 |
Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis |
RECRUITING | PHASE3 |
| NCT07025330 |
A Study of Efgartigimod in Patients With IgG4-Related Disease |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06831058 |
A Pilot Study of Efgartigimod for Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) |
RECRUITING | PHASE2 |
