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.
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.
Viridian Therapeutics reported positive Phase 3 results for elegrobart in thyroid eye disease, showing significant proptosis reduction and diplopia resolution. The company plans a BLA submission in Q1 2027 and has another IGF-1R inhibitor, veligrotug, under FDA Priority Review with a June 2026 decision date.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07762105 |
Study of Atorvastatin and Its Effects in Clinical and Radiological Aspects in Patients With Moderate-to-Severe Thyroid Eye Disease |
NOT_YET_RECRUITING | PHASE1 |
| NCT07720648 |
A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Inactive Thyroid Eye Disease |
NOT_YET_RECRUITING | PHASE3 |
| NCT07720635 |
A Phase III Study of KHN939 in Chinese Patients With Moderate-to-Severe Active Thyroid Eye Disease |
NOT_YET_RECRUITING | PHASE3 |
| NCT07623837 |
Clinical Validation of AI-Based Quantitative Eye Movement Analysis From Smartphone 9-Gaze Videos (Glandy EOM) |
NOT_YET_RECRUITING | |
| NCT07622368 |
A Study of IBI3031 in Participants With Thyroid Eye Disease |
RECRUITING | PHASE1 |
| NCT07438405 |
An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease |
RECRUITING | PHASE2 |
| NCT07265258 |
A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease |
RECRUITING | PHASE4 |
| NCT07155668 |
A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) |
COMPLETED | PHASE3 |
| NCT06625411 |
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06625398 |
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED) |
ACTIVE_NOT_RECRUITING | PHASE3 |
