Lumvoa (veligrotug-vvze) / Sanofi, Viridian Therap, Zenas BioPharma, AbbVie, ZAI Lab, Kissei - LARVOL DELTA

Efficacy and Safety of IGF-1 Receptor Inhibitors for Thyroid Eye Disease: Systematic Review and Meta-analysis of Randomized Controlled Trials. (PubMed, Drugs) - "IGF-1R inhibitors outperformed placebo across multiple efficacy outcomes. These findings confirm their robust efficacy in TED, particularly in active disease. Given the increased adverse event risk, IGF-1R inhibitors warrant vigilant monitoring, including baseline and on-treatment glycemic and audiometric assessments, to ensure optimal safety."

Journal • Retrospective data • Review • Ophthalmology • Thyroid Eye Disease • IGF1

An Open-Label Trial of Veligrotug in Participants With Thyroid Eye Disease Who Previously Responded to Teprotumumab (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Viridian Therapeutics, Inc.

New P4 trial • Ophthalmology • Thyroid Eye Disease

Cost-effectiveness and value implications of veligrotug versus teprotumumab for moderate-to-severe thyroid eye disease in the United States. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "It would become cost-effective only at a course price roughly 3.4% below its current WAC, identifying a concrete price target for value-aligned coverage. Non-price advantages, notably its shorter infusion course, may nonetheless influence real-world value."

HEOR • Journal • Immunology • Ophthalmology • Thyroid Eye Disease

Recent advances in the medical management of thyroid eye disease. (PubMed, Curr Opin Endocrinol Diabetes Obes) - "The development of novel targeted medications with expanding therapeutic options may facilitate personalized management of TED in the future."

Journal • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Otorhinolaryngology • Thyroid Eye Disease • IL6

THRIVE and THRIVE-2 Phase 3 Studies of Veligrotug: Treatment Effect Across Subgroups of Thyroid Eye Disease Duration, Severity, and Clinical Activity (ATA 2026) - No abstract available

Clinical • P3 data • Ophthalmology • Thyroid Eye Disease

Patient Level Characterization of Proptosis Response in the THRIVE-2 Phase 3 Trial of Veligrotug for Chronic Thyroid Eye Disease (TED) (ATA 2026) - No abstract available

Clinical • P3 data • Ophthalmology • Thyroid Eye Disease

Quality of Life Improvements and Relationship to Proptosis and Diplopia Response in the THRIVE Phase 3 Trial of Veligrotug in Active Thyroid Eye Disease (TED) (ATA 2026) - No abstract available

HEOR • P3 data • Ophthalmology • Thyroid Eye Disease

Characterization of Proptosis Response in the THRIVE Phase 3 Trial of Veligrotug for Active Thyroid Eye Disease (TED) (ETA 2026) - P3 | "A 12-week 5-infusion treatment regimen of 10 mg/kg veligrotug was generally well tolerated and led to significant improvement in proptosis among patients with active TED. In the veligrotug group, no increase in proptosis was observed, and among the 71% responders, a substantial proptosis reduction was observed at Week 15. Assessing proptosis response at the individual-patient level may provide deeper insight into veligrotugs effect and inform treatment expectations."

P3 data • Ophthalmology • Thyroid Eye Disease

THRIVE-2 Phase 3 Trial of Veligrotug in Chronic Thyroid Eye Disease (TED): Efficacy, Safety, and Quality of Life at Week 15 (ETA 2026) - P3 | "In patients with chronic TED, a 12-week, 5-infusion regimen of 10 mg/kg veligrotug was generally well tolerated and led to statistically significant improvements in TED signs/symptoms. Most veligrotug-treated patients improved in at least one key domain of proptosis response, diplopia resolution, or disease inactivation, which translated into clinically meaningful improvements in QoL."

Clinical • HEOR • P3 data • Ophthalmology • Thyroid Eye Disease

Veligrotug: Expanding Treatment Options for Thyroid Eye Disease. (PubMed, Ophthalmology) - No abstract available

Journal • Ophthalmology • Thyroid Eye Disease

Raymond Douglas, MD, PhD…is the first in the United States to administer LUMVOA (veligrotug-vvze), an infusion therapy for thyroid eye disease (TED), post its FDA-approval (PRNewswire)

Clinical • Thyroid Eye Disease

Viridian Therapeutics Announces U.S. FDA Approval and Launch of Lumvoa (veligrotug-vvze) for the Treatment of Thyroid Eye Disease (Businesswire) - "Viridian plans to launch Lumvoa immediately, and physicians can prescribe Lumvoa tomorrow....Lumvoa was approved by the FDA under Priority Review and supported by the THRIVE (active TED) and THRIVE-2 (chronic TED) pivotal phase 3 clinical trials....Across both clinical trials, patients received a 12-week course of Lumvoa designed to reduce the burden of treatment. Lumvoa demonstrated a rapid onset of clinical benefit, with reductions in proptosis observed as early as three weeks."

FDA approval • Launch US • Thyroid Eye Disease

Characterization of Proptosis Response in the THRIVE Phase 3 Trial of Veligrotug for Active Thyroid Eye Disease (TED) (ENDO 2026) - P3 | "A 12-week 5-infusion treatment regimen of 10 mg/kg veligrotug was generally well tolerated and led to significant improvement in proptosis among patients with active TED. No increase in proptosis was observed in veligrotug-treated patients, and among the 71% who were responders, a substantial proptosis reduction (mean 3.7 mm) was observed at Week 15. Assessing proptosis reduction at the individual-patient level may better inform treatment expectations."

P3 data • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • IGF1

THRIVE: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Study of Veligrotug for Active Thyroid Eye Disease. (PubMed, Ophthalmology) - "A 5-infusion course of veligrotug administered over 12 weeks was generally well tolerated and led to rapid and significant improvements in diplopia, proptosis, and disease activity, with a durable response through week 52. Veligrotug may become a promising new treatment option for active TED."

Journal • P3 data • Immunology • Ophthalmology • Thyroid Eye Disease

Earlier this week, Viridian linked up with Chinese pharma manufacturing juggernaut WuXi Biologics on a long-term supply pact for the drug, according to a May 26 filing with the Securities and Exchange Commission (SEC) (Fierce Pharma) - "The deal calls on WuXi Bio to supply drug substance and drug product for commercial use for an initial period of 5 years, after which the agreement could be extended. Notably, Viridian said WuXi Bio will be a 'non-exclusive supplier' and that it could tap other CDMOs to assist with veligrotug supply. In addition, the agreement could come to an early end if 'there is a change in applicable laws that materially and adversely impacts WuXi’s Biologics ability to perform services,' according to the filing."

Licensing / partnership • Thyroid Eye Disease

COST-EFFECTIVENESS OF VELIGROTUG VERSUS TEPROTUMUMAB FOR MODERATE-TO-SEVERE THYROID EYE DISEASE IN THE UNITED STATES (ISPOR 2026) - "Under plausible pricing assumptions, veligrotug may represent a cost-effective and potentially cost-saving alternative to teprotumumab for moderate-to-severe TED. Final pricing and real-world effectiveness data will be critical to confirming its economic value following regulatory approval."

Cost effectiveness • HEOR • Ophthalmology • Thyroid Eye Disease

PDUFA target action date of June 30, 2026 for veligrotug in thyroid eye disease (TED); organization is launch-ready (Businesswire)

PDUFA • Thyroid Eye Disease

THRIVE Phase 3 trial of veligrotug in thyroid eye disease completed enrollment…topline data expected in the second half of 2026 (Businesswire)

P3 data: top line • Thyroid Eye Disease

Characterization of Proptosis Response Among Responders Treated with Veligrotug in the THRIVE Phase 3 Trial for Active Thyroid Eye Disease (TED) (AACE 2026) - P3 | "Among veligrotug responders, proptosis Discussion/Conclusion A 12-week 5-infusion treatment regimen of 10 mg/kg veligrotug was generally well tolerated and led to rapid and robust improvements in proptosis responders in the THRIVE trial by week 15. No increase in proptosis was observed in veligrotug-treated patients, and among the 71% who were responders, a substantial proptosis reduction (mean 3.7 mm) was observed at week 15."

P3 data • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease

Marketing Authorization Application (MAA) for veligrotug for TED submitted to the European Medicines Agency (EMA) in January 2026 (Businesswire)

EMA filing • Thyroid Eye Disease

STRIVE: A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=231 | Completed | Sponsor: Viridian Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Thyroid Eye Disease

Therapeutic Advances in Graves' Orbitopathy: From Corticosteroids to Targeted Immunotherapy - Insights from the TOGO and THRIVE Trials. (PubMed, Ann Endocrinol (Paris)) - No abstract available

Journal • Thyroid Eye Disease

Viridian Therapeutics Announces BLA Acceptance and Priority Review for Veligrotug for the Treatment of Thyroid Eye Disease (Businesswire) - "The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026... In THRIVE and THRIVE‑2, conducted in active and chronic TED patients, respectively, veligrotug met the primary and all secondary endpoints of each study as well as demonstrated a rapid onset of clinical benefit. For the first time in a phase 3 clinical trial in chronic TED, veligrotug demonstrated statistically significant diplopia response and diplopia resolution...Preparations are well underway for veligrotug’s anticipated commercial launch. The company also plans to submit a Marketing Authorization Application to the European Medicines Agency in the first quarter of 2026."

EMA filing • FDA filing • PDUFA • Priority review • Thyroid Eye Disease

Preclinical pharmacology, pharmacokinetics, and pharmacodynamics of veligrotug, a full antagonist antibody to the IGF-1 receptor in development for thyroid eye disease. (PubMed, MAbs) - "Binding epitope and antagonist properties were compared to teprotumumab (Tepezza®), a marketed anti-IGF-1R antibody. Veligrotug's pharmacologic, pharmacokinetic, and pharmacodynamic characteristics make it a good candidate for clinical development. Indeed, efficacy data at week 15 from two Phase 3 pivotal studies of veligrotug, THRIVE and THRIVE-2, showed statistically significant improvements in TED symptoms based on primary and secondary outcomes."

Journal • PK/PD data • Preclinical • Endocrine Disorders • Grave’s Disease • Inflammation • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • IGF1 • IR

Viridian Therapeutics Announces Successful October Submission of Biologics License Application (BLA) to U.S. FDA for Veligrotug in Thyroid Eye Disease (Businesswire) - "The BLA submission is supported by data from two pivotal phase 3 clinical trials, THRIVE and THRIVE-2, evaluating the efficacy and safety of veligrotug in patients with active and chronic TED, respectively....Viridian’s BLA includes a request for Priority Review, which if granted, could accelerate FDA's review timing for a potential mid-2026 veligrotug commercial launch, if approved."

FDA filing • Launch US • Thyroid Eye Disease