# LUMVOA (veligrotug-vvze) PDUFA Event: Thyroid eye disease

Canonical URL: https://biopharmsignal.com/pdufa-calendar/VRDN/lumvoa-veligrotug-thyroid-eye-disease

Ticker: VRDN

Company: Viridian Therapeutics

Event date: 2026-06-30

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-06-26

Application type: BLA

FDA approved LUMVOA. FDA approved veligrotug for thyroid eye disease with labeling supported by pivotal evidence in both active and chronic disease.

## Event Timeline

### June 26, 2026 — FDA approved LUMVOA

FDA approved veligrotug for thyroid eye disease with labeling supported by pivotal evidence in both active and chronic disease.

[Viridian — LUMVOA FDA approval](https://www.viridiantherapeutics.com/press-release/viridian-therapeutics-announces-u-s-fda-approval-and-launch-of-lumvoa-veligrotug-vvze-for-the-treatment-of-thyroid-eye-disease/)

### December 22, 2025 — FDA accepted the BLA with Priority Review

FDA accepted the veligrotug BLA and assigned a June 30, 2026 PDUFA target action date.

[Viridian — Veligrotug BLA acceptance](https://www.viridiantherapeutics.com/press-release/viridian-therapeutics-announces-bla-acceptance-and-priority-review-for-veligrotug-for-the-treatment-of-thyroid-eye-disease/)

### December 16, 2024 — THRIVE-2 reported positive Phase 3 results

Veligrotug met all primary and secondary endpoints in chronic thyroid eye disease, including statistically significant proptosis and diplopia responses.

[Viridian — Positive THRIVE-2 topline results](https://investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Veligrotug-Phase-3-THRIVE-2-Clinical-Trial-in-Patients-with-Chronic-Thyroid-Eye-Disease/default.aspx)

### September 10, 2024 — THRIVE reported positive Phase 3 results

The active-disease pivotal trial met its primary and all secondary endpoints, with a 70% proptosis response rate at Week 15.

[Viridian — Positive THRIVE topline results](https://www.viridiantherapeutics.com/press-release/viridian-therapeutics-announces-positive-topline-results-from-veligrotug-vrdn-001-phase-3-thrive-clinical-trial-in-patients-with-active-thyroid-eye-disease/)

### December 3, 2021 — Veligrotug clinical study started

The clinical program began evaluating the anti-IGF-1R antibody in healthy volunteers and patients with thyroid eye disease and later expanded into the pivotal THRIVE program.

[ClinicalTrials.gov — Veligrotug study record (NCT05176639)](https://clinicaltrials.gov/study/NCT05176639)

## Regulatory Designations

- Priority Review FDA: [Viridian — BLA acceptance and Priority Review](https://www.viridiantherapeutics.com/press-release/viridian-therapeutics-announces-bla-acceptance-and-priority-review-for-veligrotug-for-the-treatment-of-thyroid-eye-disease/)

- Breakthrough Therapy FDA: [Viridian — BLA acceptance and Breakthrough Therapy designation](https://www.viridiantherapeutics.com/press-release/viridian-therapeutics-announces-bla-acceptance-and-priority-review-for-veligrotug-for-the-treatment-of-thyroid-eye-disease/)

## Related Pages

- VRDN PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/VRDN.md

- VRDN company profile: https://biopharmsignal.com/company/VRDN.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2022-04-06 — Viridian Therapeutics to Participate in The 21st Annual Needham Virtual Healthcare Conference on April 14: https://biopharmsignal.com/news/VRDN/viridian-therapeutics-to-participate-in-the-21st-annual-needham-virtual-healthca-108c221d.md

- 2022-04-04 — Viridian Therapeutics Secures Flexible Credit Facility for Up to $75 Million From Hercules Capital: https://biopharmsignal.com/news/VRDN/viridian-therapeutics-secures-flexible-credit-facility-for-up-to-75-million-from-747e1dc0.md

- 2022-03-21 — Viridian Therapeutics Doses First Subject in First-in-Human Clinical Trial Evaluating VRDN-002, a Next Generation IGF-1R Antibody for the Treatment of Thyroid Eye Disease: https://biopharmsignal.com/news/VRDN/viridian-therapeutics-doses-first-subject-in-first-in-human-clinical-trial-evalu-f60b07d3.md

- 2022-03-14 — Viridian Therapeutics to Participate in 32nd Annual Oppenheimer Healthcare Conference on March 15: https://biopharmsignal.com/news/VRDN/viridian-therapeutics-to-participate-in-32nd-annual-oppenheimer-healthcare-confe-9db95b4d.md

- 2022-03-10 — Viridian Therapeutics Reports Fourth Quarter And Full Year 2021 Financial Results And Provides Corporate Updates: https://biopharmsignal.com/news/VRDN/viridian-therapeutics-reports-fourth-quarter-and-full-year-2021-financial-result-50ad5708.md