VRDN: Lumvoa (veligrotug) Approved As Anticipated, Label Is Broad With Differentiated Edge On Efficacy

研报英文原文证据摘录

VRDN: Lumvoa (veligrotug) Approved As Anticipated, Label Is Broad With Differentiated Edge On Efficacy

EQUITY RESEARCH QUICK TAKE

RBC Capital Markets, LLC

Lisa Walter, Ph.D. (Analyst)

Luca Issi, Ph.D. (Analyst)

Shelby Hill, Ph.D. (Senior Associate)

Cassie Yuan, Ph.D. (Senior Associate)

June 28, 2026

Viridian Therapeutics, Inc.

Lumvoa (veligrotug) Approved As Anticipated, Label Is Broad With Differentiated Edge On

Efficacy

NASDAQ: VRDN | USD 17.90 | Outperform | Speculative Risk | Price Target USD 34.00

Sentiment: Positive

The News: VRDN announced on June 26 that the FDA granted approval to Lumvoa (veligrotug-vvze) for the treatment of thyroid

eye disease (TED) regardless of disease activity or duration. Lumvoa is VRDN’s first FDA-approved medicine and first commercial

product, and is the first approved treatment for TED with labeling that includes data for both active and chronic TED and is the

second IGF-1R inhibitor approved for TED after AMGN’s (covered by RBCCM Analyst Luca Issi) Tepezza (teprotumumab, approved

2020), which currently generates ~$2b in annualized revenue. There is no black box warning, no REMS, and no mandatory

monitoring (except for patients with hyperglycemia or preexisting diabetes, a known risk factor for the class). Both proptosis and

diplopia response are included in the clinical section of the label for both active and chronic disease (we note, Lumvoa is the first

approved TED product to demonstrate stat. sig. diplopia response & resolution in both populations), however change in clinical

activity score (CAS) and ORR are not included. VRDN plans to launch Lumvoa immediately and physicians can prescribe starting

now. The company has created ViridianCares, a comprehensive patient support program that provides dedicated patient access