Viridian Therapeutics Inc. (VRDN): Lumvoa Approved Slightly Ahead of PDUFA Date w/ Few Surprises

研报英文原文证据摘录

Viridian Therapeutics Inc. (VRDN): Lumvoa Approved Slightly Ahead of PDUFA Date w/ Few Surprises

Equity Research

29 June 2026 | 3:05AM EDT

Viridian Therapeutics Inc. (VRDN): Lumvoa Approved Slightly Ahead of

PDUFA Date w/ Few Surprises

On Friday 6/26 after market close, VRDN announced FDA’s approval and commercial Richard Law, Ph.D.

+1(212)357-6054 | richard.law@gs.com

launch of Lumvoa (veligrotug-vvze) for the treatment of Thyroid Eye Disease (TED). Goldman Sachs & Co. LLC

Lumvoa became the first approved TED treatment with a label that includes data for Jane Wu, Ph.D.

both active and chronic TED which will allow VRDN to promote directly to chronic +1(212)357-0180Goldman Sachs & Co.| jane.wu@gs.comLLC

patients. Additionally, Lumvoa’s label contains data that shows numerically higher Tolani Uthman

diplopia responses, faster onset of action, fewer infusions, and shorter duration of +1(212)357-6412tolani.uthman@gs.com|

administration. Surprisingly, Lumvoa’s label includes monitoring patients for signs Goldman Sachs & Co. LLC

and symptoms of IBD in the warning/precaution despite the company has not

previously mentioned IBD in THRIVE’s presentations. We believe this suggests the

FDA considers IBD as a class effect for IGF-1R inhibitors since it was observed it

Tepezza’s clinical trials and postapproval use but not directly mentioned in Lumvoa’s

trials. Overall, Lumvoa’s label was mostly expected. We continue to believe its

advantages could compete well with Tepezza and take meaningful shares while

broaden the use in chronic TED which could further be enhanced when the subcu

elegrobart launches. Although VRDN has not disclosed Lumvoa’s list price, it

reiterated that parity pricing with Tepezza’s total course of treatment will support

parity coverage.