>
pdufa.bio

Veligrotug (VRDN-001)

Updated ยทnext FDA decision on the calendar

Veligrotug (VRDN-001) is a Viridian Therapeutics Inc. program in Thyroid Eye Disease (TED). The FDA approved it on Jun 26, 2026. 1 FDA decision on record below. Every date links its source.

VRDN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Veligrotug (VRDN-001) is marketed as Lumvoa (veligrotug-vvze); the events below include those tracked under the brand name. Indication under review: Thyroid Eye Disease (TED). Sponsor: Viridian Therapeutics Inc. (VRDN). Review status: Viridian states a PDUFA target action date of June 30, 2026 for veligrotug in thyroid eye disease, with the company describing itself as launch-ready. Market-cap tier at the time we tracked it: Small. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Jun 26, 2026 ✓ ApprovedVRDNPDUFA · Jun 30, 2026VRDN

Questions

When is Veligrotug (VRDN-001)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Veligrotug (VRDN-001); 1 FDA decision is on record below.

What happened at Veligrotug (VRDN-001)'s most recent FDA decision?

On Jun 26, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is Veligrotug (VRDN-001) used for?

In our records Veligrotug (VRDN-001) is under review or in development for Thyroid Eye Disease (TED).

Who makes Veligrotug (VRDN-001)?

Viridian Therapeutics Inc. (VRDN).

Has Veligrotug (VRDN-001) been approved by the FDA?

Yes. The FDA approved an application for Veligrotug (VRDN-001) on Jun 26, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.