VRDN

veligrotug

FDA PDUFA Target Action Date · Viridian Therapeutics, Inc.\DE

Tuesday, June 30, 2026

Approved

approved

Note: Approved 2026-06-26 as LUMVOA (ORIG BLA761530). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 4d from the PDUFA date.

Drug Information

Drug Name: veligrotug (CT.gov)
Indication: thyroid eye disease (TED)
Approved As: veligrotug

Filing Details

Company: Viridian Therapeutics, Inc.\DE
Stock Ticker: VRDN
SEC CIK: 0001590750
Source: SEC EDGAR (LLM-extracted from primary filing via full-text search) →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Track All FDA Decisions

View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.

View FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue