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veligrotug

Viridian Therapeutics · $VRDN
Priority Review Breakthrough Therapy BLA
PDUFA Date
June 30, 2026
Date Status
20d ago (past)
Review Type
Priority (6 mo)
88%
Baseline PoA
BLA priority review approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

FDA Decision

✅
✓ FDA Approved
Decision issued: June 26, 2026
FDA Approved on 2026-06-26 (BLA761530). Source: FDA Drugs@FDA database.
Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761530

Live Company Data NCM

Updated just now · Data: FMP
Current Price
$18.03 +5.75%
+$0.98 today
Day: $17.54 – $18.24
Market Cap
N/A
Shares out: 110.43M
Float: 97.76M
52-Week Range
$13.18
$34.29
Current price is at 23% of 52-week range
Avg Volume
2.54M
Beta
0.90
vs. S&P 500
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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Indication

Thyroid eye disease (TED) — chronic, active

Key Notes

BLA accepted January 2026. PDUFA June 30, 2026. Positive Phase 3 THRIVE and THRIVE-2 trials — first Phase 3 trials to demonstrate diplopia response and resolution in chronic TED. Veligrotug is an anti-FcRn antibody administered every 3 weeks IV. Competitor to Tepezza (teprotumumab). Sub-$7B cap.
⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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