← Back to Calendar

veligrotug

Viridian Therapeutics · $VRDN

Priority Review Breakthrough Therapy BLA

PDUFA Date

June 30, 2026

Time Remaining

98 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical BLA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

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.

← Back to Full Calendar