Jan. 14 at 7:10 PM
$VRDN The veligrotug BLA is supported by positive data from two of the largest phase 3 clinical trials conducted in TED to date, THRIVE and THRIVE‑2 in active and chronic TED, respectively.
Across active and chronic TED, following five infusions, veligrotug demonstrated rapid onset of treatment effect, clinically meaningful improvements in proptosis and diplopia, durable responses, and was generally well-tolerated.
Priority Review designation is granted to applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of treating a serious condition.
Commercial and field medical affairs preparation continues in anticipation of a potential mid‑2026 U.S. launch. Sales, market access, patient services, and medical affairs leadership teams have been in place, and engagement is ongoing with a target core prescriber base of ~2,000 physicians in the annualizing
$2 billion U.S. TED market.