Viridian Therapeutics confirmed that the U.S. Food and Drug Administration accepted its Biologics License Application for Veligrotug, the company’s lead therapy for thyroid eye disease, and granted the application Priority Review status. The acceptance was announced on December 22, 2025, with a PDUFA target action date of June 30, 2026, shortening the review timeline to six months from the standard ten months.
The Priority Review designation signals that the FDA believes Veligrotug offers a meaningful improvement in safety or effectiveness for patients with TED. The decision is anchored in robust Phase III data that showed a 68% responder rate for proptosis reduction and a 55% resolution rate for diplopia after a five‑infusion course over 12 weeks, compared with the 45% and 30% rates seen with the current standard of care. The shorter, five‑infusion regimen also reduces patient burden and could improve adherence.
Veligrotug’s entry would address a market that is currently dominated by Amgen’s Tepezza, which has captured less than 10% of the roughly 100,000 TED patients in the United States. The global TED market was valued at $2.3 billion in 2023 and is projected to grow, creating a sizable opportunity for a differentiated therapy that can offer a more convenient dosing schedule.
Management emphasized the significance of the milestone, with President and CEO Steve Mahoney stating, “The FDA’s recognition of Veligrotug’s potential to improve safety and effectiveness for TED patients is a major step forward for Viridian and our patients.” He added that the company is preparing for a commercial launch in the U.S. and plans to submit a marketing authorization application to the European Medicines Agency in the first quarter of 2026.
Analysts have responded positively to the FDA acceptance, with several firms upgrading coverage and raising price targets. The consensus rating among 15 analysts is “Strong Buy,” and the average price target is $43.08, reflecting confidence in Veligrotug’s commercial potential and the company’s execution track record.
Viridian is also advancing VRDN‑003, a subcutaneous therapy for TED, and other pipeline candidates for autoimmune diseases, positioning the company to diversify its revenue streams and mitigate reliance on a single product.
The FDA acceptance and Priority Review accelerate Viridian’s path to market, reduce the time to commercial launch, and strengthen its competitive stance against Tepezza, potentially capturing a significant share of the growing TED market.
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