Viridian Therapeutics’ stock is up by 35% after it announced its Phase III chronic thyroid eye disease (TED) study met its primary endpoint.
The REVEAL‑2 trial (NCT06625398) investigated two doses of subcutaneous elegrobart in patients with TED. The study enrolled 204 patients, randomised 1:1:1 to elegrobart Q4W, elegrobart Q8W, or placebo.
The study met its primary endpoint of proptosis responder rate (exophthalmometry) and overall responder rate (ORR). The US Food and Drug Administration (FDA) requested the former while the European Medicines Agency (EMA) requested the latter.
Propotsis responder rate reached 50% in the four-weekly dosing cohort and 54% in the eight-weekly dosing cohort, compared to 15% in the placebo cohort.
ORR was achieved by 47% of patients in the four-weekly dosing cohort and 54% in the eight-weekly dosing group, compared with 15% in the placebo arm.
In addition, REVEAL-2 met all its proptosis key secondary endpoints in the Q4W and Q8W treatment arms with high statistical significance, and the Q4W treatment arm showed a statistically significant diplopia responder rate at week 24. Efficacy was generally consistent regardless of baseline Clinical Activity Score (CAS).
After the data was released, Viridian Therapeutics’ stock opened 35.6% up, at $19.07 on 5 May, compared to a $14.06 close on 4 May. This also comes on the same day the company announced its Q1 earnings.
Dr John Mandeville, an oculoplastic surgeon at Ophthalmic Consultants of Boston and who is also a clinical associate at the Massachusetts General Hospital, said: “Chronic TED remains a challenging condition. Many patients have been living with this disease for years or decades and would benefit from an effective and convenient treatment option. These REVEAL 2 results demonstrate the potential for elegrobart to provide meaningful improvement in the signs and symptoms of TED in as few as three doses. What’s more, a simple autoinjector that patients can use at home could be an attractive option for many patients living with chronic disease.”
Elegrobart was generally well tolerated in REVEAL‑2 with a safety profile consisting of adverse events (AEs) generally expected from the anti-IGF-1R class.
This readout marks the second successful pivotal Phase III clinical trial for elegrobart following positive results from REVEAL‑1 (NCT06625411) in active TED. Despite REVEAL-1 meeting its endpoint in March 2026, the company’s stock sank nearly 40% on the company update. It was believed this drop could have been due to whether elegrobart would meet current marketed therapies, as well as the PRR being lower than expected.
As a result, Viridian remains on track to submit a Biologics License Application (BLA) to the FDA for elegrobart in Q1 2027. If approved, Viridian said that elegrobart would offer a convenient, at‑home treatment in as few as three doses for both active and chronic patients.
Viridian is also in the process of filing another therapy for TED, veligrotug, which is under priority review at the agency with a Prescription Drug User Fee Act (PDUFA) target action date of 30 June 2026. The company’s stock jumped in September 2024 after it announced that the trial met all of its endpoints in TED.
While Viridian is showing promise with two new therapies, the company will face competition from Amgen’s Tepezza (teprotumumab-trbw). Tepezza is the first and only FDA-approved, targeted IV treatment for TED. The drug was approved in 2020 and brought in $1.9bn in global sales in 2025.
