Shares of Viridian Therapeutics (NASDAQ:VRDN) surged 40% on Tuesday after the company disclosed topline findings from its Phase 3 REVEAL-2 trial evaluating elegrobart for chronic thyroid eye disease.
The REVEAL-2 study achieved its primary endpoint, with both elegrobart dosing schedules generating substantially higher proptosis responder rates at week 24 versus placebo. Patients receiving elegrobart every four weeks (Q4W) had a 50% proptosis responder rate at week 24, while the every-eight-week (Q8W) group reached a 54% responder rate. Placebo patients had a 15% responder rate. Both active-arm results were reported as highly statistically significant with p < 0.0001.
In addition to the proptosis outcome, the Q4W regimen produced a 61% diplopia responder rate at week 24 compared with 38% in the placebo arm, a difference that was statistically significant (p = 0.0118). Mean changes from baseline in proptosis measured -1.9 mm for the Q4W group and -2.1 mm for the Q8W group, versus -0.5 mm for placebo.
The randomized trial enrolled 204 patients assigned in a 1:1:1 ratio: 70 patients received elegrobart Q4W, 68 received elegrobart Q8W, and 66 received placebo. According to the company, elegrobart was generally well tolerated across both dose groups and demonstrated a safety profile consistent with results from the earlier REVEAL-1 trial. The company reported low rates of hearing impairment in the study population.
Elegrobart is described by Viridian as a subcutaneously administered, half-life-extended monoclonal antibody that targets the insulin-like growth factor-1 receptor. The company intends to commercialize elegrobart as an at-home autoinjector.
REVEAL-2 represents the second pivotal Phase 3 success for elegrobart, following positive data from REVEAL-1 in active thyroid eye disease. Viridian said it remains on schedule to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration in the first quarter of 2027.
Beyond elegrobart, Viridian has another program in active regulatory review. The company noted that veligrotug is currently under Priority Review at the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026.
On the corporate finances front, Viridian reported cash, cash equivalents, and marketable securities totaling $762.2 million as of March 31, 2026.
Market reaction and implications
The stock move reflects investor response to the topline efficacy and tolerability signals reported from REVEAL-2. The company’s timeline for a potential BLA submission and the concurrent regulatory review of veligrotug are material milestones that market participants may focus on going forward.
What the data show
- Proptosis responder rates at week 24: 50% (elegrobart Q4W), 54% (elegrobart Q8W), 15% (placebo); both active arms p < 0.0001.
- Diplopia responder rate at week 24: 61% (Q4W) vs 38% (placebo); p = 0.0118.
- Mean change in proptosis: -1.9 mm (Q4W), -2.1 mm (Q8W), -0.5 mm (placebo).
- Trial enrollment: 204 patients randomized 1:1:1 (Q4W n = 70; Q8W n = 68; placebo n = 66).
Outlook
With two successful pivotal trials for elegrobart and an ongoing regulatory review for a second program, Viridian has articulated both near-term regulatory milestones and a plan to offer elegrobart as an at-home autoinjector if approved. The company’s cash and marketable securities position as of March 31, 2026 stands at $762.2 million.
This report summarizes the topline REVEAL-2 outcomes and the company updates provided by Viridian. Additional details and full study data were not included in the topline announcement.