Viridian Therapeutics, Inc. (VRDN) on Tuesday announced positive topline results from the Phase 3 REVEAL-2 study of elegrobart in patients with chronic thyroid eye disease, sending its shares up more than 25% in pre-market trading.
The study met its primary endpoint for both the U.S. Food and Drug Administration and the European Medicines Agency with high statistical significance.
REVEAL-2 also achieved all key secondary endpoints related to proptosis in both the every-four-week (Q4W) and every-eight-week (Q8W) treatment arms, while the Q4W arm demonstrated a statistically significant improvement in diplopia responder rate at week 24. The efficacy profile was generally consistent across patients regardless of baseline Clinical Activity Score.
Elegrobart was generally well tolerated in the study.
The company said it expects to submit a Biologics License Application for elegrobart in the first quarter of 2027.
Viridian shares closed at $14.06 on Monday, up 4.77%.
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