Viridian Therapeutics, Inc. (NASDAQ:VRDN) shares are up during Tuesday’s premarket session as the company announced positive topline results from its REVEAL-2 Phase 3 clinical trial for elegrobart, a treatment for chronic thyroid eye disease (TED).
The trial met its primary endpoint with statistically significant treatment effects, likely contributing to the stock’s upward momentum.
VRDN Stock Jumps On Positive REVEAL-2 Phase 3 Results
The REVEAL-2 trial demonstrated that elegrobart achieved proptosis (bulging eyes) responder rates of 50% and 54% for its Q4W and Q8W dosing regimens, respectively, compared with 15% in the placebo group.
Elegrobart Q4W achieved a statistically significant 61% diplopia (double vision) responder rate at week 24, versus 38% placebo.
Additionally, the drug was well tolerated, with a safety profile consistent with prior studies, and the company is on track for a BLA submission in Q1 2027.
If approved, elegrobart has the potential to offer a convenient, at‑home treatment in as few as three doses for both active and chronic patients.
Regulatory Momentum For Veligrotug Adds Near-Term Catalyst
Viridian is preparing for the planned U.S. launch of veligrotug, its lead therapy for TED.
The clinical-stage biopharmaceutical company expects its commercial and medical affairs infrastructure for veligrotug to also support a potential launch of elegrobart, with minimal additional investment.
Veligrotug has received Breakthrough Therapy Designation from the FDA, and its BLA is under Priority Review, with a PDUFA target action date of June 30.
VRDN Stock Price Activity: Viridian Therapeutics shares were up 15.00% at $16.17 during premarket trading on Tuesday, according to Benzinga Pro data.
Image via Shutterstock/ Rulo Jmp
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