Viridian stock jumps on data for lead drug (NASDAQ:VRDN)

Viridian Therapeutics (NASDAQ:VRDN) on Tuesday announced topline results from its THRIVE Phase 3 clinical trial designed to assess its lead candidate veligrotug (VRDN-001) in patients with active thyroid eye disease (TED).

Based on 15-week data, the company said that the 113-patient trial met the primary endpoint after five infusions, indicating a statistically significant and clinically meaningful 70% proptosis responder rate (PRR), compared to 5% in the placebo arm.

Viridian (VRDN) shares climbed ~11% in the premarket after the readout. THRIVE also met secondary endpoints with statistical significance and clinical meaningfulness for patient outcomes, such as the complete resolution of diplopia.

As for safety, most adverse events ((AEs)) were mild, though 4% of patients in the veligrotug arm discontinued the trial. The company added that there were no treatment-related serious adverse events.

Viridian’s (VRDN) second Phase 3 trial for candidate THRIVE-2 in patients with chronic TED is currently underway, with topline data from that study expected by the end of this year.

The company remains on track to submit a biologics license application in H2 2025, to seek FDA approval for veligrotug.