- Viridian stated that the REVEAL-1 trial showed strong results, meeting its main goal and a key secondary goal at week 24 as measured by eye bulging.
- The company stated that Elegrobart reduced eye bulging by about 54% in the four-week regimen and by 63% in the eight-week regimen, compared with roughly 18% on placebo.
- Viridian stated that topline results from REVEAL-2, the second Phase 3 trial evaluating Elegrobart in patients with chronic thyroid eye disease, are expected in the second quarter of 2026.
Viridian Therapeutics Inc. (VRDN) shares tanked more than 41% in Monday’s pre-market trade after the company announced results from its Phase 3 REVEAL‑1 Clinical Trial in Active Thyroid Eye Disease.
Viridian stated that the REVEAL-1 trial of Elegrobart met its primary endpoint of proptosis responder rate (PRR) with a highly statistically significant treatment effect in the four-week dosing regimen.
However, the company stated that while Elegrobart was generally well tolerated in the four and eight-week dosing regimens, the phase 3 trial showed low rates of hearing impairment.
Retail sentiment on Stocktwits around Viridian Therapeutics trended in the ‘bullish’ territory with message volumes at ‘high’ levels at the time of writing.
What Did The Trial Reveal?
Viridian stated that the REVEAL-1 trial showed strong results, meeting its main goal and a key secondary goal at week 24 as measured by eye bulging. The study also tested a different dosing schedule (every 8 weeks) versus placebo and examined other important outcomes.
The company stated that Elegrobart reduced eye bulging by about 54% in the four-week regimen and by 63% in the eight-week regimen, compared with roughly 18% on placebo.
However, Elegrobart showed only a slight improvement over placebo in the Clinical Activity Score (CAS), a measure of inflammation and disease activity.
Viridian’s results showed that the CAS reduction to 0 or 1 was 57% in the four-week regimen and 69% in the eight-week regimen, compared with 50% in the placebo group.
The company said that all complaints of adverse events in both regimens were reports of tinnitus, none of which were associated with hearing reduction.
Viridian Says Elegrobart On Track For BLA Submission In 2027
The company stated that topline results from REVEAL-2, the second Phase 3 trial evaluating Elegrobart in patients with chronic thyroid eye disease, are expected in the second quarter (Q2) of 2026.
Following this, Viridian plans to submit a Biologics License Application (BLA) to the U.S. FDA in Q1 2027. A BLA is a formal request submitted to the U.S. Food and Drug Administration (FDA) asking for approval to sell a biologic drug.
VRDN stock is down 12% year-to-date, but up 87% over the past 12 months. The SPDR S&P Biotech ETF (XBI) is up 40% over the past 12 months, while the iShares Russell 2000 ETF (IWM) is up 19%.
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