Viridian Therapeutics, Inc. (VRDN) reported positive topline results from its Phase 3 REVEAL-1 trial, showing that Elegrobart met the primary endpoint with a highly statistically significant improvement in proptosis responder rate in patients with active thyroid eye disease. Despite the strong data, the stock traded sharply lower.
Thyroid eye disease (TED) is a painful and vision-threatening autoimmune condition that causes eye bulging, double vision, and inflammation. Current treatment options often require lengthy intravenous infusions, creating a need for more convenient therapies.
The REVEAL-1 study enrolled 132 patients and evaluated two dosing schedules for subcutaneous Elegrobart- every four weeks (Q4W) and every eight weeks (Q8W)- compared with placebo.
Elegrobart achieved a 54% proptosis reported rate in Q4W arm and 63% in Q8W arm, versus 18% placebo, meeting the primary endpoint with high statistical significance. The therapy also produced meaningful improvements in double vision, with 51% complete resolution of diplopia compared with 16% on placebo.
Viridian noted that the treatment regimen required as few as three subcutaneous doses, positioning Elegrobart as a potentially convenient alternative to the currently marketed therapy that requires eight intravenous infusions.
Elegrobart is a half-life-extended monoclonal antibody targeting IGF-1R, was generally well tolerated. Most side effects were mild and consistent with the anti-IGF-1R class. Rates of hearing-related adverse events were low, and all reported cases were tinnitus without associated hearing loss, consistent with the safety profile.
Viridian also highlighted progress across its broader TED portfolio. Topline results from REVEAL-2, the company's Phase 3 trial in chronic TED, remains on track for the second quarter of 2026, the company anticipates submitting a Biologics License Application (BLA) for Elegrobart in the first quarter of 2027.
In addition, Veligrotug, another IGF-1R inhibitor in Viridian's pipeline, is under Priority Review with a PDUFA target action date of June 30, 2026, and has received both Breakthrough Therapy Designation and Priority Review from the FDA. Viridian stated that its commercial infrastructure is nearing launch. Viridian ended 2025 with $874.7 million in cash, cash equivalents and marketable securities. The company said that its current cash position, together with potential near-term milestones from its royalty agreement and anticipated commercial revenues from Veligrotug and Elegrobart if approved, is expected to fund its business plans through profitability.
The company implemented a 1-for-6 reverse stock split on June 6, 2025.
VRDN is currently trading at $7.24, down 31.31%.
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