VRDN · Viridian Therapeutics, Inc.

Viridian Therapeutics reported highly statistically significant topline results from the REVEAL-1 phase 3 trial, the largest pivotal study in active thyroid eye disease (TED) to date, evaluating subcutaneous elegrobart, a half-life-extended anti-IGF-1R antibody. The trial enrolled 132 patients randomized 1:1:1 to elegrobart Q4W (n=44), Q8W (n=44), or placebo (n=44). It met the primary endpoint of Q4W proptosis responder rate at week 24 with 54% for Q4W (p<0.0001 vs 18% placebo) and also succeeded on the key secondary endpoint of mean proptosis change from baseline. Q8W showed even higher 63% PRR. Notably, Q4W achieved complete diplopia resolution in 51% of patients versus 16% placebo, addressing a key symptom in TED. Safety was favorable with low rates of hearing impairment across doses. These results position elegrobart as a potential first subcutaneous autoinjector for TED, offering convenience over existing IV therapies requiring eight infusions. REVEAL-2 in chronic TED remains on track for Q2 2026 topline data, supporting a planned Q1 2027 BLA submission. The company's $875 million cash as of December 31, 2025, plus potential $75 million DRI milestone on veligrotug U.S. approval and future revenues, funds operations through profitability. Veligrotug's PDUFA is June 30, 2026, enhancing the TED portfolio's value.