Shares of Viridian Therapeutics VRDN have gained 6.3% over the past week compared with the industry’s 5.5% growth. The upside came after the company announced that the FDA approved veligrotug, an IGF-1R antagonist, under priority review for the treatment of thyroid eye disease (TED).
Viridian will market the drug under the brand name Lumvoa in the United States. The approval, granted on June 26, 2026 — four days ahead of the June 30, 2026, PDUFA target action date — marks Viridian's transition into a commercial-stage biotechnology company with its first approved product.
Lumvoa's approval represents a significant milestone for both the company and the TED treatment landscape. It is the first FDA-approved therapy for TED with labeling that includes data in active and chronic disease, expanding treatment eligibility beyond patients with active TED alone. Viridian intends to commercialize the therapy immediately following the approval.
The company has expanded its global regulatory efforts, with the marketing authorization application for veligrotug in TED under review by the European Medicines Agency following its submission in January 2026. Last year, the FDA granted Lumvoa Breakthrough Therapy Designation, recognizing its potential to address a significant unmet medical need.
Lumvoa is administered as five intravenous infusions over a 12-week treatment course, with one infusion every three weeks.
TED is a rare autoimmune disorder that causes inflammation around the eyes, leading to eye bulging (proptosis), double vision, pain and vision impairment.
Strong Phase III Data Support VRDN's FDA Approval
Lumvoa's FDA approval was based on the positive data from the pivotal phase III THRIVE and THRIVE-2 studies for active and chronic TED, respectively, both of which met their primary and secondary endpoints. The therapy demonstrated rapid, statistically significant improvements in key TED symptoms, including proptosis as early as three weeks, diplopia response and complete resolution of diplopia in both active and chronic disease.
VRDN’s TED Pipeline Beyond Lumvoa
Beyond Lumvoa, the company has another pipeline candidate, elegrobart, the only subcutaneous program for patients with TED. Earlier, the company announced positive top-line data from two pivotal phase III studies (REVEAL-1 and REVEAL-2) for active and chronic TED, respectively. Both studies met their primary endpoints.
Viridian plans to submit a biologics license application to the FDA in the first quarter of 2027, seeking approval for every-four-week and every-eight-week dosing regimens of elegrobart. If approved, the company intends to launch elegrobart as the first at-home autoinjector therapy for thyroid eye disease, offering patients a more convenient treatment option.
Viridian Therapeutics, Inc. Price and Consensus
Viridian Therapeutics, Inc. price-consensus-chart | Viridian Therapeutics, Inc. Quote
VRDN’s Zacks Rank & Stocks to Consider
Viridian currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore IMCR, Amarin Corporation AMRN and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents per share. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 8.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
Over the past 60 days, loss per share estimates for Amarin have narrowed from $15.20 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $13.00 to 51 cents for 2027. AMRN shares have risen 14.6% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share (EPS) have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.92 from $2.91. LQDA shares have surged 131.1% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
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