VRDN Stock Jumps 6% After-Hours As Viridian Wins First FDA Approval

The FDA approved Viridian’s Lumvoa for the treatment of thyroid eye disease.

• Lumvoa is the first treatment approved for patients with TED regardless of whether the disease is in its active (early) or chronic (long-term) stage.
• Physicians can begin prescribing Lumvoa immediately, the company said.
• TED is a rare autoimmune condition that causes painful inflammation and swelling around the eyes, leading to bulging, double vision, discomfort, and in some cases, vision problems.

Shares of Viridian Therapeutics Inc (VRDN) jumped 6% after-hours on Friday after the U.S. Food and Drug Administration approved its drug Lumvoa for the treatment of thyroid eye disease.

The drug is now available by prescription and marks the company’s first approved medicine and first commercial product.

New Option For Active And Chronic Disease

TED is a rare autoimmune condition that causes painful inflammation and swelling around the eyes, leading to bulging, double vision, discomfort, and in some cases, vision problems. Lumvoa is the first treatment approved for patients with TED regardless of whether the disease is in its active (early) or chronic (long-term) stage.

Strong Results In Key Trials

The approval was based on two large late-stage studies — THRIVE in active TED and THRIVE-2 in chronic TED. In both trials, Lumvoa met all primary and secondary goals. Patients saw rapid reductions in eye bulging and double vision, with improvements beginning as early as three weeks. The drug is given as five intravenous infusions over 12 weeks.

Immediate Launch And Patient Support

Physicians can begin prescribing Lumvoa immediately, the company said. Viridian has launched ViridianCares, a patient support program that offers insurance navigation, financial assistance, and dedicated support staff to help eligible patients access treatment.

Company And Expert Reaction

“This approval represents a major step forward for people living with thyroid eye disease,” said Steve Mahoney, President and CEO of Viridian. “Lumvoa was designed with patients in mind and addresses a clear need across the full spectrum of the disease.”

In addition to Lumvoa, Viridian is advancing VRDN-003, a subcutaneous anti-IGF-1R antibody designed for self-administration via autoinjector. The company recently reported positive topline results from two pivotal late-stage trials in active and chronic thyroid eye disease.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around VRDN stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.

A Stocktwits user cheered the news as “massive” and recommended watching the stock next week.

According to data from Koyfin, 16 of the 17 analysts covering VRDN stock rate it ‘Buy’ or higher, while one rates it ‘Hold.’ The 12-month average price target on the stock is $33.94, representing a potential upside of about 90% from the last closing price.

VRDN stock is down 42% year-to-date. 

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