FDA Approves Viridian's Lumvoa for Thyroid Eye Disease; Q2 2026 Results and Pipeline Progress

Lumvoa (veligrotug-vvze) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of thyroid eye disease (TED) on June 26, 2026, ahead of the target PDUFA date, and Viridian Therapeutics, Inc. immediately launched the drug in the U.S. The approval marks the company's transition into a commercial-stage biotechnology company.

The veligrotug BLA was under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026. The company said it was launch-ready, with field team hiring complete and commercial supply and supply chain infrastructure established. Veligrotug received Breakthrough Therapy Designation and Priority Review from the FDA in 2025. A Marketing Authorization Application (MAA) for veligrotug in TED was submitted to the European Medicines Agency (EMA) in January 2026 and accepted for review in February 2026.

For the second quarter ended June 30, 2026, Viridian completed a convertible debt and equity financing in May 2026 with gross proceeds of $394 million. Cash, cash equivalents, and marketable securities were $982 million as of June 30, 2026. As of March 31, 2026, cash, cash equivalents, and short-term investments were $762 million.

Early launch indicators were strong. As of July 31, 2026, the field sales team achieved engagement with 95% of the 2,000 core prescribing physicians, with strong and positive early feedback. The first doses of Lumvoa were administered in July, and patient enrollment forms to-date indicate broad and strong physician demand. ViridianCares, the company's patient support program, was activated at the time of approval.

Viridian is on track to submit a Biologics License Application (BLA) to the FDA for elegrobart in Q1 2027. Elegrobart has the potential to be the first low-volume, subcutaneous autoinjector for the treatment of TED that patients can self-administer at home, if approved. Positive topline results were reported from REVEAL-1 and REVEAL-2, two pivotal phase 3 clinical trials of subcutaneous elegrobart in active and chronic TED, respectively. At week 24 in both trials, Q4W and Q8W elegrobart demonstrated rapid and robust reductions in proptosis, and Q4W elegrobart additionally showed meaningful benefits for patients with diplopia. In REVEAL-1, the Q4W and Q8W treatment arms achieved 54% and 63% proptosis responder rates, respectively, versus 18% placebo at week 24. In REVEAL-2, the arms achieved 50% and 54% proptosis responder rates, respectively, versus 15% placebo at week 24. Elegrobart was generally well-tolerated, with a safety profile consistent with the anti-IGF-1R class and low rates of hearing impairment.

Viridian is developing a potential best-in-class, half-life extended, monoclonal anti-thyroid-stimulating hormone receptor (TSHR) antibody designed for subcutaneous delivery in an autoinjector, with an Investigational New Drug (IND) submission anticipated in Q4 2026 for development in TED and Graves' disease. In the FcRn portfolio, VRDN-008 phase 1 clinical trial in healthy volunteers is ongoing, with data on track for the second half of 2026. VRDN-008 previously showed a longer half-life and more sustained IgG reduction versus efgartigimod in a head-to-head study in non-human primates. VRDN-006 showed IgG reductions consistent with the FcRn inhibitor class, spared albumin and LDL, and was generally well-tolerated in a phase 1 healthy volunteer trial; development plans are expected to be shared in 2026.

Viridian is a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, based in Waltham, Massachusetts. The company conducted a pivotal program for veligrotug, including two global phase 3 clinical trials, THRIVE and THRIVE-2, which reported positive topline data, meeting their primary endpoints and all secondary endpoints.