Viridian Therapeutics reported early commercial momentum for its Lumvoa intravenous therapy and provided updated development milestones during a presentation at Wells Fargo’s annual healthcare conference on September 8.
President and CEO Steve Mahoney said the company has engaged approximately 95% of a targeted group of 2,000 core prescribers—accounting for roughly 80% to 90% of all TEPEZZA scripts—within six weeks of launch. The firm also noted that preliminary authorizations via the medical exception process for high-priced biologics typically take 60 to 90 days, with Lumvoa expected toward the longer end initially.
The presentation highlighted the size of the addressable market in thyroid eye disease. An estimated 200,000 U.S. patients have moderate to severe disease, divided into roughly 40,000 in the active phase and 160,000 in the chronic phase. About 6,000 patients are treated annually across both groups, with TEPEZZA generating estimated chronic-phase sales of $500 million per year.
Mahoney emphasized that the chronic population represents a significant expansion opportunity beyond the active-disease segment.
Lumvoa is administered as five 10 mg/kg infusions over a 12-week course, compared with TEPEZZA’s eight infusions at 20 mg/kg across 21 weeks. Payer coverage data showed the existing product reaches approximately 85% of covered lives, a footprint established over five to six years. Management indicated payers have signaled expectations for parity pricing and coverage for the new therapy.
Financial metrics cited by InvestingPro data showed Viridian holding more cash than debt, with a current ratio of 16.95. Shares traded at $23.78, up 3.75% from the prior close of $22.92, within a 52-week range of $13.18 to $34.29.
Pipeline updates covered three programs. A subcutaneous version of the antibody, developed under the name elegrobart, is expected to receive a biologics license application submission in the first quarter of 2027. Top-line efficacy and safety data from a 52-week study will be disclosed at the 24-week mark, with patients ceasing treatment at week 21.
The TSHR antagonist program is targeting an investigational new drug submission in the fourth quarter of 2024, with clinical entry anticipated in early 2025. Data from a separate extended half-life FcRn program is expected in 2024.
Lumvoa received FDA approval on June 26, 2024, four days ahead of its prescribed drug user fee act date. A permanent J-code is expected on January 1, 2025, following a submission made before July 1. Third-quarter earnings are scheduled for release in November.
