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Viridian Therapeutics Receives FDA Approval for Lumvoa to Treat Thyroid Eye Disease
Viridian Therapeutics announced that the U.S. FDA has approved Lumvoa for the treatment of thyroid eye disease. TED is a rare, debilitating autoimmune disease characterized by inflammation and tissue remodeling around and behind the eyes that can lead to proptosis, diplopia, pain, and vision impairment.
Deal Size Increased to $125M in Common Stock
The deal size was increased to $125M in common stock from $100M in common stock. Jefferies, Leerink and Goldman Sachs acted as joint book running managers for the offering.
Viridian Therapeutics Launches $150M Convertible Notes and $100M Stock Offering
Viridian Therapeutics announced that it has commenced underwritten public offerings of $150M aggregate principal amount of convertible senior notes due 2032 and $100M of shares of its common stock and, in lieu of common stock to certain investors, shares of its Series B non-voting convertible preferred stock. Jefferies, Leerink Partners, and Goldman Sachs & Co. are acting as joint book-running managers and LifeSci Capital is acting as lead manager for the proposed convertible notes offering. Jefferies, Leerink Partners, and Goldman Sachs & Co. are acting as joint book-running managers and LifeSci Capital and Wedbush PacGrow are acting as lead managers for the proposed equity offering.
Viridian Therapeutics Announces Positive REVEAL-2 Trial Data
Viridian Therapeutics announced positive topline data from the REVEAL-2 phase 3 clinical trial of elegrobart in patients with chronic thyroid eye disease, TED. Elegrobart is a subcutaneously delivered, half-life-extended monoclonal antibody targeting the insulin-like growth factor-1 receptor. REVEAL-2 evaluated two dosing regimens, every four weeks and every eight weeks, compared with placebo. Key Highlights: REVEAL-2 met its primary endpoint with a highly statistically significant treatment effect; Elegrobart Q4W and Q8W achieved 50% and 54% proptosis responder rates at week 24, respectively, versus 15% placebo, both highly statistically significant results; Elegrobart Q4W achieved a statistically significant 61% diplopia responder rate at week 24, versus 38% placebo ; Elegrobart was generally well tolerated in both dose groups, with a safety profile consistent with REVEAL-1 and low rates of hearing impairment; Elegrobart is the only subcutaneous program to demonstrate positive phase 3 data in both active and chronic TED pivotal clinical trials and has the potential to be the first autoinjector treatment for TED; BLA submission on track for Q1 2027
Viridian Therapeutics Q1 Revenue $141K, Exceeds Expectations
Reports Q1 revenue $141k, consensus $27.75k. "Our team continues its strong execution across our portfolio as we are launch ready ahead of veligrotug's PDUFA target date. We delivered positive topline data from both of elegrobart's pivotal REVEAL phase 3 clinical trials, and earlier programs are moving ahead as planned," said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. "With veligrotug's PDUFA target date next month, we have hired and deployed our full field teams, readied commercial supply and supply chain infrastructure, and continue to engage physicians, payers, and key opinion leaders. We believe we are well-prepared and well-positioned to deliver a successful launch. With the positive topline data from REVEAL-1 and REVEAL-2, in active and chronic TED, respectively, we believe that subcutaneous elegrobart has the potential to be the simplest and most convenient treatment for TED."
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