Viridian Therapeutics, Inc.\DE

Viridian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED), regardless of activity or duration. Lumvoa is the first approved treatment for TED with labeling that includes data for both active and chronic TED, and Viridian plans to launch it immediately. The approval is supported by positive results from the THRIVE and THRIVE-2 pivotal Phase 3 clinical trials, which demonstrated rapid and significant improvements in TED symptoms.

Viridian Therapeutics, Inc. announced the voluntary prepayment of approximately $55.1 million, covering all outstanding principal, accrued interest, fees, and expenses under its Loan and Security Agreement. This action, completed on May 27, 2026, resulted in the full satisfaction and discharge of all company obligations and the termination of the Loan Agreement. The original agreement, entered into with Hercules Capital, Inc. and other lenders, provided for a term loan with aggregate maximum borrowings of up to $300 million, of which the company had borrowed $50 million.

Viridian Therapeutics has entered into a Commercial Manufacturing Services Agreement with WuXi Biologics (Hong Kong) Limited. Under the agreement, WuXi Biologics will serve as a non-exclusive supplier for the anticipated long-term commercial supply of veligrotug drug substance and drug product, pending approval. The agreement has an initial five-year term with automatic renewals, features volume-based pricing, and includes provisions for rolling forecasts and termination under specific conditions.

Viridian Therapeutics, Inc. completed its public offering of $250 million aggregate principal amount of 1.75% Convertible Senior Notes due 2032, including the full exercise of the underwriters' over-allotment option. The notes, issued on May 11, 2026, are unsecured senior obligations accruing interest semiannually. They are convertible under specific conditions at an initial rate of 40.5680 shares per $1,000 principal, representing an initial conversion price of approximately $24.65 per share, and are redeemable by the company from May 20, 2030, under certain stock price conditions.

Viridian Therapeutics announced positive topline data from its Phase 3 REVEAL-2 clinical trial for elegrobart in patients with chronic thyroid eye disease (TED). The trial met its primary endpoint with highly statistically significant proptosis responder rates for both Q4W and Q8W dosing regimens, and also showed significant improvement in diplopia. Elegrobart was generally well tolerated, and the company plans to submit a BLA in Q1 2027, aiming to offer the first subcutaneous autoinjector for TED. This follows positive results from the REVEAL-1 trial in active TED and precedes the anticipated June 30, 2026 PDUFA date for veligrotug.

Viridian Therapeutics reported a net loss of $(104.9) million for Q1 2026, an increase from $(86.9) million in Q1 2025, primarily due to higher operating expenses. The company maintains a strong liquidity position with $762.2 million in cash, cash equivalents, and marketable securities as of March 31, 2026. Key pipeline advancements include upcoming data from REVEAL-2 phase 3 trial for elegrobart in Q2 2026 and phase 1 data for VRDN-008 in H2 2026, alongside ongoing regulatory reviews for veligrotug.

Viridian Therapeutics reported its first-quarter 2026 financial results and significant progress across its pipeline. The company announced positive topline data from both pivotal Phase 3 REVEAL-1 and REVEAL-2 clinical trials for elegrobart in active and chronic Thyroid Eye Disease (TED), respectively, with a Biologics License Application (BLA) submission anticipated in Q1 2027. Additionally, veligrotug has a PDUFA target action date of June 30, 2026, and the company is launch-ready. For Q1 2026, Viridian reported a net loss of $104.9 million and held $762.2 million in cash, cash equivalents, and short-term investments.