Every material Form 8-K Viridian Therapeutics, Inc.\DE has filed with the SEC since June 26, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Viridian Therapeutics reported positive phase 1 results for VRDN-008, an extended half-life FcRn inhibitor given subcutaneously, in six healthy volunteers. The company plans to focus its FcRn clinical development on VRDN-008 and to start at least one pivotal trial in 2027, beginning with myasthenia gravis in mid-2027, pending regulatory feedback.
Six healthy volunteers; IgG reduction of 74% at peak and sustained through eight weeks after subcutaneous dosing
Extended half-life of 15 to 18 days, five to six times longer than first-generation Fc fragments
First pivotal trial planned to start in mid-2027 in myasthenia gravis, pending regulatory feedback
Company plans to focus FcRn development on VRDN-008 and may pursue VRDN-006 in the future
Viridian Therapeutics reported third quarter 2026 results for the period ended September 30, 2026. Net product revenue from Lumvoa, its thyroid eye disease treatment in early launch, was $24.7 million, compared with no product revenue a year earlier, but the net loss widened to $101.2 million from $34.6 million as selling, general and administrative and related costs rose. Cash, cash equivalents, and marketable securities were $955.2 million at quarter end.
Lumvoa net product revenue was $24.7 million in the quarter, with more than 100 patients on therapy at the end of Q3 2026.
Net loss was $101.2 million, or $0.81 per share, versus $34.6 million, or $0.34 per share, in the same quarter of 2025.
SG&A expenses rose to $57.6 million from $24.3 million, while R&D expenses fell to $70.1 million from $86.3 million.
Cash, cash equivalents, and marketable securities were $955.2 million as of September 30, 2026; the elegrobart BLA submission is on track for Q1 2027.
Viridian Therapeutics reported second quarter 2026 results, its first full quarter after the June 26, 2026 FDA approval of Lumvoa for thyroid eye disease. Total revenues were $284 thousand, up from $75 thousand a year earlier, but the net loss widened to $127.1 million from $100.7 million, and selling, general and administrative expenses rose to $55.0 million from $20.2 million to build out commercial infrastructure.
Net loss was $127.1 million, or $1.05 per share, versus $100.7 million, or $1.00 per share, in the second quarter of 2025.
Total revenues were $284 thousand versus $75 thousand a year earlier.
Selling, general and administrative expenses were $55.0 million versus $20.2 million; research and development expenses fell to $71.6 million from $86.6 million.
Cash, cash equivalents and marketable securities were $981.5 million as of June 30, 2026, after convertible debt and equity financing in May 2026 with gross proceeds of $394 million.
The FDA approved Viridian Therapeutics' Lumvoa (veligrotug-vvze) for thyroid eye disease regardless of disease activity or duration, and the company plans to launch it immediately. The approval is Viridian's first FDA-approved product and first commercial product, a milestone that moves the company from development toward sales.
FDA approval announced June 26, 2026; Lumvoa is the first TED treatment with labeling covering both active and chronic TED
Launch planned immediately; physicians can prescribe Lumvoa tomorrow, per the press release
Lumvoa is given as five intravenous infusions over 12 weeks; infusion reactions reported in about 9% of patients
Conference call and webcast scheduled Monday, June 29, 2026 at 8:00 a.m. ET
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