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Get filing alertsViridian receives FDA approval for Lumvoa, first TED therapy covering active and chronic disease
Filed June 29, 2026 · Period ending June 26, 2026 · ~1 min read
Key Changes
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FDA approved Lumvoa for thyroid eye disease treatment regardless of activity or duration, making it the first approved TED therapy with labeling covering both active and chronic disease forms.
Item 8.01 — Other Events verify on EDGAR → -
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Viridian launching Lumvoa immediately with prescriptions available next day; marks company's transition from development to commercial stage.
Exhibit 99.1 verify on EDGAR → -
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Pivotal THRIVE trials met all primary and secondary endpoints with clinical benefits appearing as early as three weeks; Lumvoa first approved TED product showing statistically significant effects on diplopia in both active and chronic disease.
Exhibit 99.1 verify on EDGAR →
2 more material changes behind this preview — plus the full narrative summary, section-by-section diffs against the prior filing, and verbatim quotes with EDGAR citations.
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Generated by AI · Jun 30, 2026 12:26 AM