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Viridian Therapeutics(VRDN) - 2025 Q2 - Earnings Call Presentation
2025-08-06 20:00
Thyroid Eye Disease (TED) Portfolio - Veligrotug's BLA submission is planned for the second half of 2025, with a potential U S launch in the second half of 2026, and the EU MAA submission is planned for the first half of 2026[13] - Topline data for VRDN-003's REVEAL-1 and REVEAL-2 trials are expected in the first half of 2026, with a BLA submission planned by year-end 2026[13] - In the THRIVE trial for active TED, the proptosis responder rate at week 15 was 70% for patients receiving veligrotug compared to 5% on placebo (p < 0 0001)[56, 58] - In the THRIVE-2 trial for chronic TED, the proptosis responder rate at week 15 was 56% for patients receiving veligrotug compared to 8% on placebo (p < 0 0001)[79] - 70% of proptosis responders in the THRIVE trial maintained their response at Week 52[69] FcRn Inhibitor Portfolio - VRDN-006 proof-of-concept Phase 1 clinical trial healthy volunteer data is expected in Q3 2025[13] - VRDN-008 is on track for IND submission by year-end 2025[13] - A single dose of VRDN-008 demonstrated a longer half-life and a ~20% deeper and more sustained reduction of IgG compared to efgartigimod in NHPs[149] - The market size of MG and CIDP alone are projected to be over $11 2 billion by 2030[133, 134] Corporate/Financial - Viridian had $563 million in cash as of June 30, 2025, providing a runway into the second half of 2027[13]
Viridian Therapeutics (VRDN) Earnings Call Presentation
2025-06-19 15:28
Thyroid Eye Disease (TED) Portfolio - Veligrotug (Intravenous) - Positive THRIVE and THRIVE-2 topline data in active and chronic TED showed a robust clinical profile[12] - In the THRIVE trial, 70% of patients receiving veligrotug achieved a proptosis response at 15 weeks, compared to 5% on placebo[57] - In the THRIVE trial, 53% of patients receiving veligrotug achieved a proptosis response at 3 weeks, after just 1 infusion[59] - In the THRIVE-2 trial (chronic TED), 56% of patients achieved a proptosis response compared to 8% in the placebo group[78] - Viridian plans to submit the BLA for veligrotug in the second half of 2025 and the EU MAA in the first half of 2026[3, 12] Thyroid Eye Disease (TED) Portfolio - VRDN-003 (Subcutaneous) - REVEAL-1 and REVEAL-2 trials are enrolling and dosing patients, with topline data expected in the first half of 2026[12] - The BLA submission for VRDN-003 is anticipated by year-end 2026[3, 12] - Phase 1 HV Study showed VRDN-003 has an extended half-life of 40–50 days and increases IGF-1 levels ~4-fold[102, 104] FcRn Inhibitor Portfolio - VRDN-006 proof-of-concept Phase 1 clinical trial data is expected in Q3 2025[3, 12] - VRDN-008 is on track for IND submission by year-end 2025[3, 12] - A single dose of VRDN-008 demonstrated a longer half-life and deeper IgG reduction compared to efgartigimod in NHPs[148, 149] Financial - Viridian had $637 million in cash as of March 31, 2025, providing a runway into the second half of 2027[12]