VRDN-008 / Viridian Therap - LARVOL DELTA

VRDN‑008: IND cleared and phase 1 clinical trial initiated (Businesswire) - "VRDN-008 IND cleared in January 2026. Phase 1 clinical trial in healthy volunteers is now enrolling participants; data expected in 2H 2026."

IND • P1 data • Trial status • Immunology

VRDN-008 IND on Track for Year-End 2025. (FinancialContent) - "As previously disclosed, after a single, high dose head-to-head study in non-human primates, VRDN-008 showed a longer half-life and more sustained IgG reduction versus efgartigimod. Healthy volunteer data are expected for VRDN-008 in 2H 2026."

IND • Preclinical • Immunology

Viridian Therapeutics Highlights Recent Progress and Reports First Quarter 2025 Financial Results (Businesswire) - "Biologics License Application (BLA) submission for veligrotug on track for second half 2025 with potential for U.S. launch in 2026; preparatory commercial activities underway; REVEAL-1 and REVEAL-2, phase 3 clinical trials assessing VRDN-003 in active and chronic thyroid eye disease (TED), are on track for topline data in the first half of 2026....VRDN-008, a bispecific neonatal Fc receptor (FcRn) inhibitor with an extended half-life, on track for an Investigational New Drug (IND) submission for year-end 2025."

FDA filing • IND • Launch US • P3 data: top line • Ophthalmology • Thyroid Eye Disease

Viridian Therapeutics Highlights 2025 Corporate Priorities... (Businesswire) - "VRDN-008, a bispecific FcRn inhibitor with an extended half-life, progressing with preclinical studies as planned; additional preclinical data expected in 2025 with an IND submission planned for year-end 2025..."

IND • Preclinical • Immunology