VRDN
Published on 06/06/2025 at 14:43
June 2025
3
Veligrotug
Intravenous
VRDN-003
Subcutaneous
DISCOVERY
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
STATUS
Reported positive topline data; BLA planned 2H 2025
Pivotal trials ongoing
VRDN-006
FcRn-targeting Fc fragment
VRDN-008
Bispecific, extended half-life FcRn inhibitor
Phase 1 study ongoing; HV data expected Q3 2025
IND submission planned YE 2025
BLA = Biologics License Application, Fc = fragment crystallizable, FcRn = neonatal Fc receptor, IGF-1R = insulin-like growth factor-1 receptor, IND = Investigational New Drug, TED = thyroid eye disease, YE = year-end.
Anticipated Catalysts
Veligrotug
Intravenous
BLA submission: 2H 2025
EU MAA submission: 1H 2026
U.S. launch, if approved: 2H 2026
VRDN-003
Subcutaneous
Topline data for both trials: 1H 2026
BLA submission: Year-end 2026
FcRn Portfolio
Healthy volunteer data: Q3 2025
IND submission: Year-end 2025
Financial
Positive THRIVE and THRIVE-2 topline data in active and chronic TED showed a robust clinical profile1
Strong durability of proptosis response in THRIVE
Breakthrough Therapy Designation granted May 2025
Believe veligrotug is well-positioned to become the IV treatment-of-choice in TED
REVEAL-1 and REVEAL-2 enrolling and dosing patients
VRDN-006 proof-of-concept Phase 1 clinical trial on track
VRDN-008 on track for IND submission year-end 2025
$637M cash as of March 31, 2025
Runway into 2H 2027
Source: 1 Viridian THRIVE & THRIVE-2 data on file. 2
BLA = Biologics License Application, FcRn = neonatal Fc receptor, IND = Investigational New Drug, IV = intravenous, MAA = Marketing Authorization Application, PDUFA = Prescription Drug User Fee Act, TED = thyroid eye disease.
Disclaimer
Viridian Therapeutics Inc. published this content on June 06, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on June 06, 2025 at 18:42 UTC.