• Organizations: Viridian Therapeutics
FDA accepts Viridian's veligrotug BLA for TED
Pipeline

FDA accepts Viridian's veligrotug BLA for TED

Therapeutic also receives priority review, enabling a PDUFA target action date for the end of June 2026.
Viridian submits BLA for veligrotug to treat TED
Pipeline

Viridian submits BLA for veligrotug to treat TED

Company is requesting Priority Review of veli, an IGF-1R monoclonal antibody intravenously-administered to treat chronic TED.
Viridian reports long-term durability data, secures FDA designation for TED therapy
Pipeline

Viridian reports long-term durability data, secures FDA designation for TED therapy

After receiving FDA Breakthrough Therapy designation, new 52-week data finds 70% of proptosis responders at Week 15 maintained their response.
Viridian reports positive phase 3 data on veligrotug for chronic TED
Pipeline

Viridian reports positive phase 3 data on veligrotug for chronic TED

Latest THRIVE-2 study findings detail a favorable safety profile, shorter dosing regimen, and a promising diplopia response and resolution rate.
Viridian reports positive topline data from phase 3 TED trial
Pipeline

Viridian reports positive topline data from phase 3 TED trial

VRDN-001 (now veligrotug) achieves all primary and secondary endpoints as company plans to submit a BLA in 2025. 
Viridian completes patient enrollment for THRIVE-2 chronic TED trial
Pipeline

Viridian completes patient enrollment for THRIVE-2 chronic TED trial

Second phase 3 trial in the IGF-IR pipeline is evaluating VRDN-001, previously reported to reduce disease signs and symptoms after just two infusion sessions. 
Viridian to initiate two phase 3 studies for chronic TED
Pipeline

Viridian to initiate two phase 3 studies for chronic TED

VRDN-003, an IGF-IR monoclonal antibody, will be evaluated as a subcutaneous injection administered every 4 or 8 weeks.
Viridian reports positive data from ongoing trial of VRDN-001 for chronic TED
Business

Viridian reports positive data from ongoing trial of VRDN-001 for chronic TED

Safety and tolerability profile matches with previous data; company shares plans for subcutaneous program.
Positive data reported in ongoing phase 1/2 trial of VRDN-001 for TED
Research

Positive data reported in ongoing phase 1/2 trial of VRDN-001 for TED

Viridian Therapeutics announced the release of positive topline, 6-week data from its third, low-dose cohort.
Positive data reported in phase ½ trial of TED therapy
Pipeline

Positive data reported in phase ½ trial of TED therapy

Viridian Therapeutics released positive topline clinical data from 2 cohorts of its phase 1/2 clinical trial analyzing VRDN-001 for thyroid eye disease (TED).