Just days before ringing in 2026, the FDA accepted Viridian Therapeutics, Inc’s Biological License Application (BLA) submission of veligrotug for the treatment of thyroid eye disease (TED).
First things first: a refresh on veli is in order.
Certainly. This investigational candidate is formulated as an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody.
What it does: Blocks cell surface receptor activity and targets antibody and protein engineering for specific diseases such as TED.
- Check out this coverage for more details on how and why IGF-1Rs are clinically-validated targets for TED.
And how does it work?
Veli is intended to reduce TED-associated tissue swelling and inflammation via five 30-minute, intravenous (IV) infusions administered 3 weeks apart.
The intent: For TED patients to complete treatment in 12 weeks.
Next up: Viridian’s BLA submission.
As we’ve previously reported, veli’s BLA is based on clinical data from two pivotal phase 3 trials that evaluated the therapeutic’s safety and efficacy among patients with chronic and active TED.
- See here for info (including positive findings) on the THRIVE and THRIVE-2 studies.
What to know: Veli was determined to be generally well tolerated and demonstrated “a rapid onset of clinical benefit and statistically significant and meaningful effect on multiple diplopia endpoints.”
- And as a bonus: 52-week outcomes on its long-term durability—first reported in May 2025—among proptosis responders can be found here.
Now to this acceptance.
Did we mention that, when submitting its BLA, Viridian also requested priority review?
Well, the company did (and was enabled to do so after veli received Breakthrough Therapy designation earlier in 2025.
- Importantly, priority review shortens the FDA’s review period of a therapeutic intended to treat a serious disease or condition to just 6 months.
So … did the FDA grant priority review as well?
Indeed, it did.
As Viridian President and CEO Steve Mahoney noted, the milestone designation is recognition that, if approved, veli “would be a significant improvement in the safety or effectiveness of treating a serious condition” such as TED.
Not to mention veli’s potential approval would not only prove beneficial for TED patients, but also establish Viridian as a leading commercial company for the eye disease.
And in terms of timing, what does this mean for a potential approval decision?
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026.
Plus, outside of the United States: Viridian shared plans to submit a marketing authorization application to the European Medicines Agency (EMA) sometime in Q1 2026.