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Viridian Therapeutics (NASDAQ:VRDN) presented its corporate strategy and pipeline progress in its August 2025 corporate presentation, highlighting positive Phase 3 data for its lead thyroid eye disease (TED) candidate veligrotug and outlining plans for a Biologics License Application (BLA) submission in the second half of 2025.
Executive Summary
Viridian is advancing a portfolio of treatments for TED and autoimmune diseases, with its lead candidate veligrotug demonstrating positive results in two Phase 3 trials for both active and chronic TED. The company plans to submit a BLA in the second half of 2025, with potential U.S. launch in the second half of 2026 if approved.
The company is also developing VRDN-003, a subcutaneous version of its anti-IGF-1R antibody, with pivotal trials ongoing and topline data expected in the first half of 2026. Additionally, Viridian is expanding beyond TED with its FcRn-targeting autoimmune portfolio, including VRDN-006 and VRDN-008.
As shown in the following pipeline overview, Viridian has built a diverse portfolio targeting both TED and broader autoimmune conditions:
Pipeline and Development Progress
Viridian’s lead candidate veligrotug has completed two Phase 3 trials - THRIVE in active TED and THRIVE-2 in chronic TED - both meeting their primary and secondary endpoints with statistical significance. The company received Breakthrough Therapy Designation in May 2025 and is preparing for BLA submission in the second half of 2025.
The company’s presentation highlighted several upcoming catalysts across its portfolio, including regulatory submissions, clinical trial readouts, and potential commercial launch:
Veligrotug demonstrated strong efficacy in the THRIVE trial, with 70% of patients achieving the primary endpoint of proptosis response (reduction in eye bulging) compared to just 5% on placebo. The drug also showed significant improvements in diplopia (double vision), with 54% of patients achieving complete resolution versus 12% on placebo.
As shown in the following chart, the onset of treatment effect was rapid, with 53% of patients achieving proptosis response after just one infusion at week 3:
In the THRIVE-2 trial for chronic TED, veligrotug also demonstrated statistically significant improvements across all primary and secondary endpoints. Notably, this was the first pivotal Phase 3 study to demonstrate statistically significant diplopia response and resolution in chronic TED.
The following slide summarizes the key results from both the THRIVE and THRIVE-2 trials:
Market Opportunity (SO:FTCE11B)
Viridian estimates the current TED market at approximately $2 billion annually, with significant growth potential. According to the company, only about 15,000 patients have been treated to date out of an estimated 190,000 people in the U.S. with moderate to severe TED.
The company believes veligrotug is well-positioned to become the intravenous treatment of choice for TED, while its subcutaneous candidate VRDN-003 could potentially expand the market further by offering a more convenient administration option.
As shown in the following slide, Viridian has identified key commercial advantages for veligrotug:
Thyroid Eye Disease Overview
TED is an autoimmune condition characterized by inflammation, growth, and damage to tissues around and behind the eyes. It can cause symptoms including proptosis (eye bulging), redness, swelling, diplopia (double vision), and in severe cases, sight-threatening optic nerve compression.
The following slide provides a visual overview of TED and its effects:
Financial Position
Viridian reported $563 million in cash as of June 30, 2025, providing runway into the second half of 2027. This represents a slight decrease from the $613 million reported in Q1 2024, reflecting ongoing investment in clinical development programs.
The company has also secured an exclusive license agreement with Kissei Pharmaceutical (TADAWUL:2070) to develop its TED portfolio in Japan, receiving $70 million upfront with potential for $315 million in additional milestones and royalties in the 20s to mid-30s percentage range.
Forward-Looking Statements
Viridian outlined several key upcoming milestones:
1. BLA submission for veligrotug in the second half of 2025
2. EU Marketing Authorization Application (MAA) submission in the first half of 2026
3. Potential U.S. launch in the second half of 2026, if approved
4. Topline data from REVEAL-1 and REVEAL-2 trials for VRDN-003 in the first half of 2026
5. Healthy volunteer data for VRDN-006 in Q3 2025
6. IND submission for VRDN-008 by year-end 2025
The company’s stock closed at $17.44 on August 6, 2025, down 1.38% for the day, but showed a 4.36% gain in after-hours trading. The stock has traded between $9.90 and $27.20 over the past 52 weeks.
Viridian’s presentation positions the company for potential commercial transition in 2026, with plans to build a leadership position in autoimmune disease through its TED portfolio and expanding FcRn-targeting programs.
Full presentation:
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