Veligrotug shows sustained efficacy in thyroid eye disease trial

Published 20/05/2025, 12:06
Veligrotug shows sustained efficacy in thyroid eye disease trial

WALTHAM, Mass. - Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company with a market capitalization of approximately $1 billion, reported positive long-term results from its phase 3 THRIVE clinical trial for veligrotug, a treatment for thyroid eye disease (TED). The study showed that 70% of patients who responded to the treatment at week 15 maintained their response at week 52. According to InvestingPro data, while the company maintains strong liquidity with a current ratio of 19.49, it faces significant cash burn challenges typical of clinical-stage biotech firms.

The THRIVE trial assessed the efficacy of veligrotug, an anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, administered intravenously in patients with active TED. The primary analysis at week 15 was followed by an extended observation up to week 52. Maintenance of response was defined as a sustained reduction of at least 2 millimeters in proptosis, a symptom of TED, without worsening in the fellow eye. For investors tracking this development, InvestingPro reveals that analysts have set price targets ranging from $19 to $61, reflecting varied expectations about the company’s potential.

Safety profiles remained consistent with previous findings, with the majority of adverse events reported by week 15 resolved by the end of the 52-week period. Viridian’s President and CEO, Steve Mahoney, expressed confidence in veligrotug’s clinical profile, suggesting the potential of the drug to become a leading therapeutic option for TED if approved.

Veligrotug has already received Breakthrough Therapy Designation, which could expedite the review process. The company is on track to submit a Biologics License Application in the second half of 2025 and is actively preparing for a potential commercial launch in the U.S. in 2026.

The THRIVE and THRIVE-2 phase 3 trials, which also included chronic TED patients, marked the largest pivotal program for the disease to date. Veligrotug met all primary and secondary endpoints, demonstrating significant improvement and resolution of diplopia, a form of double vision associated with TED.

The positive results reinforce Viridian’s position as it prepares to introduce VRDN-003, its subcutaneous IGF-1R antibody for TED. The company is advancing multiple candidates for the treatment of TED, with ongoing global phase 3 pivotal clinical trials for VRDN-003.

Viridian Therapeutics continues to develop its portfolio, which includes a range of potential treatments for serious and rare diseases. The company’s focus remains on leveraging its expertise in antibody discovery and protein engineering to create differentiated therapeutic options. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates rapid cash consumption and analysts anticipate a sales decline in the current year. Discover more insights about VRDN’s financial health and growth prospects through InvestingPro’s comprehensive research reports, available for over 1,400 US stocks.

This news report is based on a press release statement from Viridian Therapeutics.

In other recent news, Viridian Therapeutics has received Breakthrough Therapy Designation from the FDA for veligrotug, a treatment for thyroid eye disease (TED). This designation follows the drug’s successful performance in phase 3 clinical trials, which showed significant improvements in patients with TED. The company plans to submit a Biologics License Application (BLA) for veligrotug in the second half of 2025, with a potential U.S. launch in 2026 if approved. Analysts at Stifel have maintained a Buy rating on Viridian, citing its progress towards becoming a commercial-stage entity and setting a price target of $41.00. They highlighted veligrotug’s competitive edge in the TED market due to its efficacy and fewer required doses compared to existing treatments. Viridian’s first-quarter results showed a narrower-than-expected loss of $0.87 per share, beating estimates, with revenue surpassing expectations at $70,000. Research and development expenses increased to $76.8 million as the company ramped up clinical trials, ending the quarter with $636.6 million in cash and investments. The company also appointed Jeff Ajer to its Board of Directors, signaling preparations for a potential commercial launch.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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