WALTHAM, Mass. - Viridian Therapeutics, Inc. (NASDAQ: VRDN), currently valued at $1.4 billion, today reported positive outcomes from the THRIVE-2 phase 3 clinical trial for veligrotug, an intravenous treatment for chronic thyroid eye disease (TED). The study met all primary and secondary endpoints, with a significant proptosis responder rate (PRR) of 56% and a diplopia responder rate of the same percentage, both showing a rapid onset of response. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet.
The trial enrolled 188 patients, with 125 receiving veligrotug and 63 on placebo. Results indicated a 48% placebo-adjusted PRR (p
Veligrotug was generally well-tolerated, with 94% of patients completing their treatment course. The treatment resulted in a 9.6% placebo-adjusted rate of hearing impairment adverse events.
Viridian anticipates a Biologics License Application (BLA) submission for veligrotug in the second half of 2025, with the potential to transform the standard of care in TED. Beyond veligrotug, Viridian is also advancing VRDN-003, a subcutaneous anti-IGF-1R antibody sharing the same binding domain, which is currently in two global phase 3 trials with topline data expected in the first half of 2026.
The company remains in a strong financial position, with a cash reserve of $753 million as of September 30, 2024, expected to fund operations into the second half of 2027, encompassing the commercial launch of veligrotug, topline results, and BLA submission for VRDN-003, along with other clinical developments. The stock has shown impressive momentum with a 43% gain over the past six months, though InvestingPro analysis indicates current trading levels may be above Fair Value. Analysts maintain an optimistic outlook, with price targets ranging from $22 to $61.
For investors seeking deeper insights, InvestingPro offers comprehensive analysis with 8 additional ProTips and a detailed Pro Research Report, providing valuable context for this development stage biotech company. Viridian will be hosting a conference call today at 8:00 a.m. ET to discuss the THRIVE-2 topline data. This announcement is based on a press release statement.
In other recent news, Viridian Therapeutics has made significant strides in its clinical trials for thyroid eye disease (TED) treatments. The biotechnology firm's lead asset, veligrotug, is currently in development as a therapy for TED and has shown promising results in its initial Phase III trial data. TD Cowen, Stifel, and Needham have initiated coverage on Viridian, issuing a Buy rating for the company's stock, citing the potential of veligrotug and the anticipation of additional data release.
Analyst firms such as Goldman Sachs and RBC Capital have also maintained their Buy ratings on Viridian, adjusting their price targets upwards. These ratings reflect a positive outlook on Viridian Therapeutics' stock, suggesting significant growth potential based on its current pipeline and the anticipated demand for its therapies.
In addition to veligrotug, Viridian Therapeutics is also advancing a subcutaneous program, VRDN-003, which is in Phase III development. This represents another avenue through which the company is seeking to address the needs of patients with TED.
Furthermore, Viridian has initiated a public offering of $150 million of its common stock and Series B non-voting convertible preferred stock. The proceeds from this offering will be used for clinical development programs, working capital, and general corporate purposes. These recent developments highlight Viridian's ongoing efforts in advancing treatments for TED.
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