WALTHAM, Mass. - Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company, announced positive results from its phase 3 THRIVE trial of veligrotug, an anti-IGF-1R antibody for thyroid eye disease (TED). The trial met all primary and secondary endpoints with a significant proptosis responder rate of 70% at week 15, compared to a 5% response in the placebo group.
The study, which involved 113 patients, also reported a 54% complete resolution of diplopia in veligrotug-treated patients, a substantial improvement over the 12% resolution in the placebo cohort. Additionally, 64% of patients treated with veligrotug saw a reduction of the Clinical Activity Score to 0 or 1, indicating minimal disease activity.
Veligrotug was well-tolerated with no serious adverse events related to treatment. However, a 5.5% placebo-adjusted rate of hearing impairment was noted. The THRIVE-2 study, focusing on chronic TED, is fully enrolled, with results expected by the end of 2024. A Biologics License Application (BLA) submission is anticipated in the second half of 2025.
Viridian also initiated two global phase 3 trials, REVEAL-1 and REVEAL-2, in August for VRDN-003, a subcutaneous form of the antibody with an extended half-life, targeting the same binding domain as veligrotug.
Financially, Viridian reported $571.4 million in cash, cash equivalents, and short-term investments as of June 30, 2024, expected to fund operations into the second half of 2026.
Viridian is hosting a conference call today to discuss the THRIVE topline data.
This report is based on a press release statement.
In other recent news, Viridian Therapeutics has been making significant progress in its clinical trials for thyroid eye disease (TED) treatments, VRDN-001 and VRDN-003. The company has completed enrollment for its Phase 3 trial of VRDN-001, with top-line results expected in September 2024. Viridian's VRDN-003 program is also set to enter pivotal trials following a positive Type C meeting with the FDA.
In addition to these developments, the company plans to initiate two critical trials, REVEAL-1 and REVEAL-2, for VRDN-003 in August 2024. These trials aim to test different dosing regimens for the treatment of both active and chronic TED patients. Analyst firms, including Goldman Sachs (NYSE:GS), RBC Capital, and Wolfe Research, project potential revenue from VRDN-001 to reach approximately $690 million worldwide by 2027.
Several analyst firms have maintained their positive ratings on Viridian. Needham, Goldman Sachs, H.C. Wainwright, and BTIG have all reiterated their Buy ratings, while RBC Capital has held its Outperform rating. These ratings reflect the firms' confidence in Viridian's ongoing trials and the potential of its TED treatments.
These are recent developments in the company's ongoing efforts to establish a strong presence in the TED market with innovative treatment options. As the trials progress, Viridian Therapeutics remains a company of interest for investors. The analysts' positive ratings and revenue projections reflect confidence in the company's direction and potential.
InvestingPro Insights
In light of Viridian Therapeutics' recent clinical success, insights from InvestingPro provide a nuanced perspective on the company's financial health and market performance. As of the last twelve months ending Q2 2024, Viridian holds a market capitalization of approximately $906.6 million, reflecting the market's valuation of the company post its clinical trial announcements. Despite the clinical progress, Viridian's revenue has seen a significant contraction, with a decline of 80.41%, indicating challenges in revenue generation and potential market skepticism about the immediate financial impact of the trial results.
The company's financial strength is highlighted by the fact that it holds more cash than debt on its balance sheet, according to an InvestingPro Tip, which suggests a robust liquidity position to fund ongoing operations and research. However, analysts have concerns about the company's profitability, with a consensus indicating that Viridian is not expected to be profitable this year and has been quickly burning through its cash reserves.
InvestingPro also notes that the company's gross profit margins are weak, with the last twelve months showing a gross profit margin of -57041.32%. This could be a point of concern for investors looking for sustainable financial performance. Additionally, Viridian does not pay a dividend, which may influence investment decisions for income-focused shareholders.
For those interested in exploring further insights, InvestingPro offers additional tips on Viridian Therapeutics, which can be found at https://www.investing.com/pro/VRDN. These tips provide a deeper dive into the company's financial metrics and analyst expectations, helping investors make more informed decisions.
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