On Tuesday, Viridian Therapeutics (NASDAQ:VRDN) received a reaffirmation of a Buy rating and a $27.00 stock price target from H.C. Wainwright.
The firm highlighted the progress of Viridian's key studies, particularly the THRIVE-1 trial for thyroid eye disease (TED), which is anticipated to deliver results in September 2024. Viridian recently provided an update, confirming that its pivotal studies for its leading TED program, VRDN-001 (IV), are advancing as planned.
The THRIVE-1 study, targeting active TED patients, completed patient enrollment in March 2024 and is set to present topline data in September 2024. Moreover, the THRIVE-2 study, which includes patients with chronic TED, achieved its enrollment target earlier this month and is expected to finalize enrollment by the end of July.
The company noted that this study is also likely to exceed its planned enrollment, with a significant portion of participants coming from the United States. This high enrollment rate underscores the demand for alternative treatments to Tepezza, the current market leader.
The topline data readout for the THRIVE-2 study is slated for the end of 2024. H.C. Wainwright believes that for both THRIVE-1 and THRIVE-2 studies, VRDN-001 needs to demonstrate efficacy and safety on par with Tepezza to be commercially successful. There is optimism that VRDN-001 could offer safety benefits due to fewer injections, although some hearing loss is expected, similar to Tepezza's side effects.
In addition to these pivotal studies, Viridian initiated the STRIVE study to fulfill the safety database requirements for a Biologics License Application (BLA) filing, which is planned for the second half of 2024. The STRIVE study's partial completion, expected by the second half of 2025, along with the patient enrollment numbers from THRIVE-1 and -2, positions Viridian for a potential product launch in the second half of 2026.
In other recent news, Viridian Therapeutics has made significant strides in its clinical trials. The company has completed enrollment for its Phase 3 trial of VRDN-001 for active thyroid eye disease (TED), with top-line results expected in the near future. Simultaneously, Viridian is advancing its subcutaneous VRDN-003 program, set to enter pivotal trials following a positive Type C meeting with the FDA.
Analyst firms have maintained an optimistic outlook on Viridian. Goldman Sachs (NYSE:GS) reiterated its Buy rating with a $23.00 price target, while RBC Capital and Wolfe Research both issued an Outperform rating. The latter projects a potential revenue of approximately $690 million worldwide by 2027 from VRDN-001.
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 reflect confidence in the company's direction and potential.
InvestingPro Insights
Amid the optimism surrounding Viridian Therapeutics' progress in its clinical trials, InvestingPro data presents a mixed financial picture. With a market cap of approximately $1.07 billion, Viridian is navigating a challenging financial landscape.
The company's revenue for the last twelve months as of Q1 2024 stands at a modest $0.29 million, which represents a significant decline of 82.59%. Moreover, the company's gross profit margin during the same period is deeply negative at -51,972.57%, indicating substantial costs relative to its revenue.
Still, it is not all bleak for Viridian. InvestingPro Tips highlight that the company holds more cash than debt, providing some financial stability. Additionally, Viridian's liquid assets exceed its short-term obligations, suggesting the company is well-positioned to manage its immediate financial responsibilities.
On the performance front, Viridian has seen a significant return over the last week, with a 19.04% price total return, which could indicate investor confidence in the company's future prospects despite its current financial challenges.
For those considering an investment in Viridian, it's worth noting that while analysts do not expect the company to be profitable this year, there are other factors at play that could influence its stock value. For more detailed analysis and additional InvestingPro Tips, interested parties can visit https://www.investing.com/pro/VRDN. Remember to use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. There are 9 additional InvestingPro Tips available for Viridian, which could further inform investment decisions.
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