On Monday, Viridian Therapeutics, Inc. (NASDAQ:VRDN) received a reiterated Buy rating and a $46.00 stock price target from BTIG. The optimism is based on the progress of their THRIVE-2 trial for VRDN-001, a treatment for chronic thyroid eye disease (TED).
The trial has successfully reached its enrollment target of 159 patients and is expected to surpass this number by the completion of enrollment in July 2024. Over 40% of the trial’s participants are from the United States.
The company has confirmed that it is on schedule to provide a data readout around the end of 2024. This follows the completion of enrollment for the first pivotal trial, THRIVE, for acute TED in March, which also exceeded its enrollment target. THRIVE included 113 patients, half of whom were from the U.S., surpassing the initial goal of 90.
Management has expressed confidence in VRDN-001, citing comparable efficacy and safety to the existing TED treatment, Tepezza. They believe that VRDN-001’s dosing regimen, which requires fewer infusions, and a shorter infusion time, will be preferred by patients. They are aiming for a 70% proptosis responder rate to demonstrate efficacy comparable to Tepezza, based on previous teprotumumab studies.
In the United States, Tepezza’s net sales reached approximately $1.8 billion in 2023, treating around 15,000 TED patients out of an estimated 190,000 with moderate-to-severe conditions. Viridian’s management sees this as an opportunity to target a significant new patient population. Moreover, the potential introduction of a subcutaneous treatment option is expected to expand the total addressable market (TAM) even further.
Viridian plans to initiate pivotal trials for a subcutaneous version of their treatment, VRDN-003, for both acute and chronic TED in August. These trials, known as REVEAL-1 and -2, are part of the company’s broader strategy to provide innovative treatments for thyroid eye disease.
In other recent news, Viridian Therapeutics has made significant progress 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 September 2024. The firm is also progressing with its subcutaneous VRDN-003 program, set to enter pivotal trials following a positive Type C meeting with the FDA.
Several analyst firms have given their outlook on Viridian. Goldman Sachs maintained its Buy rating on Viridian shares with a $23 target, while RBC Capital reiterated an Outperform rating and a $35 target. Wolfe Research initiated coverage with an Outperform rating, projecting potential revenue of approximately $690 million worldwide by 2027 from VRDN-001.
These recent developments highlight the potential financial and therapeutic impact of Viridian’s lead drug candidates in the coming years. As the market looks forward to the possible success of VRDN-001 and VRDN-003, investor attention will likely be focused on the milestones and financial performance outlined by RBC Capital, Wolfe Research, and Goldman Sachs.
InvestingPro Insights
As Viridian Therapeutics progresses with its THRIVE-2 trial, financial metrics and market performance provide additional context for investors considering the company’s prospects. According to recent data from InvestingPro, Viridian holds a market cap of approximately $912.66 million, reflecting its position within the biotech industry.
Despite the company’s significant research and development efforts, it currently operates with a negative P/E ratio of -3.27, which further adjusts to -4.19 when considering the last twelve months as of Q1 2024. This indicates that the company is not yet profitable, a status that is aligned with the InvestingPro Tip highlighting analysts’ expectations that Viridian will not achieve profitability this year.
On a more positive note, an InvestingPro Tip points out that Viridian has experienced a significant return over the last week, with a 12.84% price total return, showcasing investor enthusiasm possibly linked to the clinical trial developments.
Moreover, the company’s liquid assets exceed short-term obligations, suggesting a strong liquidity position that may support ongoing clinical trials and operations. However, the company is quickly burning through cash, which is a critical factor for investors to monitor given the substantial costs associated with bringing new treatments to market.
For those interested in a deeper analysis, InvestingPro offers additional tips on Viridian Therapeutics, which can be accessed by visiting: https://www.investing.com/pro/VRDN. Readers can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, unlocking further insights into Viridian’s financial health and market standing. There are 8 additional InvestingPro Tips available that may provide more comprehensive guidance for investors looking at Viridian’s long-term potential.
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