On Tuesday, BTIG maintained a Buy rating for Viridian Therapeutics (NASDAQ:VRDN) with a steady stock price target of $46.00. The firm's focus was on the upcoming pivotal development of VRDN-003, a subcutaneous treatment for thyroid eye disease (TED). The treatment is set to undergo two critical trials, REVEAL-1 and REVEAL-2, with initiation slated for August 2024.
Viridian Therapeutics has revealed its strategy for conducting these trials, which will test two dosing regimens: every four weeks (Q4W) and every eight weeks (Q8W). The company aims to enhance patient convenience and offer cost benefits to payors through the potential for self-administration. REVEAL-1 is targeting an enrollment of 84 patients with active TED, and REVEAL-2 is looking to enroll 126 patients with the chronic condition.
Each trial will randomize patients in a 1:1:1 ratio to receive either the Q4W or Q8W dosage of SC VRDN-003, or a placebo. The regimen begins with a 600mg loading dose, administered as two 300mg injections, followed by subsequent 300mg injections at their respective four or eight-week intervals.
The primary measure of efficacy will be the rate of proptosis improvement (≥2mm) at the 24-week mark, with an extended 28-week follow-up post-treatment. Non-responders will have the option to join an open-label extension (OLE) study.
Secondary outcomes include the degree of proptosis change from the baseline, clinical activity score (CAS), and the presence of double vision (diplopia). Viridian anticipates topline data from both trials in the first half of 2026, which is expected to support a Biologics License Application (BLA) filing by the end of 2026.
In other recent news, Viridian Therapeutics has made significant strides in its clinical programs. The biopharmaceutical company's Phase 3 trial of VRDN-001 for active thyroid eye disease (TED) has completed enrollment, with results anticipated in September 2024.
The company also plans to file a Biologics License Application (BLA) for the same in the latter half of 2025. In addition, Viridian reported progress with its subcutaneous VRDN-003 program following a positive Type C meeting with the FDA.
Wolfe Research initiated coverage on Viridian shares with an Outperform rating, projecting substantial revenue generation by the lead drug candidate, VRDN-001, by 2027. The firm also expects Viridian to reach free cash flow positivity by 2028. Meanwhile, Goldman Sachs (NYSE:GS) has also initiated coverage on Viridian with a Buy rating, emphasizing the potential of VRDN-001 and VRDN-003.
These recent developments highlight the growing confidence in Viridian's financial trajectory and the potential therapeutic impact of its lead drug candidates. As the company continues to make progress in its clinical programs, investor focus is likely to remain on the milestones and financial performance outlined by these research firms.
InvestingPro Insights
As Viridian Therapeutics (NASDAQ:VRDN) gears up for its pivotal trials, the company's financials and market performance provide a mixed backdrop. With a market capitalization of $811.82 million, VRDN is navigating through a challenging phase with a negative P/E ratio of -2.83, reflecting investor concerns over profitability. The company's revenue has seen a significant decline, dropping by 82.59% over the last twelve months as of Q1 2024. This is further compounded by a gross profit margin of -51972.57%, indicating substantial costs relative to its revenue.
On the positive side, an InvestingPro Tip points out that VRDN holds more cash than debt, which could provide some financial flexibility in the near term. Moreover, liquid assets exceed short-term obligations, offering a cushion for the company's operational needs.
Still, analysts are cautious, as evidenced by a consensus that the company will not be profitable this year, and the price has experienced a considerable decline of 37.94% over the last three months. With six analysts revising their earnings upwards for the upcoming period, there may be some optimism about the company's future prospects.
Investors interested in a deeper analysis can find additional InvestingPro Tips for VRDN, which could offer further insights into the company's financial health and market expectations. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and access the full suite of tips and metrics that InvestingPro has to offer.
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