On Thursday, H.C. Wainwright maintained a Buy rating for Belite Bio, Inc (NASDAQ:BLTE) shares, with a steady price target of $60.00. The firm's analyst highlighted the recent advancements in the company's DRAGON II trial for tinlarebant, a drug intended to treat Stargardt disease (STGD1). The first patient was dosed earlier this week at the Tokyo Medical Center. This development follows a successful Phase 1b study that assessed the drug's pharmacokinetics and pharmacodynamics in Japan.
The Phase 2/3 segment of the trial is a significant multi-center study, involving locations in the United States, United Kingdom, and Japan. It is designed as a double-masked, placebo-controlled, randomized study with the goal of determining the efficacy, safety, and tolerability of tinlarebant.
The treatment will be administered orally once daily for a period of 24 months to approximately 60 adolescent participants aged 12 to 20 years. This cohort will include around 10 Japanese subjects to support a future new drug application in Japan.
Tinlarebant has received the Sakigake designation in Japan, which could expedite its approval process for STGD1 treatment. The comprehensive data from the DRAGON trial, which includes 104 subjects, combined with the results from Japanese patients in the DRAGON II trial, may facilitate a regulatory submission in the country.
Belite Bio's management has confirmed that the DRAGON trial is on schedule, with an interim analysis update from the Data Safety Monitoring Board expected in the fourth quarter of 2024.
The analyst from H.C. Wainwright expressed optimism about the potential for Japan to become the first country to approve tinlarebant for STGD1 treatment. This anticipation is based on the current progress and regulatory advantages conferred by the Sakigake designation. The reiteration of the $60 price target reflects confidence in the drug's development trajectory and its market prospects.
In other recent news, Belite Bio has reported significant advancements in its clinical trials for Tinlarebant, a treatment for Stargardt disease and geographic atrophy. The company's second-quarter financial results for 2024 showed a net loss of $9.5 million, slightly higher than expected due to a development milestone payment.
However, the company raised $25 million through a registered direct offering and reported research and development expenses of $9.1 million, with cash reserves standing at $112 million.
H.C. Wainwright has adjusted its stock price target for Belite Bio to $60.00, up from the previous $59.00, while maintaining a Buy rating on the stock. The firm's estimated market value for Belite Bio is $1.84 billion, translating to approximately $60 per share. These are recent developments in the company's ongoing efforts to advance its drug pipeline and maintain financial stability.
InvestingPro Insights
As Belite Bio, Inc (NASDAQ:BLTE) advances its DRAGON II trial for tinlarebant, it's important for investors to consider both the company's clinical progress and its financial health. According to the latest InvestingPro data, Belite Bio has a market capitalization of $1.49 billion and is currently trading near its 52-week high, with a price 96.11% of that peak. The company's Price / Book ratio stands at 13.01, indicating a high valuation relative to its book value.
InvestingPro Tips highlight some key considerations: Belite Bio's stock has shown a high return over the last year, with a 61.23% price total return, reflecting strong investor optimism. However, analysts have concerns about the company's profitability, noting that it has not been profitable over the last twelve months and that they do not expect it to be profitable this year. Despite these challenges, Belite Bio's liquid assets exceed its short-term obligations, suggesting financial stability in the near term.
For those interested in a deeper analysis, InvestingPro offers additional tips that can provide further insight into Belite Bio's performance and potential investment opportunities. Visit https://www.investing.com/pro/BLTE to explore these resources.
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