Positive Outlook for Belite Bio: Promising Phase 3 Results and Increased Approval Probability for Tinlarebant

H.C. Wainwright analyst Yi Chen has reiterated their bullish stance on BLTE stock, giving a Buy rating on November 24.

Yi Chen has given his Buy rating due to a combination of factors surrounding the promising results from Belite Bio’s Phase 3 DRAGON trial for tinlarebant in treating Stargardt disease (STGD1). The trial met its primary efficacy endpoint, demonstrating a significant reduction in retinal lesion growth compared to placebo, which is a strong indicator of the drug’s potential effectiveness. Additionally, tinlarebant showed a favorable safety profile, which further supports its potential for approval.
Furthermore, the drug has received multiple designations such as Breakthrough Therapy and Orphan Drug in the U.S., and regulatory bodies in China and the UK are open to accepting applications based on interim data. This regulatory support, combined with the unmet need for STGD1 therapies, particularly for adult patients, increases the likelihood of tinlarebant’s approval. Yi Chen has raised the probability of approval to 85% and increased the price target for Belite Bio to $185, reflecting the positive outlook for the company’s market value.

In another report released on November 24, Cantor Fitzgerald also initiated coverage with a Buy rating on the stock with a $154.00 price target.