Positive Buy Rating for Belite Bio, Inc. Driven by Promising Phase 3 DRAGON Trial Results and Regulatory Prospects

Analyst Yi Chen of H.C. Wainwright reiterated a Buy rating on Belite Bio, Inc. ADR (BLTE – Research Report), retaining the price target of $100.00.

Yi Chen has given his Buy rating due to a combination of factors surrounding Belite Bio, Inc.’s recent developments and financial performance. The company reported a net loss of $36.1 million for 2024, which was slightly higher than anticipated. However, the positive interim analysis from the Phase 3 DRAGON trial for tinlarebant in treating adolescent Stargardt disease was a significant factor in the rating. The trial demonstrated promising results, with the Data Safety Monitoring Board recommending the continuation of the study without modifications, indicating sufficient efficacy and safety.
Additionally, the stabilization of visual acuity in most subjects and the potential for tinlarebant to become the first FDA-approved treatment for Stargardt disease further support the Buy rating. The trial’s progress, along with its Fast Track and Orphan Drug designations, enhances the company’s prospects for regulatory approval. The ongoing DRAGON II trial and its potential to facilitate a new drug application in Japan also contribute to the positive outlook for Belite Bio, Inc.