In a report released today, Yi Chen from H.C. Wainwright reiterated a Buy rating on Belite Bio, Inc. ADR (BLTE – Research Report), with a price target of $100.00.
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Yi Chen has given his Buy rating due to a combination of factors related to the promising interim results from Belite Bio’s Phase 3 DRAGON trial for tinlarebant in treating adolescent Stargardt disease. The Data Safety Monitoring Board (DSMB) has recommended the continuation of the trial without modifications, indicating a consistent safety profile and sufficient efficacy observed in the trial thus far.
Additionally, the stabilization of visual acuity in the majority of subjects and the DSMB’s suggestion to submit the data for regulatory review further support the potential for tinlarebant to receive expedited approval. The trial’s design, which includes a robust global, multicenter, randomized, and placebo-controlled approach, adds to the confidence in the study’s outcomes. If the final data aligns with or surpasses the Phase 2 results, tinlarebant could become the first FDA-approved treatment for Stargardt disease, bolstered by its various designations such as Fast Track and Orphan Drug status in multiple regions.