Belite Bio (BLTE) announced that United Kingdom’s, U.K., Medicines and Healthcare Products Regulatory Agency, MHRA, has agreed to accept a Conditional Marketing Authorization, CMA, application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial. MHRA’s response is based on the interim analysis results which fulfil the criteria for a Conditional Marketing Authorization application. The Company remains on track to report final topline data from the Phase 3 DRAGON trial in the fourth quarter of 2025. These results are expected to be submitted to the MHRA for full Marketing Authorization Application.
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