Belite Bio Inc. (BLTE) announced that the Center for Drug Evaluation of China's National Medical Products Administration or NMPA has agreed to accept the New Drug Application with priority review for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial.
The company said it 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 NMPA as part of the NDA.
Tom Lin, CEO of Belite Bio, said: "This achievement positions Belite Bio to advance Tinlarebant through the final stages of development and, if successful, bring the first treatment to people living with Stargardt disease."
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