Belite Bio Says Center For Drug Evaluation Of China's NMPA Agrees To Accept NDA With Priority Review For Tinlarebant For Treatment Of Stargardt Disease Based On Interim Analysis Results From Phase 3 DRAGON Trial

Author: Benzinga Newsdesk | October 15, 2025 08:12am

• NMPA's response is based on the Phase 3 DRAGON interim analysis results
• Topline final data expected in Q4 2025

SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ:BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Center for Drug Evaluation of China's National Medical Products Administration ("NMPA") has agreed to accept the New Drug Application (NDA) with priority review for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial.

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