Shots:
- The UK’s MHRA has accepted a conditional marketing authorization (CMA) application for Tinlarebant to treat Stargardt disease
- CMA was based on the interim results from P-III (DRAGON) trial assessing Tinlarebant vs PBO in 104 adolescents with Stargardt disease across 11 jurisdictions, incl. the US, UK, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, & Australia
- The company is expected to reveal the final topline data from the DRAGON trial in Q4’25, with plans to submit the data to the MHRA for a full MAA
Ref: Belite Bio | Image: Belite Bio | Press Release
Related News:- Belite Bio Reveals Interim P-III (DRAGON) Trial Data of Tinlarebant for Adolescent Stargardt Disease
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