Belite Bio Recieves UK Acceptance for Conditional Approval of Stargardt Disease Drug-March 2024-www.financetom.com

Belite Bio Recieves UK Acceptance for Conditional Approval of Stargardt Disease Drug

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Belite Bio Recieves UK Acceptance for Conditional Approval of Stargardt Disease Drug

Nov 3, 2025 1:08 AM

03:30 AM EST, 11/03/2025 (MT Newswires) -- Belite Bio ( BLTE ) said Sunday that the UK's Medicines and Healthcare Products Regulatory Agency has agreed to review a conditional marketing authorization application for its experimental drug Tinlarebant, to treat Stargardt disease.

The company said the decision was based on interim results from an ongoing phase 3 trial.

The company expects to release final phase 3 data in Q4, which will support a full marketing authorization submission to the MHRA.

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