MHRA

Belite Bio (BLTE) announced that the UK’s MHRA agreed to accept a Conditional Marketing Authorization application for Tinlarebant to treat Stargardt disease, based on Phase 3 DRAGON interim analysis. The DRAGON trial enrolled 104 subjects across 11 jurisdictions. Topline final data is expected in Q4 2025, which will be submitted to MHRA for full Marketing Authorization. This regulatory milestone offers a faster route to market but depends on positive final data.

The UK’s MHRA is accelerating the evaluation of AI tools to revolutionize healthcare, aiming to drastically reduce medical test result waiting times through its ‘AI Airlock’ program. Seven novel AI technologies are being rigorously assessed to address healthcare challenges, potentially speeding up cancer diagnosis and improving detection of genetic eye diseases. The program provides a secure environment for testing, informing the MHRA’s evolving AI regulatory framework and the National Commission into the Regulation of AI in Healthcare. This initiative emphasizes safe and effective AI adoption within the NHS.