Swissmedic grants Belite Bio tinlarebant orphan drug status for Stargardt disease

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  • Belite Bio’s lead candidate tinlarebant received orphan drug status from Swissmedic for Stargardt disease.
  • The designation follows Phase 3 DRAGON data showing a 35.7% reduction in retinal lesion growth versus placebo.
  • The company has started a rolling NDA submission with the FDA, targeting completion in 2Q 2026.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Belite Bio Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605181600PRIMZONEFULLFEED9722417) on May 18, 2026, and is solely responsible for the information contained therein.