Belite Bio receives orphan drug status in Switzerland for retinal therapy
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Belite Bio Receives Orphan Drug Status for Tinlarebant in Stargardt Disease in Switzerland
May 18, 2026 4:00 PM EDTTinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, having met the primary endpoint, reductions in lesion growth rate, in the pivotal, global Phase 3 DRAGON trial Company recently initiated a rolling submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), which it expects to complete in 2Q 2026 Tinlarebant has previously been granted Breakthrough Therapy, Fast Track and Rare Pediatric Disease Designations in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Pioneer Drug... More
