Belite Bio Receives Sakigake (Pioneer Drug) Designation of Tinlarebant for Stargardt Disease in Japan
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Belite Bio, Inc - American Depositary Shares (BLTE)
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Source: GlobeNewswire
Tinlarebant is Belite Bio’s orally administered tablet intended to slow disease progression in patients affected with Stargardt Disease (STGD1) and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD)Data from a 24-month Phase 2 trial in adolescent STGD1 subjects showed a sustained lower atrophic lesion growth in Tinlarebant-treated subjects compared to ProgStar participants possessing similar baseline characteristics (aged =18 years) (pIn the Phase 2 trial, 5 of 12 subjects (42%) with known pathogenic ABCA4 mutations, no incident atrophic (DDAF) lesions were formed during the 24-month treatment period and no change in autofluorescent (QDAF) lesions was observedEnrollment of a pivotal global Phase 3 trial of Tinlarebant in adolescent STGD1 subjects (“DRAGON”) has been completed with interim data expected in 4Q 2024Initiated DRAGON II trial of Tinlarebant in adolescent STGD1 patientsTinlarebant has been granted Orphan Drug Designation in Japan for the trea
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- Belite Bio, Inc (NASDAQ: BLTE) had its "buy" rating re-affirmed by analysts at Benchmark Co.. They now have a $57.00 price target on the stock.MarketBeat
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- 5/13/24 - Beat
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