Belite Bio Inc. ADR (D01)
XDUS 
Summary
D01 Chart
Belite Bio Q2 Earnings Call Highlights
Belite Bio NASDAQ: BLTE said the U.S. Food and Drug Administration has accepted its New Drug Application for tinlarebant, an investigational treatment for Stargardt disease, and granted the application priority review. The agency set a Prescription Drug User Fee Act action date of Feb. 12, 2027.
BLTE Stock Rises as FDA Grants Priority Review to Tinlarebant NDA
Belite Bio's tinlarebant wins FDA priority review for Stargardt Disease, with a decision expected in February 2027 after positive phase III data.
Belite Bio: The Oral Route Is The Real Competitive Moat
Belite Bio (BLTE) is positioned for upside with tinlarebant, an oral therapy for Stargardt disease, following a successful Phase 3 DRAGON trial and NDA submission. BLTE's oral systemic approach offers competitive differentiation, enabling bilateral retinal treatment and potentially reducing the burden of frequent intravitreal injections. With $798.6 million in cash and investments, BLTE maintains a robust runway to support commercialization and further clinical development, including the PHOENIX trial in geographic atrophy.
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Belite Bio Inc. ADR Profile
| Biotechnology Industry | Healthcare Sector | Yu-Hsin Lin CEO | XDUS Exchange | US07782B1044 ISIN |
| US Country | 41 Employees | - Last Dividend | - Last Split | - IPO Date |
Overview
Belite Bio, Inc is a clinical stage biopharmaceutical drug development company focused on addressing the challenges of retinal degenerative eye diseases, which currently have unmet medical needs. Founded in 2016 and headquartered in San Diego, California, the company is a subsidiary of Lin Bioscience International Ltd. Belite Bio, Inc's dedication to innovative research and development has positioned it as a promising entity in the healthcare sector, especially in the realm of eye health.
Products and Services
LBS-008 (Tinlarebant)
This leading product candidate from Belite Bio, Inc is a testament to the company's forward-thinking approach to eye health. Tinlarebant is an orally administered tablet designed to be taken once a day. It aims to maintain the health and integrity of retinal tissues, offering hope to patients suffering from autosomal recessive Stargardt disease and geographic atrophy. These conditions previously had limited treatment options, making Tinlarebant a potentially transformative solution.
LBS-009
Underpinning Belite Bio's diversified research pipeline is LBS-009, an innovative therapeutic option that is currently in the preclinical development phase. This anti-retinol binding protein 4 oral therapy is being explored for its potential applications in treating liver diseases such as non-alcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), and type 2 diabetes. With these conditions affecting a significant portion of the global population, LBS-009 represents a meaningful step toward addressing a critical healthcare challenge.
