Belite Bio, Inc. (D01)
XFRA 
Summary
D01 Chart
Belite Bio Wins FDA Priority Review for Tinlarebant in Stargardt Disease
Belite Bio NASDAQ: BLTE said the U.S. Food and Drug Administration has accepted its new drug application for tinlarebant as a treatment for Stargardt disease type 1, granted the application priority review and set a Feb. 12, 2027, PDUFA date.
Belite Bio, Inc (BLTE) Discusses Prelaunch Strategy and Commercial Opportunity for Tinlarebant in Stargardt Disease Type 1 Transcript
Belite Bio, Inc (BLTE) Discusses Prelaunch Strategy and Commercial Opportunity for Tinlarebant in Stargardt Disease Type 1 Transcript
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.
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Belite Bio, Inc. Profile
| Biotechnology Industry | Healthcare Sector | Yu-Hsin Lin CEO | XFRA Exchange | 07782B104 CUSIP |
| 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.
Contact Information
