Belite Bio, Inc
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- Belite Bio, Inc (Nasdaq: BLTE), a clinical-stage biopharmaceutical company, develops novel therapeutics targeting degenerative retinal diseases with significant unmet medical needs, including autosomal recessive Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD), as well as metabolic disorders such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), type 2 diabetes (T2D), and gout. Founded in 2016 and headquartered in San Diego, California, the company operates globally with ongoing clinical trials in the United States, Europe, Japan, China, and the United Kingdom; it functions as a subsidiary of Lin Bioscience International Ltd. Its lead product candidate, Tinlarebant (LBS-008), is an oral, once-daily retinol binding protein 4 (RBP4) antagonist designed to reduce toxic vitamin A byproduct accumulation in the retina, currently advancing in multiple pivotal trials including the completed Phase 3 DRAGON trial (104 adolescent STGD1 patients, final topline data expected Q4 2025), the ongoing Phase 2/3 DRAGON II trial (adolescent STGD1 patients including Japanese subjects), and the enrollment-completed Phase 3 PHOENIX trial (530 GA patients); Tinlarebant has received Orphan Drug Designation in the U.S., Europe, and Japan, Rare Pediatric Disease and Breakthrough Therapy Designations in the U.S., Fast Track Designation in the U.S., and Sakigake Designation in Japan. The company's preclinical pipeline features LBS-009, an oral anti-RBP4 therapy that competes with retinol binding to promote RBP4 elimination via renal filtration, targeting NAFLD, NASH, T2D, and gout in patient populations exceeding 2.4 billion worldwide. Recent developments include China's National Medical Products Administration (NMPA) agreeing to accept a New Drug Application with priority review for Tinlarebant in STGD1 based on DRAGON interim results, the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) agreeing to accept a Conditional Marketing Authorization application for the same indication, completion of enrollment in the PHOENIX trial, closure of a $15 million registered direct offering and $125 million private placement (with up to $165 million more from warrants) to support commercialization and operations, and bolstering cash reserves to $275.6 million as of September 30, 2025.
Company News
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Belite Bio Wins FDA Priority Review for Tinlarebant in Stargardt Disease
Belite Bio, Inc (BLTE) Discusses Prelaunch Strategy and Commercial Opportunity for Tinlarebant in Stargardt Disease Type 1 Transcript
Belite Bio to Participate in Four Upcoming Investor Conferences
Belite Bio to Host Virtual Commercial Day on September 2, 2026
Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences
Belite Bio, Inc (BLTE) Q2 2026 Earnings Call Transcript
Belite Bio Q2 Earnings Call Highlights
Belite Bio Reports Unaudited Second Quarter 2026 Financial Results and Provides a Corporate Update
BLTE Stock Rises as FDA Grants Priority Review to Tinlarebant NDA
Belite Bio Announces U.S. Food and Drug Administration Acceptance and Priority Review of New Drug Application for Tinlarebant for the Treatment of Stargardt Disease Type 1
Belite Bio to Host Webcast on August 13, 2026, to Discuss Second Quarter 2026 Financial Results
Belite Bio: The Oral Route Is The Real Competitive Moat
Belite Bio Conference Highlights Tinlarebant Data and New Hope for Retinal Diseases
Belite Bio Announces Oral Presentation at the ASRS Annual Meeting Featuring Additional Positive Secondary Endpoint Data from the Phase 3 Trial of Tinlarebant in Stargardt Disease Type 1
Belite Bio to Participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference
Belite Bio Eyes Priority FDA Review as Tinlarebant Targets Stargardt Disease
Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor Symposium
Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences