Belite Bio, Inc
NASDAQ Capital MarketCapital Structure
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in mil. unless spec.Working Capital
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in mil. unless spec.Quarterly Revenue
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in mil. unless spec.Quarterly Earnings Per Share
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in mil. unless spec.Company Description
- CEO
- Yu-Hsin Lin
- Full Time Employees
- 41
- Sector
- Healthcare
- Industry
- Biotechnology
- Address
- 12750 High Bluff Drive San Diego CA United States of America 92130
- IPO Date
- Apr 29, 2022
- CIK
- 0001889109
- Website
- belitebio.com
- Similar Companies
- Business
- 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
Belite Bio Announces Uplisting to the Nasdaq Global Select Market
Belite Bio Announces Multi-Market Submission of Marketing Authorization Applications Via the Access Consortium Pathway for Tinlarebant for the Treatment of Stargardt Disease Type 1
Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences
Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences
Belite Bio, Inc. Sponsored ADR $BLTE Shares Sold by Squarepoint Ops LLC
Belite Bio, Inc (BLTE) Presents at Morgan Stanley 24th Annual Global Healthcare Conference Transcript
Belite Bio, Inc. Sponsored ADR (BLTE)'s Technical Outlook is Bright After Key Golden Cross
Belite Bio Announces Submission of New Drug Application to the Ministry of Health, Labour, and Welfare in Japan under the Sakigake Designation System for Tinlarebant for the Treatment of Stargardt Disease Type 1
Why Is Belite Bio Stock Soaring Friday?
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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