BLTE Share Price Performance

US$155.54

94.65 (155.44%)

US$211.50

Fair Value

US$155.54

94.65 (155.44%)

26.5% undervalued

US$211.50

Fair Value

US$155.54

US$211.50

Thu, 5 Mar 26

Fair ValueUS$211.50

Share Pricen/a

BLTE Community Narratives

AnalystConsensusTarget's

Fair Value

Fair Value US$211.5 26.5% undervalued

Oral Retinal Therapy Potential Will Reshape Long Term Outlook For This Pre Revenue Biotech

About BLTE

Founded: 2016
Employees: 41
CEO: Yu-Hsin Lin
WebsiteView website: www.belitebio.com

Belite Bio, Inc, a clinical stage biopharmaceutical drug development company, engages in the research and development of novel therapeutics with unmet medical needs in the United States. Its lead product candidate is Tinlarebant (LBS-008), an orally administered, which is in phase 3 clinical trial as an early intervention for maintaining the health and integrity of retinal tissues in stargardt disease type 1 and geographic atrophy patients. The company also develops LBS-009, an retinol binding protein 4 oral therapy, which is in preclinical development targeting liver disease, including non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, and type 2 diabetes, as well as gout. Belite Bio, Inc was founded in 2016 and is based in San Diego, California. Belite Bio, Inc operates as a subsidiary of Lin Bioscience International Ltd.

Recent BLTE News & Updates

Announcement • Apr 24

Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease

Belite Bio Inc. initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant, an investigational novel oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. Tinlarebant has previously been granted Breakthrough Therapy Designation (BTD) by the FDA for STGD1, and the FDA has previously granted Belite approval for the rolling submission of the NDA. The Company expects to complete the NDA rolling submission in the second quarter of 2026. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1. The Company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with GA.

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Belite Bio, Inc Stock Price

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Oral Retinal Therapy Potential Will Reshape Long Term Outlook For This Pre Revenue Biotech

Oral Retinal Therapy Potential Will Reshape Long Term Outlook For This Pre Revenue Biotech

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Oral Retinal Therapy Potential Will Reshape Long Term Outlook For This Pre Revenue Biotech

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Belite Bio, Inc Key Details

About BLTE

Recent BLTE News & Updates

Belite Bio Advances Tinlarebant in Phase 3 and Raises US$15 Million for Development

Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease

Oral Retinal Therapy Potential Will Reshape Long Term Outlook For This Pre Revenue Biotech

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