SymbolBLTE
NameBELITE BIO, INC
SectorHEALTH CARE
RegionNorth America
IndustryBiotechnology: Pharmaceutical Preparations
Address5820 OBERLIN DRIVE,SUITE 101, SAN DIEGO, California, 92121, United States
Telephone+1 858 246-6240
Fax
Email
Websitehttps://www.belitebio.com
IncorporationUNDEFINED
Incorporated On
Employees
Fiscal Year
Public Since
ExchangesNASDAQ
Auditor
Audit StatusNOT PROVIDED
Reporting Status
CIK0001889109
Description

Belite Bio Inc is a clinical-stage biopharmaceutical drug development company focused on novel therapeutics targeting untreatable eye diseases involving retinal degeneration such as atrophic age-related macular degeneration and autosomal recessive Stargardt disease or STGD1, both of which progressively lead to permanent blindness, and metabolic diseases such as non-alcoholic fatty liver disease, or NAFLD, nonalcoholic steatohepatitis, or NASH, type 2 diabetes, or T2D, and gout.

Additional info from NASDAQ:
Belite Bio Inc is a clinical-stage biopharmaceutical drug development company focused on novel therapeutics targeting untreatable eye diseases involving retinal degeneration such as atrophic age-related macular degeneration and autosomal recessive Stargardt disease or STGD1, both of which progressively lead to permanent blindness, and metabolic diseases such as non-alcoholic fatty liver disease, or NAFLD, nonalcoholic steatohepatitis, or NASH, type 2 diabetes, or T2D, and gout.

2026-07-20 12:00

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

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2026-07-06 12:00

Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor Symposium

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2026-07-06 11:00

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

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2026-06-22 10:05

Scholl Hendrik Peter 🔴 sold 10.0K shares of BELITE BIO, INC (BLTE) at $147.11 ($1.5M) Transaction Date: Jun 18, 2026 | Filing ID: 276615

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2026-06-17 10:03

Scholl Hendrik Peter 🔴 sold 10.0K shares of BELITE BIO, INC (BLTE) at $145.02 ($1.4M) Transaction Date: Jun 16, 2026 | Filing ID: 273321

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2026-06-16 23:10

📋 Dr. Hendrick P. Scholl (Affiliate) plans to sell 10K shares of Belite Bio, Inc. (at $144.24 each, total $1.4M) Filed: Jun 16, 2026 | ID: 000623

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2026-06-13 01:30

Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1

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2026-05-20 10:00

Belite Bio Reports Unaudited First Quarter 2026 Financial Results and Provides a Corporate Update

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2026-05-18 20:00

Belite Bio Receives Orphan Drug Status for Tinlarebant in Stargardt Disease in Switzerland

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2026-05-14 17:00

New Form SCHEDULE 13G/A - BELITE BIO, INC <b>Filed:</b> 2026-05-14 <b>AccNo:</b> 0001193125-26-223925 <b>Size:</b> 7 KB

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Trial ID Title Phase Indication Status Start Date Completion Date Source
NCT06388083 A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subject… Phase2 STGD1 Active_Not_Recruiting 2024-07-31 2028-02-01 ClinicalTrials.gov
NCT05949593 Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety … Phase3 Geographic Atrophy Active_Not_Recruiting 2023-07-27 2027-08-31 ClinicalTrials.gov
NCT05667688 Pharmacokinetics and Pharmacodynamics Study of LBS-008 in Healthy Volunteers Ag… Phase1 Healthy Volunteer Completed 2022-11-28 2023-01-18 ClinicalTrials.gov
NCT05244304 Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety … Phase3 Stargardt Disease 1 Completed 2022-03-28 2025-09-11 ClinicalTrials.gov
NCT05266014 This is a Dose-finding Study Followed by 2-year Extension Study to Evaluate Saf… Phase1 Stargardt Disease Completed 2021-03-12 2023-08-15 ClinicalTrials.gov
NCT04005807 Safety and Tolerability of Escalating Doses of BPN-14967 in Healthy Adults Phase1 Healthy Volunteers Completed 2019-07-19 2019-12-20 ClinicalTrials.gov
NCT03735810 Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single… Phase1 Healthy Volunteer Completed 2018-11-15 2019-09-16 ClinicalTrials.gov
Total clinical trials: 7
Product Name Type Development Stage Therapeutic Area Study Status Trial ID
Placebo Other Phase PHASE3 Stargardt Disease 1 COMPLETED NCT05244304
Tinlarebant Other Phase PHASE3 Stargardt Disease 1 COMPLETED NCT05244304
Placebo Other Phase PHASE3 Stargardt Disease 1 COMPLETED NCT05244304
Tinlarebant Other Phase PHASE3 Stargardt Disease 1 COMPLETED NCT05244304
Placebos Other Phase PHASE1 Healthy Volunteer COMPLETED NCT03735810
LBS-008 Other Phase PHASE1 Healthy Volunteer COMPLETED NCT03735810
Placebo Other Phase PHASE1 Healthy Volunteers COMPLETED NCT04005807
BPN-14967 Other Phase PHASE1 Healthy Volunteers COMPLETED NCT04005807
Tinlarebant (LBS-008) Other Phase PHASE1 Healthy Volunteer COMPLETED NCT05667688
tinlarebant Other Phase PHASE1 Stargardt Disease COMPLETED NCT05266014
Placebo Other Phase PHASE3 Geographic Atrophy ACTIVE_NOT_RECRUITING NCT05949593
Tinlarebant Other Phase PHASE3 Geographic Atrophy ACTIVE_NOT_RECRUITING NCT05949593
Placebo Other Phase PHASE2 STGD1 ACTIVE_NOT_RECRUITING NCT06388083
Tinlarebant Other Phase PHASE2 STGD1 ACTIVE_NOT_RECRUITING NCT06388083
Tinlarebant (LBS-008) DRUG Phase PHASE1 Healthy Volunteer COMPLETED NCT05667688
tinlarebant DRUG Phase PHASE1 Stargardt Disease COMPLETED NCT05266014
Tinlarebant DRUG Phase PHASE2 STGD1 ACTIVE_NOT_RECRUITING NCT06388083
Placebo DRUG Phase PHASE2 STGD1 ACTIVE_NOT_RECRUITING NCT06388083
BPN-14967 DRUG Phase PHASE1 Healthy Volunteers COMPLETED NCT04005807
Placebos DRUG Phase PHASE1 Healthy Volunteer COMPLETED NCT03735810
LBS-008 DRUG Phase PHASE1 Healthy Volunteer COMPLETED NCT03735810
Total products: 21