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BLTE

Belite Bio

BLTE

Market cap $6.89B

171.09 USD

+10.43

6.49%

At close Updated Sep 3, 4:00 PM EDT

Pre-market

After hours

174.00

+2.91

1.7%

1 day

6.49%

5 days

9.15%

1 month

10.53%

3 months

24.67%

6 months

1.91%

Year to date

7.42%

1 year

169.39%

5 years

1,515.58%

10 years

1,515.58%

About: Belite Bio Inc is a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases which have unmet medical need such as Geographic Atrophy (GA), the late atrophic (dry) form of age-related macular degeneration (AMD), and Stargardt disease type 1 (STGD1). In addition to its product candidate (tinlarebant) which is intended for the treatment of GA and STGD1, its drug development pipeline also includes a small molecule, orally administered compound, LBS-009, which is intended for the treatment of metabolic diseases such as non-alcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), type 2 diabetes (T2D), and gout.

Employees: 41

Healthcare Biotechnology

News

Positive

Neutral

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Sentiment 3-Months

Positive 20%

Neutral 80%

Negative 0%

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 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, 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 to Participate in Four Upcoming Investor Conferences

SAN DIEGO, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Company will participate in four upcoming investor conferences. Details of the presentations are as follows:

Belite Bio to Participate in Four Upcoming Investor Conferences

Belite Bio to Host Virtual Commercial Day on September 2, 2026

SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it will host a Virtual Commercial Day on Wednesday, September 2, 2026, from 8:00 – 9:30 a.m. ET.

Belite Bio to Host Virtual Commercial Day on September 2, 2026

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

SAN DIEGO, Aug. 21, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that its data will be presented at the Schweizerische Ophthalmologische Gesellschaft (SOG) Annual Congress being held on August 26-28, 2026, in Lausanne, Switzerland and the 19th Asia-Pacific Vitreo-retina Society (APVRS) Congress being held on August 28-30, 2026, in Gold Coast, Australia.

Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences

Belite Bio, Inc (BLTE) Q2 2026 Earnings Call Transcript

Belite Bio, Inc (BLTE) Q2 2026 Earnings Call Transcript

Belite Bio, Inc (BLTE) Q2 2026 Earnings Call 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.

Belite Bio Q2 Earnings Call Highlights

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

SAN DIEGO, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced its financial results for the second quarter ended June 30, 2026, and provided a business update.

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

Zacks Investment Research

BLTE Stock Rises as FDA Grants Priority Review to Tinlarebant NDA

Belite Bio's tinlarebant wins FDA priority review for Stargardt Disease, with a decision expected in February 2027 after positive phase III data.

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

SAN DIEGO, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the New Drug Application (NDA) for tinlarebant for the treatment of Stargardt Disease Type 1 (STGD1). The FDA has set a Prescription Drug User Fee Act (PDUFA) date of February 12, 2027.

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

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