Belite Bio, Inc (BLTE)

NCM – Real Time Price. Currency in USD

178.40

+0.82 (0.46%)

At close: Aug 12, 2026, 3:59 PM EDT

178.94

0.00 (0.00%)

After-hours: Aug 12, 2026, 4:10 PM EDT

12.08.2026

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.

11.08.2026

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.

06.08.2026

Belite Bio to Host Webcast on August 13, 2026, to Discuss Second Quarter 2026 Financial Results

SAN DIEGO, Aug. 06, 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 webcast on Thursday, August 13, 2026, at 4:30 p.m. Eastern Time to discuss the Company's financial results and provide a business update for the second quarter ended June 30, 2026.

Videos

No Data

There is no data to display

Press releases

11.08.2026

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, Inc (BLTE)

Get all premium features to the best stock analysis tool

Finranks

Company

Contact us

Follow us

Belite Bio, Inc (BLTE)

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

Videos

No Data

Press releases

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

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

Videos

No Data

Press releases

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

Search stocks

Belite Bio, Inc (BLTE)

Get all premium features to the best stock analysis tool

Finranks

Company

Contact us

Follow us

Belite Bio, Inc (BLTE)

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

Videos

No Data

Press releases

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

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

Videos

No Data

Press releases

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