Belite Bio

BLTE

時価総額 $57.5億

SAN DIEGO, Oct. 14, 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 Marketing Authorization Application (MAA) submissions to the regulatory authorities in Singapore, the United Kingdom, and Switzerland for tinlarebant in the treatment of Stargardt disease type 1 (STGD1). Tinlarebant is an investigational, once-daily oral therapy for the treatment of STGD1, a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. There are currently no approved treatment options for the disease in Singapore, the United Kingdom, or Switzerland.

SAN DIEGO, Oct. 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 its data will be presented at the Innovate Retina conference being held on October 8, 2026, in New Orleans, Louisiana, and at the American Academy of Ophthalmology (AAO) 2026 being held on October 9-12, 2026, in New Orleans, Louisiana. Innovate Retina Presentation Details Session 1: Inherited Retinal Diseases (IRD) Title: What Is Coming to the Clinics: Tinlarebant for Stargardt Disease Presenter: Paul Bernstein, MD, PhD, Professor of Ophthalmology and Vice-Chair for Clinical and Basic Science Research at the Moran Eye Center, University of Utah Date and Time: October 8, 2026 3:04 – 3:07 p.m.

SAN DIEGO, Sept. 28, 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 Euretina Innovation Spotlight (EIS) being held on September 30, 2026, and Euretina being held on October 1-4, 2026, in Vienna, Austria.

Belite Bio, Inc (BLTE) Presents at Morgan Stanley 24th Annual Global Healthcare Conference Transcript

Belite Bio, Inc. Sponsored ADR (BLTE) reached a significant support level, and could be a good pick for investors from a technical perspective. Recently, BLTE's 50-day simple moving average broke out above its 200-day moving average; this is known as a "golden cross.

SAN DIEGO, Sept. 08, 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 the submission of a New Drug Application (NDA) to the Ministry of Health, Labour, and Welfare (MHLW) in Japan for tinlarebant in Stargardt disease type 1 (STGD1). Tinlarebant is an investigational, once-daily oral therapy for the treatment of STGD1, a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. STGD1 affects an estimated 9,500 people in Japan alone, and there are currently no approved treatment options for the disease.

Belite Bio Inc. (NASDAQ:BLTE) drew a bullish initiation from Canaccord Genuity, which sees significant upside tied to the potential launch of its lead eye-disease drug, tinlarebant.

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, Inc (BLTE) Discusses Prelaunch Strategy and Commercial Opportunity for Tinlarebant in Stargardt Disease Type 1 Transcript

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: