BLTE

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

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.

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.

Belite Bio (BLTE) is positioned for upside with tinlarebant, an oral therapy for Stargardt disease, following a successful Phase 3 DRAGON trial and NDA submission. BLTE's oral systemic approach offers competitive differentiation, enabling bilateral retinal treatment and potentially reducing the burden of frequent intravitreal injections. With $798.6 million in cash and investments, BLTE maintains a robust runway to support commercialization and further clinical development, including the PHOENIX trial in geographic atrophy.

Panelists at the H.C. Wainwright Sixth Annual Ophthalmology Virtual Conference said investigational therapies for inherited retinal disorders could begin to reshape treatment options for Stargardt disease and retinitis pigmentosa, two conditions with limited or no approved treatment choices today.

Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease type 1, having met the primary efficacy endpoint, reduction in lesion growth Presentation to include positive update on secondary endpoints, with quantitative autofluorescence showing a marked divergence between treatment groups New Drug Application to the U.S. Food and Drug Administration for tinlarebant completed SAN DIEGO, July 20, 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 additional, positive secondary endpoint data from its Phase 3 DRAGON trial of tinlarebant in Stargardt disease type 1 (STGD1). The findings, along with previously reported topline data, were delivered in an oral presentation at the American Society of Retina Specialists (ASRS) 2026 Annual Meeting on July 18, 2026, in Montréal, Canada.

SAN DIEGO, July 15, 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 a panel discussion at the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference on Wednesday, July 22, 2026, at 3:00 pm ET.

Belite Bio NASDAQ: BLTE Chief Medical Officer Hendrik Scholl said the company is advancing its lead compound, Tinlarebant, as a potential treatment for Stargardt disease and geographic atrophy secondary to age-related macular degeneration, two severe retinal diseases with overlapping features.

SAN DIEGO, July 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 the Company will participate in a fireside chat at the Piper Sandler Virtual Ophthalmology Investor Symposium on Thursday, July 9, 2026, at 12:30 pm ET.