Belite Bio (ADR) (BLTE)
Develops oral investigational therapies for retinal and metabolic diseases.
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, 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 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, 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 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.
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.
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 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.
Belite Bio: The Oral Route Is The Real Competitive Moat
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.
Belite Bio Conference Highlights Tinlarebant Data and New Hope for Retinal Diseases
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.
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
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.
Belite Bio to Participate in the H.C. Wainwright 6th Annual Ophthalmology Virtual Conference
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 Eyes Priority FDA Review as Tinlarebant Targets Stargardt Disease
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.
Belite Bio to Participate in the Piper Sandler Virtual Ophthalmology Investor Symposium
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.
Belite Bio Announces Oral Presentations at Two Upcoming Medical Conferences
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 Belite data will be presented at the 63rd Annual Symposium of the International Society for Clinical Electrophysiology of Vision (ISCEV) being held on July 6-11, 2026, in Sydney, Australia, and the American Society of Retina Specialists (ASRS) 2026 Annual Meeting being held on July 15-18, 2026, in Montréal, Canada.
Belite Bio, Inc (BLTE) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Belite Bio, Inc (BLTE) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Belite Bio, Inc (BLTE) Q1 2026 Earnings Call Transcript
Belite Bio, Inc (BLTE) Q1 2026 Earnings Call Transcript
Belite Bio Q1 Earnings Call Highlights
Belite Bio NASDAQ: BLTE said it has begun a rolling New Drug Application submission to the U.S. Food and Drug Administration for Tinlarebant in Stargardt disease, while also accelerating preparations for a potential commercial launch.
Belite Bio Reports Unaudited First Quarter 2026 Financial Results and Provides a Corporate Update
SAN DIEGO, May 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 its unaudited financial results for the first quarter ended March 31, 2026, and provided a business update.