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Belite Bio H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H.C. Wainwright 27th Annual Global Investment Conference summary9 Sep, 2025
Clinical development updates
DRAGON trial for Stargardt disease completed last patient visit; top-line data expected by end of Q4 2024, with NDA submission planned for H1 2026.
Tinlarebant showed prevention and slowed growth of atrophic lesions in phase II, with nearly 50% reduction compared to controls.
Safety profile remains excellent, with withdrawal rate due to ocular adverse events under 4%.
PHOENIX trial in geographic atrophy (GA) fully enrolled; top-line data expected Q3 2027.
DRAGON 2 trial fully enrolled by end of 2024; top-line data expected two years later.
Regulatory and market strategy
FDA granted breakthrough designation for Tinlarebant based on interim analysis; full approval to be sought in US and other major markets.
Regulatory strategy includes broad label submissions in US, Europe, Japan, UK, Switzerland, and Australia.
Japanese approval requires DRAGON 2 trial data due to Sakigake designation and PMDA requirements.
Market focus will be on Stargardt first, leveraging orphan indication pricing and specialist networks.
Market opportunity and competition
Estimated US Stargardt prevalence is 47,000–59,000, with potential market penetration of over 20,000 patients.
Tinlarebant expected to be effective in both adolescent and adult populations, with no age restriction anticipated.
Nanoscope's gene therapy seen as complementary, targeting late-stage vision loss, while Tinlarebant aims to prevent progression.
Tinlarebant's oral administration could make it a first-line therapy for GA if efficacy matches complement inhibitors.
Is one Dragon trial sufficient for US approval?
Tinlarebant as first-line therapy for GA patients?
When do Tinlarebant patents expire?
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Next Belite Bio earnings date
Q3 202511 Nov, 2025
Next Belite Bio earnings date
Q3 202511 Nov, 2025
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Frequently asked questions
Belite Bio, Inc. is a clinical-stage biopharmaceutical company engaged in developing novel therapeutics targeting retinal degenerative eye diseases and certain metabolic diseases. The company's primary focus includes conditions such as atrophic age-related macular degeneration (AMD) and autosomal recessive Stargardt disease type 1 (STGD1), which can lead to permanent blindness. Additionally, Belite Bio is exploring treatments for metabolic disorders like non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), type 2 diabetes (T2D), and gout. Belite Bio, Inc. was founded in 2016 and is headquartered in San Diego, California. The company's shares are listed on the NASDAQ.
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