Belite Bio Completes Enrollment in DRAGON II Trial for Stargardt Disease
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1d ago
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Source: NASDAQ.COM
- Trial Enrollment Completion: Belite Bio has completed enrollment of 60 subjects in its DRAGON II clinical trial, including 15 Japanese participants, marking a significant milestone in the treatment of Stargardt disease.
- NDA Filing Plans: The company plans to file a New Drug Application (NDA) with the FDA in the first half of 2026, paving the way for the market introduction of tinlarebant and enhancing its influence in the rare eye disease sector.
- Efficacy Validation: Tinlarebant achieved a 36% reduction in lesion growth in the pivotal Phase 3 DRAGON trial, becoming the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, thereby strengthening its competitive position in the market.
- Multiple Designations Granted: Tinlarebant has received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations in the U.S., as well as Orphan Drug Designation in the U.S., Europe, and Japan, highlighting its global market potential and the company's commitment to this drug.
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Analyst Views on BLTE
Wall Street analysts forecast BLTE stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BLTE is 170.86 USD with a low forecast of 85.00 USD and a high forecast of 200.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 165.640
Low
85.00
Averages
170.86
High
200.00
Current: 165.640
Low
85.00
Averages
170.86
High
200.00
About BLTE
Belite Bio, Inc is a clinical-stage biopharmaceutical drug development company. The Company is focused on advancing novel therapeutics targeting retinal degenerative eye disease, such as Geographic Atrophy (GA), age-related macular degeneration (AMD), and Stargardt disease type 1 (STGD1), both of which progressively lead to permanent blindness, and metabolic diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), type 2 diabetes (T2D), and gout. Its lead product candidate, Tinlarebant, is an oral daily treatment for STGD1 and GA patients. In STGD1, it is developing Tinlarebant as a once-a-day tablet treatment to target Retinol binding protein 4 (RBP4) by disrupting vitamin A (retinol) binding to RBP4, which leads to reduced delivery of retinol to the eye and reduced accumulation of toxic vitamin A by-products. Its product candidate also includes LBS-009, an anti-RBP4 oral therapy targeting liver disease, including NAFLD, NASH, and T2D.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Belite Bio Completes Enrollment in DRAGON II Trial for Stargardt Disease
- Trial Enrollment Completion: Belite Bio has completed enrollment of 60 subjects in its DRAGON II clinical trial, including 15 Japanese participants, marking a significant milestone in the treatment of Stargardt disease.
- NDA Filing Plans: The company plans to file a New Drug Application (NDA) with the FDA in the first half of 2026, paving the way for the market introduction of tinlarebant and enhancing its influence in the rare eye disease sector.
- Efficacy Validation: Tinlarebant achieved a 36% reduction in lesion growth in the pivotal Phase 3 DRAGON trial, becoming the first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease, thereby strengthening its competitive position in the market.
- Multiple Designations Granted: Tinlarebant has received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations in the U.S., as well as Orphan Drug Designation in the U.S., Europe, and Japan, highlighting its global market potential and the company's commitment to this drug.
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