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Belite Bio Completes Global Enrollment in DRAGON II Tinlarebant Trial for Stargardt Disease

Story Highlights
  • Belite Bio has fully enrolled 60 adolescents worldwide in its Phase 2/3 DRAGON II trial of tinlarebant for Stargardt disease.
  • With DRAGON II enrollment complete and strong Phase 3 data, Belite moves toward U.S. and Japanese approvals for tinlarebant in STGD1.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Belite Bio Completes Global Enrollment in DRAGON II Tinlarebant Trial for Stargardt Disease

Meet Samuel – Your Personal Investing Prophet

Belite Bio, Inc. ADR ( (BLTE) ) has shared an announcement.

On January 27, 2026, Belite Bio announced it has completed enrollment of 60 adolescent patients, including 15 in Japan, in its global Phase 2/3 DRAGON II trial of tinlarebant for Stargardt disease type 1, a 24‑month randomized, double‑masked, placebo‑controlled study spanning Japan, the United States and the United Kingdom. The milestone, achieved after tinlarebant previously met the primary endpoint in the pivotal Phase 3 DRAGON trial with a 36% reduction in lesion growth, advances Belite’s registration strategy in both the U.S. and Japan and keeps the company on track to file a U.S. New Drug Application in the first half of 2026, reinforcing its position as a front-runner in developing the first disease-modifying treatment for STGD1 and potentially strengthening its standing in the broader retinal disease market.

The most recent analyst rating on (BLTE) stock is a Buy with a $195.00 price target. To see the full list of analyst forecasts on Belite Bio, Inc. ADR stock, see the BLTE Stock Forecast page.

Spark’s Take on BLTE Stock

According to Spark, TipRanks’ AI Analyst, BLTE is a Neutral.

BLTE’s score is driven by solid balance-sheet strength but weighed down by pre-revenue financials and rising cash burn. Technicals are bullish with strong trend support, while valuation remains challenging due to ongoing losses. The latest earnings call was a net positive on regulatory/clinical progress and improved liquidity, despite higher expenses and losses.

To see Spark’s full report on BLTE stock, click here.

More about Belite Bio, Inc. ADR

Belite Bio, Inc. is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical need, including Stargardt disease type 1 (STGD1) and geographic atrophy in advanced dry age-related macular degeneration, as well as certain metabolic diseases. Its lead oral candidate, tinlarebant, is designed to reduce the accumulation of bisretinoid toxins in the eye by lowering serum retinol binding protein 4, and has received multiple expedited and orphan designations in the U.S., Europe and Japan, while being studied in late-stage global trials such as DRAGON, DRAGON II and PHOENIX.

Average Trading Volume: 224,020

Technical Sentiment Signal: Buy

Current Market Cap: $5.67B

For a thorough assessment of BLTE stock, go to TipRanks’ Stock Analysis page.

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