Belite Bio’s Tinlarebant Receives FDA Breakthrough Therapy Designation for Stargardt Disease

An update from Belite Bio, Inc. ADR ( (BLTE) ) is now available.

On May 21, 2025, Belite Bio announced that the FDA granted Breakthrough Therapy Designation for their drug Tinlarebant, intended for treating Stargardt disease (STGD1). This designation, based on interim results from the Phase 3 DRAGON trial, highlights Tinlarebant’s potential efficacy and safety. The designation is a significant milestone, as there are currently no approved treatments for STGD1. The ongoing trial is expected to complete by the end of 2025, and the designation is anticipated to expedite Tinlarebant’s development, potentially benefiting patients with this progressive condition.

The most recent analyst rating on (BLTE) stock is a Buy with a $59.00 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.

Belite Bio faces significant financial challenges with no revenue and increasing losses, impacting its overall score. Technical indicators show neutral momentum, and valuation is unattractive with negative earnings. However, the earnings call highlights clinical advancements and financial stability, providing a positive outlook in the long term despite current financial difficulties.

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

More about Belite Bio, Inc. ADR

Belite Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs, such as Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD), as well as specific metabolic diseases. Their lead candidate, Tinlarebant, is an oral therapy aimed at reducing toxin accumulation in the eye and is currently under evaluation in several clinical trials.

Average Trading Volume: 40,129

Technical Sentiment Signal: Buy

Current Market Cap: $2.12B

For an in-depth examination of BLTE stock, go to TipRanks’ Stock Analysis page.