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Belite Bio Advances Tinlarebant Trials with Positive Interim Results

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Belite Bio, Inc. ADR ( (BLTE) ) has issued an update.

On May 13, 2025, Belite Bio, Inc announced its first-quarter financial results and provided a corporate update. The company highlighted the progress of its pivotal Phase 3 DRAGON trial for Tinlarebant in adolescent Stargardt disease patients, which received a positive interim analysis from an independent Data Safety Monitoring Board (DSMB), recommending the trial proceed without modifications. Additionally, the DSMB advised submitting interim data for regulatory review, indicating potential drug approval. The company also reported ongoing enrollment in its global Phase 3 PHOENIX trial for geographic atrophy patients, with 464 of the targeted 500 subjects enrolled. Financially, Belite raised $15 million in a direct offering in February 2025, and reported a net loss of $14.3 million for the first quarter of 2025, attributed to increased research and development expenses.

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, Inc 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). Their lead candidate, Tinlarebant, is an oral therapy aimed at reducing toxic accumulation in the eye and is currently undergoing Phase 3 and Phase 2/3 clinical trials.

Average Trading Volume: 39,098

Technical Sentiment Signal: Strong Buy

Current Market Cap: $1.97B

Learn more about BLTE stock on TipRanks’ Stock Analysis page.

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