Belite Bio stock holds $80 target on FDA breakthrough nod

Published 22/05/2025, 14:32
Belite Bio stock holds $80 target on FDA breakthrough nod

On Thursday, Belite Bio, Inc. (NASDAQ:BLTE), a $2.17 billion market cap biotech company trading at $67.29, maintained its positive outlook from Benchmark analysts, who reiterated a Buy rating and an $80.00 price target on the company’s stock. The reaffirmation comes after Belite Bio announced a significant regulatory milestone. According to InvestingPro data, analyst price targets for BLTE range from $50 to $110, reflecting strong market confidence in the company’s potential. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the company’s drug candidate, Tinlarebant, for the treatment of Stargardt disease (STGD1), a currently untreatable genetic eye disorder.

The FDA’s decision was influenced by promising interim results from Belite Bio’s ongoing Phase 3 DRAGON trial. While the company posted a loss of $1.37 per share over the last twelve months, analysts believe this designation de-risks the clinical development program of Tinlarebant. InvestingPro analysis shows the company maintains strong financial flexibility with a current ratio of 25.98x, suggesting ample resources to fund its clinical programs. Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions when preliminary clinical evidence indicates substantial improvement over existing therapies.

Looking ahead, Belite Bio is preparing for the enrollment of the DRAGON II study, which is expected to take place in the third quarter of the year. Additionally, the completion of the DRAGON study is anticipated by the end of 2025. These milestones are viewed as the next major catalysts for the company’s shares.

In the near term, Belite Bio will be participating in the 5th Annual Benchmark Virtual Healthcare Investor Conference on May 29. The event will provide an opportunity for investors to gain further insights into the company’s progress and future plans. Interested parties are encouraged to contact their Benchmark account executive for more details about the conference. For comprehensive analysis of BLTE’s financial health, valuation metrics, and growth prospects, investors can access the detailed Pro Research Report available on InvestingPro, which covers over 1,400 US stocks with expert insights and actionable intelligence.

In other recent news, Belite Bio Inc ADR reported its earnings for the first quarter of 2025, showing a narrower-than-expected loss. The company’s earnings per share (EPS) came in at -$0.27, beating the forecasted -$0.37, despite increased operating expenses driven by research and development (R&D) and general and administrative (G&A) costs. R&D expenses rose to $9.4 million from $6.8 million year-over-year, while G&A expenses increased to $6.1 million from $1.6 million. Belite Bio maintains a strong cash position with $157.4 million in liquidity, ensuring a four-year cash runway. In other developments, Benchmark analyst Bruce D. Jackson reaffirmed a Buy rating on Belite Bio with a price target of $80. The company’s Phase 3 DRAGON trial received a positive interim analysis, with the Data Safety Monitoring Board recommending accelerated approval. Cantor Fitzgerald also reiterated its Overweight rating on Belite Bio, focusing on the development of PRGN-2012 for Recurrent Respiratory Papillomatosis. The company is making strides in commercial and manufacturing preparations for the potential market launch of PRGN-2012.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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