Belite Bio stock maintains Buy rating at H.C. Wainwright on trial progress

Investing.com - H.C. Wainwright has reiterated a Buy rating and $100.00 price target on Belite Bio, Inc, ADR (NASDAQ:BLTE), currently trading at $56.81 with a market cap of $1.85 billion, following the completion of enrollment in a key clinical trial. According to InvestingPro data, analysts maintain a strong buy consensus with price targets ranging from $50 to $110.

The company announced on July 2 that its Phase 3 PHOENIX trial has successfully enrolled 500 subjects across multiple countries including the U.S., the UK, France, Czech Republic, Switzerland, China, Taiwan, and Australia.

The PHOENIX trial is evaluating tinlarebant for geographic atrophy (GA) in a global, multicenter, randomized, double-masked, and placebo-controlled study, with subjects randomized in a 2:1 ratio to receive either tinlarebant or placebo.

The primary efficacy endpoint measures the slowing of DDAF lesion growth rate from baseline to Month 24 compared to placebo, with an interim analysis planned at the study’s midpoint.

H.C. Wainwright noted that tinlarebant differentiates from other GA treatments as a once-daily oral tablet targeting earlier stage dry AMD (NASDAQ:AMD), with PHOENIX trial participants having relatively smaller lesion sizes compared to those in clinical trials of competing treatments SYFOVRE and IZERVAY.

In other recent news, Belite Bio Inc reported a narrower-than-expected loss for the first quarter of 2025, with earnings per share (EPS) at -$0.27, beating the forecasted -$0.37. This positive earnings surprise reflects the company’s strategic financial management despite increased operational expenses. Belite Bio’s 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. The company maintains a strong cash position, with $157.4 million in liquidity, which is projected to support its operations for four years.

Additionally, Belite Bio achieved a significant regulatory milestone as the FDA granted Breakthrough Therapy Designation to its drug candidate, Tinlarebant, for the treatment of Stargardt disease. This designation aims to expedite the development of drugs that show substantial improvement over existing therapies. Analyst firms such as Benchmark and Cantor Fitzgerald have maintained their positive outlook on Belite Bio, with Benchmark reiterating a Buy rating and an $80 price target. Cantor Fitzgerald also reaffirmed its Overweight rating, citing confidence in the company’s commercial and manufacturing preparations for its drug PRGN-2012. These developments underscore Belite Bio’s progress in advancing its clinical trials and strategic plans.

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