Belite Bio stock rating reiterated at Buy by H.C. Wainwright

Investing.com - H.C. Wainwright has reiterated its Buy rating and $98.00 price target on Belite Bio, Inc, ADR (NASDAQ:BLTE) following a regulatory development for the company’s lead drug candidate. The stock, currently trading at $89.07, has shown remarkable strength with a 12.35% gain in the past week, approaching its 52-week high of $90.InvestingPro data reveals strong analyst consensus, with price targets ranging from $80 to $110.

The firm’s decision comes after Belite Bio announced on October 15 that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application with priority review for tinlarebant in treating Stargardt disease (STGD1).

The NMPA’s acceptance was based on interim analysis results from the Phase 3 DRAGON trial, which showed statistical significance in meeting the primary endpoint for the treatment.

Belite Bio remains on schedule to report final topline data from the DRAGON trial in the fourth quarter of 2025, with these results to be submitted to the NMPA as part of the NDA currently under preparation according to Center for Drug Evaluation guidance in China.

The company’s ongoing DRAGON II trial could potentially serve as a confirmatory trial if such a study is requested as part of the U.S. regulatory process for tinlarebant.

In other recent news, Belite Bio has made significant strides in its clinical and financial endeavors. The company’s New Drug Application for Tinlarebant has been accepted by China’s National Medical Products Administration for priority review, based on promising interim results from the Phase 3 DRAGON trial. This trial, focused on treating Stargardt disease, completed its last subject visit, with 94 out of 104 enrolled adolescents finishing the study. Final topline data from this trial is anticipated in the fourth quarter of 2025.

In financial developments, Belite Bio successfully completed a $275 million private investment in public equity (PIPE) transaction, raising $125 million in gross proceeds, with potential for an additional $150 million if warrants are fully exercised. This transaction was led by RA Capital Management and included several other investment firms. H.C. Wainwright adjusted its price target for Belite Bio to $98, down from $100, while maintaining a Buy rating, following the company’s recent trial completion announcement. Benchmark has also reiterated its Buy rating on the stock, reflecting continued confidence in Belite Bio’s potential.

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