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SAN DIEGO - China’s National Medical Products Administration (NMPA) has agreed to accept Belite Bio’s (NASDAQ:BLTE) New Drug Application for Tinlarebant with priority review for the treatment of Stargardt disease, the company announced Wednesday. The $2.6 billion market cap company has seen impressive momentum, with its stock up over 34% in the past six months, according to InvestingPro data.
The NMPA’s decision is based on interim analysis results from the Phase 3 DRAGON trial, which showed statistical significance in the primary endpoint. Belite Bio expects to report final topline data from the trial in the fourth quarter of 2025. Analysts remain optimistic about the company’s prospects, with a consensus "Strong Buy" recommendation and a high price target of $110.
Tinlarebant is an oral therapy designed to reduce the accumulation of vitamin A-based toxins called bisretinoids that cause retinal disease in Stargardt disease, a condition with no currently approved treatments.
"Having China NMPA agreed to review the NDA based on interim Phase 3 data is a remarkable milestone for Belite Bio and the Stargardt community," said Dr. Tom Lin, Chairman and CEO of Belite Bio.
The Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled global study evaluating Tinlarebant’s safety and efficacy in adolescent patients with Stargardt disease. The trial enrolled 104 subjects across 11 jurisdictions with a 2:1 randomization ratio of Tinlarebant to placebo.
Tinlarebant has received multiple regulatory designations including Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations in the U.S., as well as Orphan Drug Designation in the U.S., Europe, and Japan.
The information in this article is based on a company press release statement. InvestingPro analysis shows the company maintains a "GOOD" overall financial health score despite being pre-revenue, with liquid assets significantly exceeding short-term obligations. For deeper insights into Belite Bio’s financial health and growth prospects, including 12 additional ProTips and comprehensive valuation metrics, check out the full InvestingPro Research Report.
In other recent news, Belite Bio has completed the last subject visit in its Phase 3 DRAGON clinical trial for Tinlarebant, aimed at treating Stargardt disease type 1 (STGD1). The trial involved 104 adolescent subjects across 11 jurisdictions, with 94 completing the study, and topline data is expected in the fourth quarter of 2025. In a significant financial move, Belite Bio raised $125 million through a private placement, with the potential to raise an additional $150 million through warrant exercises. This transaction was led by RA Capital Management, with participation from several other investment firms. Benchmark has reiterated its Buy rating and maintains an $80 price target on Belite Bio, highlighting the company’s promising clinical programs. Additionally, H.C. Wainwright adjusted its price target for Belite Bio to $98 from $100 while maintaining a Buy rating. These developments underscore the ongoing interest and investment in Belite Bio’s efforts to advance treatments for retinal diseases.
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