Janux stock plunges after hours following mCRPC trial data
Investing.com -- Belite Bio Inc ADR (NASDAQ:BLTE) stock jumped 17.1% in premarket trading Monday after announcing positive Phase 3 trial results for Tinlarebant, marking the first successful pivotal trial for Stargardt disease, a progressive vision loss condition with no currently approved treatments.
The company’s DRAGON trial met its primary efficacy endpoint, demonstrating a statistically significant 36% reduction in retinal lesion growth rate compared to placebo (p=0.0033). Stargardt disease affects more than 50,000 patients in the U.S. and has previously had no treatment options.
Tinlarebant was well-tolerated throughout the trial with only four treatment-related discontinuations. The most common drug-related ocular adverse events were xanthopsia and delayed dark adaptation, which were mostly mild and resolved during the trial.
"The final results from the DRAGON trial mark a historic breakthrough in Stargardt disease, paving the way for the first potential treatment for this devastating condition and bringing new hope to patients and families who have long faced a disease once considered untreatable," said Dr. Tom Lin, Chairman and CEO of Belite Bio.
The trial enrolled 104 patients aged 12-20 years with Stargardt disease type 1. In addition to the primary endpoint success, the treatment also showed a 33.6% lesion growth reduction in patients’ fellow eyes (p=0.041) and met key secondary endpoints.
Belite Bio plans to file a New Drug Application with the FDA in the first half of 2026. Tinlarebant has already received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S., along with Orphan Drug Designation in the U.S., Europe, and Japan.
The company will host a conference call today at 8:00 a.m. ET to discuss the results.
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