Belite Bio (NASDAQ: BLTE) saw a 12% increase in share price after announcing positive results from a phase 3 trial of its drug candidate, tinlarebant, for treating Stargardt disease. The medication showed a 36% reduction in lesion growth compared to a placebo, with minimal change in visual acuity after 24 months.

CEO Tom Lin stated that tinlarebant is the first oral treatment to demonstrate a clinically meaningful outcome in retinal degenerative disease. Belite plans to submit New Drug Applications for the medication in the first half of next year, pending regulatory approval.

Investors reacted positively to the news, anticipating potential FDA approval for tinlarebant. However, it’s important to remember that regulatory approval is not guaranteed even after successful late-stage trials. Belite remains focused on addressing the challenges of Stargardt disease with their innovative treatment approach.

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Read more at Yahoo Finance: Why Belite Bio Stock Soared on Monday