公司资料

Belite Bio 股价、新闻与催化剂

股票代码:
BLTE
交易所:
NASDAQ
行业:
Biopharma
所在地:
United States with global ties

股票表现

163.21 USD (+0.25%)

收盘价

最后更新: 2026年8月17日

5.41B USD

市值

股价为何变动

As of Aug 17, 2026, BLTE closed up 0.25% at $163.21. No new same-company headline was identified in the current news window.

公司概览

Retinal Degeneration Company

Belite Bio develops therapies for Stargardt disease type 1, geographic atrophy secondary to advanced dry age-related macular degeneration, and selected metabolic disorders. Lead candidate tinlarebant is an oral therapy designed to reduce the accumulation of bisretinoid toxins in the eye.

Tinlarebant Development Program

Tinlarebant has completed the adolescent STGD1 Phase 3 DRAGON trial and continues to be evaluated in DRAGON II, which includes a Japanese Phase 1b component and a global Phase 2/3 study, as well as the Phase 3 PHOENIX study in geographic atrophy. The company is preparing for potential STGD1 commercialization.

Oral Retinoid Modulation Strategy

Tinlarebant is designed to reduce delivery of retinol to the eye and thereby limit formation of toxic bisretinoid byproducts. This mechanism supports development in inherited Stargardt disease and the larger geographic atrophy population.

Regulatory and Geographic Expansion

Belite has initiated a rolling U.S. NDA submission for tinlarebant in STGD1 and received Swissmedic Orphan Drug Status. The inclusion of Japanese patients in DRAGON II is intended to support a potential future NDA in Japan.

Commercial Preparation

With the adolescent Phase 3 program completed and the U.S. submission underway, Belite is moving from clinical development toward launch planning in STGD1. The geographic atrophy program could subsequently expand the addressable market beyond inherited retinal disease.

未来催化剂

  • FDA action on the tinlarebant NDA by the February 12, 2027 PDUFA target date.

近期新闻

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