企業プロフィール
Belite Bio 株価・ニュース・カタリスト
- ティッカー:
- BLTE
- 取引所:
- NASDAQ
- セクター:
- Biopharma
- 所在地:
- United States with global ties
株価パフォーマンス
163.21 USD (+0.25%)
終値
最終更新: 2026年8月17日
5.41B USD
時価総額
株価変動の要因
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.
企業概要
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.
今後のカタリスト
- FDA action on the tinlarebant NDA by the February 12, 2027 PDUFA target date.
最近のニュース
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類似銘柄
事業成熟度、治療領域、カタリスト傾向が近い同業銘柄です。