Belite Bio Starts Rolling Submission of New Drug Application for Eye Treatment

Dow Jones

04/22

By Christopher Kuo

Belite Bio started rolling submission of a New Drug Application to the Food and Drug Administration for its treatment of a rare retinal disorder.

The company on Tuesday said it expects to complete the submission in the second quarter. The NDA is for the company's drug tinlarebant, which is designed to treat Stargardt disease type 1, an inherited retinal disorder caused by genetic mutations that often results in legal blindness.

The company has completed a Phase 3 trial in adolescent STGD1 subjects. Tinlarebant was previously granted Breakthrough Therapy Designation by the FDA, the company said.

Write to Christopher Kuo at chris.kuo@wsj.com

(END) Dow Jones Newswires

April 21, 2026 17:00 ET (21:00 GMT)

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The NDA is for the company's drug tinlarebant, which is designed to treat Stargardt disease type 1, an inherited retinal disorder caused by genetic mutations that often results in legal blindness. \n</p>\n<p>\n  The company has completed a Phase 3 trial in adolescent STGD1 subjects. Tinlarebant was previously granted Breakthrough Therapy Designation by the FDA, the company said. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Christopher Kuo at chris.kuo@wsj.com \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  April 21, 2026 17:00 ET (21:00 GMT)\n</p>\n<p>\n  Copyright (c) 2026 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BLTE","symbol_name":"Belite Bio, Inc.","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2629063583","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2629063583","pubTimestamp":1776805200,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Belite Bio started rolling submission of a New Drug Application to the Food and Drug Administration for its treatment of a rare retinal disorder.The company on Tuesday said it expects to complete the submission in the second quarter. The NDA is for the company's drug tinlarebant, which is designed to treat Stargardt disease type 1, an inherited retinal disorder caused by genetic mutations that often results in legal blindness.The company has completed a Phase 3 trial in adolescent STGD1 subjects. Tinlarebant was previously granted Breakthrough Therapy Designation by the FDA, the company said.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BLTE":"Belite Bio, Inc.","BK4007":"制药"},"translate_title":"贝利特生物开始滚动提交眼科治疗新药申请","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BLTE":0.9},"content_text":"By Christopher Kuo \n\n\n \n\n\nBelite Bio started rolling submission of a New Drug Application to the Food and Drug Administration for its treatment of a rare retinal disorder. \n\n\n  The company on Tuesday said it expects to complete the submission in the second quarter. The NDA is for the company's drug tinlarebant, which is designed to treat Stargardt disease type 1, an inherited retinal disorder caused by genetic mutations that often results in legal blindness. \n\n\n  The company has completed a Phase 3 trial in adolescent STGD1 subjects. Tinlarebant was previously granted Breakthrough Therapy Designation by the FDA, the company said. \n\n\n \n\n\n  Write to Christopher Kuo at chris.kuo@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  April 21, 2026 17:00 ET (21:00 GMT)\n\n\n  Copyright (c) 2026 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":true,"need_login_tip":false,"code":"91000000","status":"200"}}}