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)

应版权方要求，你需要登录查看该内容

免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。

热议股票

{"basename":"/hans","ssrTDKData":{"titleTemplate":"%s - 老虎证券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎证券,老虎证券开户,老虎券商,老虎证券官网,老虎证券app,tigertrade老虎证券,股票,炒股,新加坡股票交易平台,投资,投资理财","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.0a0bd8dc.png","ogUrl":"https://www.itiger.com/hans/news/2629063583"},"companyName":"老虎证券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2629063583\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2629063583?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-04-22 05:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2629063583","market":"other","top_or_hot":-1,"title":"Belite Bio Starts Rolling Submission of New Drug Application for Eye Treatment","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Christopher Kuo \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  <a href=\"https://laohu8.com/S/BLTE\">Belite Bio</a> started rolling submission of a New Drug Application to the Food and Drug Administration for its treatment of a rare retinal disorder. \n</p>\n<p>\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</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>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Belite Bio Starts Rolling Submission of New Drug Application for Eye Treatment</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nBelite Bio Starts Rolling Submission of New Drug Application for Eye Treatment\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Dow Jones </p>\n<p class=\"h-time\">2026-04-22 05:00</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Christopher Kuo \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  <a href=\"https://laohu8.com/S/BLTE\">Belite Bio</a> started rolling submission of a New Drug Application to the Food and Drug Administration for its treatment of a rare retinal disorder. \n</p>\n<p>\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</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\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"}}}