Outlook Therapeutics Shares Surge After FDA Accepts Resubmitted Wet AMD Application

Dow Jones

06/16

By Anvee Bhutani

Outlook Therapeutics shares climbed Tuesday after the company said the U.S. Food and Drug Administration accepted its resubmitted biologics license application for ONS-5010/LYTENAVA as a treatment for age-related macular degeneration, a condition in which retina damage results in vision loss.

Shares of the biopharmaceutical company were up around 20% at $1.39. The stock has more than quadrupled in the last month.

The FDA classified the resubmission as a class 1 review and set a Prescription Drug User Fee Act, or PDUFA, target action date of July 29.

If approved, the company said Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration. Outlook Therapeutics said it has begun prelaunch activities ahead of the FDA's decision.

Write to Anvee Bhutani at anvee.bhutani@wsj.com

(END) Dow Jones Newswires

June 16, 2026 10:20 ET (14:20 GMT)

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The stock has more than quadrupled in the last month. \n</p>\n<p>\n  The FDA classified the resubmission as a class 1 review and set a Prescription Drug User Fee Act, or PDUFA, target action date of July 29. \n</p>\n<p>\n  If approved, the company said Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration. Outlook Therapeutics said it has begun prelaunch activities ahead of the FDA's decision. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Anvee Bhutani at anvee.bhutani@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  June 16, 2026 10:20 ET (14:20 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":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2643635917","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2643635917","pubTimestamp":1781619600,"columns":[{"name":"行業數據","id":30,"label_key":"dataReport"}],"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":"Outlook Therapeutics shares climbed Tuesday after the company said the U.S. Food and Drug Administration accepted its resubmitted biologics license application for ONS-5010/LYTENAVA as a treatment for age-related macular degeneration, a condition in which retina damage results in vision loss.Shares of the biopharmaceutical company were up around 20% at $1.39. The stock has more than quadrupled in the last month.The FDA classified the resubmission as a class 1 review and set a Prescription Drug User Fee Act, or PDUFA, target action date of July 29.If approved, the company said Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration. Outlook Therapeutics said it has begun prelaunch activities ahead of the FDA's decision.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","OTLK":"Outlook Therapeutics, Inc."},"translate_title":"FDA接受重新提交的湿AMD申请后，Outlook Therapeutics股价飙升","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"OTLK":1.97},"content_text":"By Anvee Bhutani \n\n\n \n\n\n  Outlook Therapeutics shares climbed Tuesday after the company said the U.S. Food and Drug Administration accepted its resubmitted biologics license application for ONS-5010/LYTENAVA as a treatment for age-related macular degeneration, a condition in which retina damage results in vision loss. \n\n\n  Shares of the biopharmaceutical company were up around 20% at $1.39. The stock has more than quadrupled in the last month. \n\n\n  The FDA classified the resubmission as a class 1 review and set a Prescription Drug User Fee Act, or PDUFA, target action date of July 29. \n\n\n  If approved, the company said Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration. Outlook Therapeutics said it has begun prelaunch activities ahead of the FDA's decision. \n\n\n \n\n\n  Write to Anvee Bhutani at anvee.bhutani@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  June 16, 2026 10:20 ET (14:20 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":"2","news_tag":"dataReport","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":true,"need_login_tip":false,"code":"91000000","status":"200"}}}