Outlook Therapeutics Shares Fall After Another FDA Rejection of Macular Degeneration Drug

Dow Jones

01/01

By Katherine Hamilton

Outlook Therapeutics shares slid after the company's macular degeneration drug was once again rejected by the Food and Drug Administration.

The stock dropped 71% to 45 cents a share in after-hours trading. Through the close, shares had lost 16% this year.

The Iselin, N.J., biopharmaceutical company said Wednesday it received notice that the FDA wouldn't approve its biologics license application for ONS-5010/Lytenava, which is designed to treat wet age-related macular degeneration.

Outlook said the FDA was requesting more confirmatory evidence of the drug's efficacy, though it didn't provide details on what kind of evidence it was looking for.

In August, the FDA said it wouldn't approve the drug for similar reasons. Also, in 2023, the FDA turned away Outlook's initial application for ONS-5010, saying it had issues with chemistry, manufacturing and controls.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

December 31, 2025 17:05 ET (22:05 GMT)

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Through the close, shares had lost 16% this year. \n</p>\n<p>\n  The Iselin, N.J., biopharmaceutical company said Wednesday it received notice that the FDA wouldn't approve its biologics license application for ONS-5010/Lytenava, which is designed to treat wet age-related macular degeneration. \n</p>\n<p>\n  Outlook said the FDA was requesting more confirmatory evidence of the drug's efficacy, though it didn't provide details on what kind of evidence it was looking for. \n</p>\n<p>\n  In August, the FDA said it wouldn't approve the drug for similar reasons. Also, in 2023, the FDA turned away Outlook's initial application for ONS-5010, saying it had issues with chemistry, manufacturing and controls. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Katherine Hamilton at katherine.hamilton@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  December 31, 2025 17:05 ET (22:05 GMT)\n</p>\n<p>\n  Copyright (c) 2025 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":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2600704580","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2600704580","pubTimestamp":1767218700,"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":"Outlook Therapeutics shares slid after the company's macular degeneration drug was once again rejected by the Food and Drug Administration.The stock dropped 71% to 45 cents a share in after-hours trading. 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Through the close, shares had lost 16% this year. \n\n\n  The Iselin, N.J., biopharmaceutical company said Wednesday it received notice that the FDA wouldn't approve its biologics license application for ONS-5010/Lytenava, which is designed to treat wet age-related macular degeneration. \n\n\n  Outlook said the FDA was requesting more confirmatory evidence of the drug's efficacy, though it didn't provide details on what kind of evidence it was looking for. \n\n\n  In August, the FDA said it wouldn't approve the drug for similar reasons. Also, in 2023, the FDA turned away Outlook's initial application for ONS-5010, saying it had issues with chemistry, manufacturing and controls. \n\n\n \n\n\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  December 31, 2025 17:05 ET (22:05 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}