Replimune Climbs on Report of Makary's Possible Ouster From FDA

Dow Jones

16小時前

By Dean Seal

Shares of Replimune jumped after The Wall Street Journal reported that President Trump plans to fire Food and Drug Administration Commissioner Marty Makary, citing people familiar with the matter.

The biotech company's shares tumbled last month after the FDA rejected, for the second time, Replimune's application for approval of its advanced melanoma drug. Makary defended the rejection in an interview with CNBC earlier this month.

Replimune's stock rose 20%, to $4.01, on Friday afternoon. Shares are still down 59% since the start of the year.

Regulators initially tossed the application in July, saying there was insufficient evidence that the drug alone could explain the results from the trial cited in the application. Replimune reapplied in October with additional early data from the trial.

Replimune criticized the FDA's second rejection, saying the agency's review was marked by inconsistencies and poor communication.

Write to Dean at dean.seal@wsj.com

(END) Dow Jones Newswires

May 08, 2026 15:26 ET (19:26 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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Makary defended the rejection in an interview with CNBC earlier this month. \n</p>\n<p>\n  Replimune's stock rose 20%, to $4.01, on Friday afternoon. Shares are still down 59% since the start of the year. \n</p>\n<p>\n  Regulators initially tossed the application in July, saying there was insufficient evidence that the drug alone could explain the results from the trial cited in the application. Replimune reapplied in October with additional early data from the trial. \n</p>\n<p>\n  Replimune criticized the FDA's second rejection, saying the agency's review was marked by inconsistencies and poor communication. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Dean at dean.seal@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  May 08, 2026 15:26 ET (19:26 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":"BK4588","symbol_name":"碎股","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2634461988","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2634461988","pubTimestamp":1778268360,"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":"Shares of Replimune jumped after The Wall Street Journal reported that President Trump plans to fire Food and Drug Administration Commissioner Marty Makary, citing people familiar with the matter.The biotech company's shares tumbled last month after the FDA rejected, for the second time, Replimune's application for approval of its advanced melanoma drug. Makary defended the rejection in an interview with CNBC earlier this month.Replimune's stock rose 20%, to $4.01, on Friday afternoon. Shares are still down 59% since the start of the year.Regulators initially tossed the application in July, saying there was insufficient evidence that the drug alone could explain the results from the trial cited in the application. 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Replimune reapplied in October with additional early data from the trial. \n\n\n  Replimune criticized the FDA's second rejection, saying the agency's review was marked by inconsistencies and poor communication. \n\n\n \n\n\n  Write to Dean at dean.seal@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 08, 2026 15:26 ET (19:26 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":null,"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"}}}