{"id":139,"date":"2026-05-29T14:17:13","date_gmt":"2026-05-29T14:17:13","guid":{"rendered":"https:\/\/interstatemovingexpertss.com\/?p=139"},"modified":"2026-05-29T14:17:13","modified_gmt":"2026-05-29T14:17:13","slug":"replimune-to-resubmit-twice-rejected-drug-for-approval-after-fda-shakeup","status":"publish","type":"post","link":"https:\/\/interstatemovingexpertss.com\/?p=139","title":{"rendered":"Replimune to resubmit twice-rejected drug for approval after FDA shakeup"},"content":{"rendered":"<div><div><div><div><p>In this article<\/p><\/div><ul><li><span>REPL<\/span><span><button><\/button><\/span><\/li><\/ul><\/div><div><button><span><span>Follow your favorite stocks<\/span><span>CREATE FREE ACCOUNT<\/span><\/span><\/button><\/div><\/div><div><p><span>Replimune<span><span><button><\/button><\/span><\/span><\/span> plans to resubmit its melanoma drug to the Food and Drug Administration for review after a leadership exodus at the agency, the company said Friday. <\/p><p>Read more <a href=\"https:\/\/interstatemovingexpertss.com\/?p=136\">Trump DOJ \u2018lawfare\u2019 fund temporarily blocked by judge as suit proceeds<\/a><\/p><p>The FDA twice rejected Replimune&#8217;s melanoma treatment under the previous FDA leadership, including former Commissioner Marty Makary, who stepped down earlier this month. Replimune had accused the FDA of wrongfully blocking what some doctors see as a promising new way to treat the skin cancer, while the FDA had said Replimune ignored the agency&#8217;s guidance for conducting its clinical trials.<\/p><p>The bitter fight became a flashpoint for what some in the drug industry saw as mixed messaging from the FDA under Makary&#8217;s leadership. Certain drugmakers criticized the agency over what they saw as reversals of its guidance around clinical trials and approvals for experimental drugs, saying the inconsistency jeopardized future development of treatments.<\/p><p>Replimune said it and the FDA are now aligned on a path forward and the company will resubmit its application in the coming days. Replimune said the FDA has indicated it will treat the application as an urgent matter and will prioritize its review.<\/p><p>Read more <a href=\"https:\/\/interstatemovingexpertss.com\/?p=133\">\u2018Our flavors are on the shelf\u2019: The evolution of Asian grocery beyond the \u2018ethnic aisle\u2019<\/a><\/p><p>&#8220;This constructive dialogue represents an important step forward for the thousands of patients living with advanced melanoma who have progressed on prior anti-PD-1 based therapy and have limited treatment options available to them,&#8221; Replimune said in a statement.<\/p><p>Replimune shares spiked as much as 70% in premarket trading Friday. Replimune had a market value of $386 million as of Thursday&#8217;s close.<\/p><p>Read more <a href=\"https:\/\/interstatemovingexpertss.com\/?p=130\">\u2018You can\u2019t just leave it to the market\u2019: Frontrunner to replace UK PM Starmer calls for \u2018strong public control\u2019 over industry and AI<\/a><\/p><\/div><div><div><div><div><div>\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" alt=\"Watch CNBC's full interview with FDA Commissioner Marty Makary\" class=\"wp-image-138\" height=\"422\" src=\"https:\/\/interstatemovingexpertss.com\/wp-content\/uploads\/2026\/05\/865a1db3c3895ad70ca098b23633bb7d.jpg\" width=\"750\" srcset=\"https:\/\/interstatemovingexpertss.com\/wp-content\/uploads\/2026\/05\/865a1db3c3895ad70ca098b23633bb7d.jpg 750w, https:\/\/interstatemovingexpertss.com\/wp-content\/uploads\/2026\/05\/865a1db3c3895ad70ca098b23633bb7d-300x169.jpg 300w\" sizes=\"auto, (max-width: 750px) 100vw, 750px\" \/><\/figure>\n<span><div><div><span>watch now<\/span><\/div><\/div><\/span><\/div><div><div><span>VIDEO<\/span><span>12:56<\/span><span>12:56<\/span><\/div><div>Watch CNBC&#8217;s full interview with FDA Commissioner Marty Makary<\/div><div>Squawk on the Street<\/div><\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.<\/p>\n","protected":false},"author":1,"featured_media":137,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[],"class_list":["post-139","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-and-science"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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