{"id":110306,"date":"2023-08-04T08:14:14","date_gmt":"2023-08-04T06:14:14","guid":{"rendered":"https:\/\/investmentbell.com\/?p=110306"},"modified":"2023-08-04T08:27:34","modified_gmt":"2023-08-04T06:27:34","slug":"mesoblast-shares-tank-after-us-fda-rejects-cell-therapy-for-children","status":"publish","type":"post","link":"https:\/\/investmentbell.com\/fa\/news\/stocks\/mesoblast-shares-tank-after-us-fda-rejects-cell-therapy-for-children\/","title":{"rendered":"Mesoblast shares tank after US FDA rejects cell therapy for children"},"content":{"rendered":"<p>(Reuters) -The U.S. health regulator rejected Mesoblast (NASDAQ:MESO)&#8217;s cell therapy for children under 12 years of age for treating a type of complication that occurs after a stem cell or bone marrow transplant, sending its Australia-listed shares crashing about 58% on Friday.<\/p>\n\n\n\n<p>The U.S. Food and Drug Administration (FDA) required more data to support marketing approval for the company&#8217;s lead product remestemcel-L, Mesoblast said in a statement on Thursday.<\/p>\n\n\n\n<p>Mesoblast shares slumped as much as 58.3% when they opened in Sydney, before marginally paring some losses to trade down 54.8% at A$0.49 by 0416 GMT.<\/p>\n\n\n\n<p>The rejection is a blow to Mesoblast&#8217;s hopes for a potential launch of the therapy, especially after its fundraising efforts over the last two years.<\/p>\n\n\n\n<p>The drug developer was seeking the FDA&#8217;s approval for a cell therapy to treat children with a type of graft versus host disease (GvHD), whose symptoms did not respond to standard steroid therapy or developed recurrence while continuing treatment.<\/p>\n\n\n\n<p>There are no approved therapies in children for the condition in which the donor&#8217;s bone marrow or stem cells attack the recipient.<\/p>\n<div class=\"rate-now\"><span id=\"rate-mypost110306\"><\/span> <span id=\"rate-points\"> 0<\/span><\/div>\n\t\t\t<script type=\"text\/javascript\">jQuery('#rate-mypost110306').raty({\n\t\t\t\thalfShow : true,\n\t\t\t\thalf: true,readOnly: true,score: 0,\n\t\t\t\tpath: \"https:\/\/investmentbell.com\/wp-content\/plugins\/userpro-rating\/images\/\"\n\t\t\t\t});<\/script>","protected":false},"excerpt":{"rendered":"<p>(Reuters) -The U.S. health regulator rejected Mesoblast (NASDAQ:MESO)&#8217;s cell therapy for children under 12 years of age for treating a type of complication that occurs after a stem cell or bone marrow transplant, sending its Australia-listed shares crashing about 58% on Friday. The U.S. Food and Drug Administration (FDA) required more data to support marketing [&hellip;]<\/p>","protected":false},"author":13,"featured_media":110311,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[],"class_list":{"0":"post-110306","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-stocks"},"_links":{"self":[{"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/posts\/110306","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/comments?post=110306"}],"version-history":[{"count":0,"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/posts\/110306\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/media\/110311"}],"wp:attachment":[{"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/media?parent=110306"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/categories?post=110306"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/investmentbell.com\/fa\/wp-json\/wp\/v2\/tags?post=110306"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}