{"id":3798,"date":"2025-05-05T15:47:58","date_gmt":"2025-05-05T12:47:58","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3798"},"modified":"2025-05-05T15:49:36","modified_gmt":"2025-05-05T12:49:36","slug":"capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/ru\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/","title":{"rendered":"Capricor Therapeutics \u043e\u0431\u044a\u044f\u0432\u043b\u044f\u0435\u0442 \u043e \u0437\u0430\u0432\u0435\u0440\u0448\u0435\u043d\u0438\u0438 \u043f\u0440\u043e\u043c\u0435\u0436\u0443\u0442\u043e\u0447\u043d\u043e\u0439 \u043e\u0431\u0437\u043e\u0440\u043d\u043e\u0439 \u0432\u0441\u0442\u0440\u0435\u0447\u0438 \u0441 FDA \u043f\u043e Deramiocel \u0434\u043b\u044f \u043b\u0435\u0447\u0435\u043d\u0438\u044f \u043a\u0430\u0440\u0434\u0438\u043e\u043c\u0438\u043e\u043f\u0430\u0442\u0438\u0438 \u043f\u0440\u0438 \u043c\u044b\u0448\u0435\u0447\u043d\u043e\u0439 \u0434\u0438\u0441\u0442\u0440\u043e\u0444\u0438\u0438 \u0414\u044e\u0448\u0435\u043d\u043d\u0430"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Capricor Therapeutics, \u0431\u0438\u043e\u0442\u0435\u0445\u043d\u043e\u043b\u043e\u0433\u0438\u0447\u0435\u0441\u043a\u0430\u044f \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u044f, \u0440\u0430\u0437\u0440\u0430\u0431\u0430\u0442\u044b\u0432\u0430\u044e\u0449\u0430\u044f \u0442\u0440\u0430\u043d\u0441\u0444\u043e\u0440\u043c\u0438\u0440\u0443\u044e\u0449\u0438\u0435 \u043a\u043b\u0435\u0442\u043e\u0447\u043d\u044b\u0435 \u0438 \u044d\u043a\u0437\u043e\u0441\u043e\u043c\u0430\u043b\u044c\u043d\u044b\u0435 \u0442\u0435\u0440\u0430\u043f\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0435 \u0441\u0440\u0435\u0434\u0441\u0442\u0432\u0430 \u0434\u043b\u044f \u043b\u0435\u0447\u0435\u043d\u0438\u044f \u0440\u0435\u0434\u043a\u0438\u0445 \u0437\u0430\u0431\u043e\u043b\u0435\u0432\u0430\u043d\u0438\u0439, \u0441\u0435\u0433\u043e\u0434\u043d\u044f \u043e\u0431\u044a\u044f\u0432\u0438\u043b\u0430 \u043e \u0437\u0430\u0432\u0435\u0440\u0448\u0435\u043d\u0438\u0438 \u043f\u0440\u043e\u043c\u0435\u0436\u0443\u0442\u043e\u0447\u043d\u043e\u0439 \u043e\u0431\u0437\u043e\u0440\u043d\u043e\u0439 \u0432\u0441\u0442\u0440\u0435\u0447\u0438 \u0441 \u0423\u043f\u0440\u0430\u0432\u043b\u0435\u043d\u0438\u0435\u043c \u043f\u043e \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e \u0437\u0430 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430\u043c\u0438 \u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430\u043c\u0438 \u0421\u0428\u0410 (FDA) \u043f\u043e \u0437\u0430\u044f\u0432\u043a\u0435 \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u0438 \u043d\u0430 \u043f\u043e\u043b\u0443\u0447\u0435\u043d\u0438\u0435 \u043b\u0438\u0446\u0435\u043d\u0437\u0438\u0438 \u043d\u0430 \u0431\u0438\u043e\u043b\u043e\u0433\u0438\u0447\u0435\u0441\u043a\u0438\u0435 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u044b (BLA), \u043d\u0430\u043f\u0440\u0430\u0432\u043b\u0435\u043d\u043d\u043e\u0439 \u043d\u0430 \u043f\u043e\u043b\u043d\u043e\u0435 \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0435 \u0434\u0435\u0440\u0430\u043c\u0438\u043e\u0441\u0435\u043b\u0430, \u044d\u043a\u0441\u043f\u0435\u0440\u0438\u043c\u0435\u043d\u0442\u0430\u043b\u044c\u043d\u043e\u0439 \u043a\u043b\u0435\u0442\u043e\u0447\u043d\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438, \u0432 \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0435 \u043b\u0435\u0447\u0435\u043d\u0438\u044f \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u043e\u0432 \u0441 \u0434\u0438\u0430\u0433\u043d\u043e\u0441\u0442\u0438\u0440\u043e\u0432\u0430\u043d\u043d\u043e\u0439 \u043a\u0430\u0440\u0434\u0438\u043e\u043c\u0438\u043e\u043f\u0430\u0442\u0438\u0435\u0439 \u043f\u0440\u0438 \u043c\u044b\u0448\u0435\u0447\u043d\u043e\u0439 \u0434\u0438\u0441\u0442\u0440\u043e\u0444\u0438\u0438 \u0414\u044e\u0448\u0435\u043d\u043d\u0430 (\u041c\u0414\u0414).<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u041e\u0433\u043b\u0430\u0432\u043b\u0435\u043d\u0438\u0435<\/h2><nav><ul><li><a href=\"#is-deramiocel-fda-approved\">\u041e\u0434\u043e\u0431\u0440\u0435\u043d \u043b\u0438 Deramiocel FDA?<\/a><\/li><li><a href=\"#what-is-deramiocel\">\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 \u0414\u0435\u0440\u0430\u043c\u0438\u043e\u0446\u0435\u043b?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"is-deramiocel-fda-approved\">\u041e\u0434\u043e\u0431\u0440\u0435\u043d \u043b\u0438 Deramiocel FDA?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0412 \u0445\u043e\u0434\u0435 \u0432\u0441\u0442\u0440\u0435\u0447\u0438 FDA \u0437\u0430\u044f\u0432\u0438\u043b, \u0447\u0442\u043e \u041a\u043e\u043c\u0438\u0442\u0435\u0442 \u043f\u043e \u0440\u0430\u0441\u0441\u043c\u043e\u0442\u0440\u0435\u043d\u0438\u044e \u043d\u0435 \u0432\u044b\u044f\u0432\u0438\u043b \u0441\u0443\u0449\u0435\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u0445 \u043d\u0435\u0434\u043e\u0441\u0442\u0430\u0442\u043a\u043e\u0432 \u0438 \u0447\u0442\u043e \u043f\u0430\u043a\u0435\u0442 \u043d\u0430\u0445\u043e\u0434\u0438\u0442\u0441\u044f \u043d\u0430 \u043f\u0443\u0442\u0438 \u043a \u0434\u0430\u0442\u0435 \u0432\u0441\u0442\u0443\u043f\u043b\u0435\u043d\u0438\u044f \u0432 \u0441\u0438\u043b\u0443 \u0417\u0430\u043a\u043e\u043d\u0430 \u043e \u043f\u043b\u0430\u0442\u0435 \u0437\u0430 \u0440\u0435\u0446\u0435\u043f\u0442\u0443\u0440\u043d\u044b\u0435 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u044b (PDUFA) 31 \u0430\u0432\u0433\u0443\u0441\u0442\u0430 2025 \u0433\u043e\u0434\u0430. FDA \u0442\u0430\u043a\u0436\u0435 \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0434\u0438\u043b \u0441\u0432\u043e\u0435 \u043d\u0430\u043c\u0435\u0440\u0435\u043d\u0438\u0435 \u043f\u0440\u043e\u0432\u0435\u0441\u0442\u0438 \u0437\u0430\u0441\u0435\u0434\u0430\u043d\u0438\u0435 \u043a\u043e\u043d\u0441\u0443\u043b\u044c\u0442\u0430\u0442\u0438\u0432\u043d\u043e\u0433\u043e \u043a\u043e\u043c\u0438\u0442\u0435\u0442\u0430, \u0445\u043e\u0442\u044f \u043e\u0444\u0438\u0446\u0438\u0430\u043b\u044c\u043d\u0430\u044f \u0434\u0430\u0442\u0430 \u043f\u043e\u043a\u0430 \u043d\u0435 \u0443\u0441\u0442\u0430\u043d\u043e\u0432\u043b\u0435\u043d\u0430.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-deramiocel\">\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 \u0414\u0435\u0440\u0430\u043c\u0438\u043e\u0446\u0435\u043b?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Deramiocel (CAP-1002) \u0441\u043e\u0441\u0442\u043e\u0438\u0442 \u0438\u0437 \u0430\u043b\u043b\u043e\u0433\u0435\u043d\u043d\u044b\u0445 \u043a\u043b\u0435\u0442\u043e\u043a, \u043f\u043e\u043b\u0443\u0447\u0435\u043d\u043d\u044b\u0445 \u0438\u0437 \u043a\u0430\u0440\u0434\u0438\u043e\u0441\u0444\u0435\u0440\u044b (CDC), \u0440\u0435\u0434\u043a\u043e\u0439 \u043f\u043e\u043f\u0443\u043b\u044f\u0446\u0438\u0438 \u0441\u0435\u0440\u0434\u0435\u0447\u043d\u044b\u0445 \u043a\u043b\u0435\u0442\u043e\u043a, \u043a\u043e\u0442\u043e\u0440\u044b\u0435, \u043a\u0430\u043a \u0431\u044b\u043b\u043e \u043f\u043e\u043a\u0430\u0437\u0430\u043d\u043e \u0432 \u0434\u043e\u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u0438 \u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u0438\u0441\u0441\u043b\u0435\u0434\u043e\u0432\u0430\u043d\u0438\u044f\u0445, \u043e\u043a\u0430\u0437\u044b\u0432\u0430\u044e\u0442 \u043c\u043e\u0449\u043d\u043e\u0435 \u0438\u043c\u043c\u0443\u043d\u043e\u043c\u043e\u0434\u0443\u043b\u0438\u0440\u0443\u044e\u0449\u0435\u0435 \u0438 \u0430\u043d\u0442\u0438\u0444\u0438\u0431\u0440\u043e\u0437\u043d\u043e\u0435 \u0434\u0435\u0439\u0441\u0442\u0432\u0438\u0435, \u0441\u043e\u0445\u0440\u0430\u043d\u044f\u044f \u0444\u0443\u043d\u043a\u0446\u0438\u044e \u0441\u0435\u0440\u0434\u0435\u0447\u043d\u043e\u0439 \u0438 \u0441\u043a\u0435\u043b\u0435\u0442\u043d\u043e\u0439 \u043c\u0443\u0441\u043a\u0443\u043b\u0430\u0442\u0443\u0440\u044b \u043f\u0440\u0438 \u0434\u0438\u0441\u0442\u0440\u043e\u0444\u0438\u043e\u043f\u0430\u0442\u0438\u044f\u0445, \u0442\u0430\u043a\u0438\u0445 \u043a\u0430\u043a \u041c\u0414\u0414. \u2013 \u041f\u043e\u0434\u0440\u043e\u0431\u043d\u0435\u0435: <a href=\"https:\/\/dmdwarrior.com\/ru\/what-is-deramiocel\/\">\u0427\u0442\u043e \u0442\u0430\u043a\u043e\u0435 Deramiocel? \u0427\u0442\u043e \u0434\u0435\u043b\u0430\u0435\u0442 CAP-1002?<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Capricor Therapeutics , a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the Company\u2019s Biologics License Application (BLA) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3800,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[90,86,87,89,85,362,88],"class_list":["post-3798","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-cap-1002","tag-capricor","tag-capricor-therapeutics","tag-cardiomyopathy","tag-deramiocel","tag-dmd-cardiomyopathy","tag-fda"],"subtitle":"\u0423\u043f\u0440\u0430\u0432\u043b\u0435\u043d\u0438\u0435 \u043f\u043e \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044e \u0437\u0430 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430\u043c\u0438 \u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430\u043c\u0438 \u0421\u0428\u0410 (FDA) \u043f\u0440\u043e\u0432\u0435\u043b\u043e \u043f\u0440\u043e\u043c\u0435\u0436\u0443\u0442\u043e\u0447\u043d\u043e\u0435 \u0441\u043e\u0432\u0435\u0449\u0430\u043d\u0438\u0435 \u0441 Capricor Therapeutics, \u0447\u0442\u043e\u0431\u044b \u0434\u043e\u0431\u0438\u0442\u044c\u0441\u044f \u043f\u043e\u043b\u043d\u043e\u0433\u043e \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u044f \u0434\u0435\u0440\u0430\u043c\u0438\u043e\u0441\u0435\u043b\u0430 \u2014 \u044d\u043a\u0441\u043f\u0435\u0440\u0438\u043c\u0435\u043d\u0442\u0430\u043b\u044c\u043d\u043e\u0439 \u043a\u043b\u0435\u0442\u043e\u0447\u043d\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438 \u0434\u043b\u044f \u043f\u0430\u0446\u0438\u0435\u043d\u0442\u043e\u0432 \u0441 \u043a\u0430\u0440\u0434\u0438\u043e\u043c\u0438\u043e\u043f\u0430\u0442\u0438\u0435\u0439 \u043f\u0440\u0438 \u043c\u044b\u0448\u0435\u0447\u043d\u043e\u0439 \u0434\u0438\u0441\u0442\u0440\u043e\u0444\u0438\u0438 \u0414\u044e\u0448\u0435\u043d\u043d\u0430 (\u041c\u0414\u0414).","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/posts\/3798","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/comments?post=3798"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/posts\/3798\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/media\/3800"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/media?parent=3798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/categories?post=3798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ru\/wp-json\/wp\/v2\/tags?post=3798"}],"curies":[{"name":"WP","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}