{"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\/ar\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/","title":{"rendered":"\u0623\u0639\u0644\u0646\u062a \u0634\u0631\u0643\u0629 Capricor Therapeutics \u0639\u0646 \u0627\u0646\u062a\u0647\u0627\u0621 \u0627\u062c\u062a\u0645\u0627\u0639 \u0645\u0631\u0627\u062c\u0639\u0629 \u0645\u0646\u062a\u0635\u0641 \u0627\u0644\u062f\u0648\u0631\u0629 \u0645\u0639 \u0634\u0631\u0643\u0629 FDA \u0628\u0634\u0623\u0646 \u0627\u0633\u062a\u062e\u062f\u0627\u0645 Deramiocel \u0644\u0639\u0644\u0627\u062c \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0627\u0644\u062f\u0648\u0634\u064a\u0646\u064a \u0648\u0627\u0639\u062a\u0644\u0627\u0644 \u0639\u0636\u0644\u0629 \u0627\u0644\u0642\u0644\u0628"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u0623\u0639\u0644\u0646\u062a \u0627\u0644\u064a\u0648\u0645 \u0634\u0631\u0643\u0629 Capricor Therapeutics\u060c \u0648\u0647\u064a \u0634\u0631\u0643\u0629 \u062a\u0643\u0646\u0648\u0644\u0648\u062c\u064a\u0627 \u062d\u064a\u0648\u064a\u0629 \u062a\u0639\u0645\u0644 \u0639\u0644\u0649 \u062a\u0637\u0648\u064a\u0631 \u0639\u0644\u0627\u062c\u0627\u062a \u062a\u0639\u062a\u0645\u062f \u0639\u0644\u0649 \u0627\u0644\u062e\u0644\u0627\u064a\u0627 \u0627\u0644\u062a\u062d\u0648\u064a\u0644\u064a\u0629 \u0648\u0627\u0644\u0625\u0643\u0633\u0648\u0633\u0648\u0645\u0627\u062a \u0644\u0639\u0644\u0627\u062c \u0627\u0644\u0623\u0645\u0631\u0627\u0636 \u0627\u0644\u0646\u0627\u062f\u0631\u0629\u060c \u0639\u0646 \u0627\u0633\u062a\u0643\u0645\u0627\u0644 \u0627\u062c\u062a\u0645\u0627\u0639 \u0645\u0631\u0627\u062c\u0639\u0629 \u0645\u0646\u062a\u0635\u0641 \u0627\u0644\u062f\u0648\u0631\u0629 \u0645\u0639 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 (FDA) \u0644\u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u0644\u0644\u0634\u0631\u0643\u0629 (BLA) \u0627\u0644\u0630\u064a \u064a\u0633\u0639\u0649 \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0645\u0648\u0627\u0641\u0642\u0629 \u0643\u0627\u0645\u0644\u0629 \u0639\u0644\u0649 deramiocel\u060c \u0648\u0647\u0648 \u0639\u0644\u0627\u062c \u062e\u0644\u0648\u064a \u062a\u062c\u0631\u064a\u0628\u064a\u060c \u0643\u0639\u0644\u0627\u062c \u0644\u0644\u0645\u0631\u0636\u0649 \u0627\u0644\u0630\u064a\u0646 \u062a\u0645 \u062a\u0634\u062e\u064a\u0635 \u0625\u0635\u0627\u0628\u062a\u0647\u0645 \u0628\u0627\u0639\u062a\u0644\u0627\u0644 \u0639\u0636\u0644\u0629 \u0627\u0644\u0642\u0644\u0628 \u0627\u0644\u062f\u0648\u0634\u064a\u0646\u064a \u0627\u0644\u0639\u0636\u0644\u064a (DMD).<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u062c\u062f\u0648\u0644 \u0627\u0644\u0645\u062d\u062a\u0648\u064a\u0627\u062a<\/h2><nav><ul><li><a href=\"#is-deramiocel-fda-approved\">\u0647\u0644 \u062a\u0645\u062a \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0639\u0644\u0649 Deramiocel FDA\u061f<\/a><\/li><li><a href=\"#what-is-deramiocel\">\u0645\u0627 \u0647\u0648 \u062f\u064a\u0631\u0627\u0645\u064a\u0648\u0633\u064a\u0644\u061f<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"is-deramiocel-fda-approved\">\u0647\u0644 \u062a\u0645\u062a \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0639\u0644\u0649 Deramiocel FDA\u061f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u062e\u0644\u0627\u0644 \u0627\u0644\u0627\u062c\u062a\u0645\u0627\u0639\u060c \u0635\u0631\u062d\u062a \u0627\u0644\u0644\u062c\u0646\u0629 \u0627\u0644\u0627\u0633\u062a\u0634\u0627\u0631\u064a\u0629 FDA \u0628\u0623\u0646\u0647 \u0644\u0645 \u064a\u062a\u0645 \u062a\u062d\u062f\u064a\u062f \u0623\u064a \u0639\u064a\u0648\u0628 \u062c\u0648\u0647\u0631\u064a\u0629 \u0645\u0646 \u0642\u0628\u0644 \u0644\u062c\u0646\u0629 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0648\u0623\u0646 \u0627\u0644\u062d\u0632\u0645\u0629 \u062a\u0633\u064a\u0631 \u0639\u0644\u0649 \u0627\u0644\u0637\u0631\u064a\u0642 \u0627\u0644\u0635\u062d\u064a\u062d \u0644\u062a\u0627\u0631\u064a\u062e \u0627\u0644\u0639\u0645\u0644 \u0628\u0642\u0627\u0646\u0648\u0646 \u0631\u0633\u0648\u0645 \u0645\u0633\u062a\u062e\u062f\u0645\u064a \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0645\u0648\u0635\u0648\u0641\u0629 (PDUFA) \u0641\u064a 31 \u0623\u063a\u0633\u0637\u0633 2025. \u0643\u0645\u0627 \u0623\u0643\u062f\u062a \u0627\u0644\u0644\u062c\u0646\u0629 \u0627\u0644\u0627\u0633\u062a\u0634\u0627\u0631\u064a\u0629 FDA \u0639\u0632\u0645\u0647\u0627 \u0639\u0644\u0649 \u0639\u0642\u062f \u0627\u062c\u062a\u0645\u0627\u0639 \u0644\u0644\u062c\u0646\u0629 \u0627\u0644\u0627\u0633\u062a\u0634\u0627\u0631\u064a\u0629\u060c \u0639\u0644\u0649 \u0627\u0644\u0631\u063a\u0645 \u0645\u0646 \u0623\u0646\u0647 \u0644\u0645 \u064a\u062a\u0645 \u062a\u062d\u062f\u064a\u062f \u0645\u0648\u0639\u062f \u0631\u0633\u0645\u064a \u0628\u0639\u062f.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-deramiocel\">\u0645\u0627 \u0647\u0648 \u062f\u064a\u0631\u0627\u0645\u064a\u0648\u0633\u064a\u0644\u061f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u064a\u062a\u0643\u0648\u0646 Deramiocel (CAP-1002) \u0645\u0646 \u062e\u0644\u0627\u064a\u0627 \u0645\u0634\u062a\u0642\u0629 \u0645\u0646 \u0627\u0644\u063a\u0644\u0627\u0641 \u0627\u0644\u0642\u0644\u0628\u064a (CDCs)\u060c \u0648\u0647\u064a \u0645\u062c\u0645\u0648\u0639\u0629 \u0646\u0627\u062f\u0631\u0629 \u0645\u0646 \u062e\u0644\u0627\u064a\u0627 \u0627\u0644\u0642\u0644\u0628 \u0627\u0644\u062a\u064a \u0623\u0638\u0647\u0631\u062a \u0627\u0644\u062f\u0631\u0627\u0633\u0627\u062a \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0648\u0645\u0627 \u0642\u0628\u0644 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0623\u0646\u0647\u0627 \u062a\u0645\u0627\u0631\u0633 \u062a\u0623\u062b\u064a\u0631\u0627\u062a \u0642\u0648\u064a\u0629 \u0641\u064a \u062a\u0639\u062f\u064a\u0644 \u0627\u0644\u0645\u0646\u0627\u0639\u0629 \u0648\u0645\u0636\u0627\u062f\u0627\u062a \u0627\u0644\u062a\u0644\u064a\u0641 \u0641\u064a \u0627\u0644\u062d\u0641\u0627\u0638 \u0639\u0644\u0649 \u0648\u0638\u064a\u0641\u0629 \u0627\u0644\u0642\u0644\u0628 \u0648\u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0627\u0644\u0647\u064a\u0643\u0644\u064a\u0629 \u0641\u064a \u062d\u0627\u0644\u0627\u062a \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0645\u062b\u0644 \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0627\u0644\u062f\u0648\u0634\u064a\u0646\u064a. - \u0627\u0642\u0631\u0623 \u0627\u0644\u0645\u0632\u064a\u062f: <a href=\"https:\/\/dmdwarrior.com\/ar\/what-is-deramiocel\/\">\u0645\u0627 \u0647\u0648 Deramiocel\u061f \u0645\u0627 \u0647\u064a \u0648\u0638\u064a\u0641\u0629 CAP-1002\u061f<\/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"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/3798","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/comments?post=3798"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/3798\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media\/3800"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media?parent=3798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/categories?post=3798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/tags?post=3798"}],"curies":[{"name":"\u0648\u0648\u0631\u062f\u0628\u0631\u064a\u0633","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}