{"id":3929,"date":"2025-06-17T16:48:33","date_gmt":"2025-06-17T13:48:33","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3929"},"modified":"2025-06-17T16:48:34","modified_gmt":"2025-06-17T13:48:34","slug":"capricor-therapeutics-announces-bmd-orphan-drug-designation-and-dmd-program-regulatory-development-for-deramiocel-cap-1002","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/ar\/capricor-therapeutics-announces-bmd-orphan-drug-designation-and-dmd-program-regulatory-development-for-deramiocel-cap-1002\/","title":{"rendered":"Capricor Therapeutics \u062a\u0639\u0644\u0646 \u0639\u0646 \u062a\u0635\u0646\u064a\u0641 \u062f\u0648\u0627\u0621 \u064a\u062a\u064a\u0645 BMD \u0648\u062a\u0637\u0648\u064a\u0631 \u0628\u0631\u0646\u0627\u0645\u062c DMD \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a \u0644\u0640 Deramiocel (CAP-1002)"},"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\u064f\u0637\u0648\u0651\u0631 \u0639\u0644\u0627\u062c\u0627\u062a \u062a\u062d\u0648\u064a\u0644\u064a\u0629 \u0642\u0627\u0626\u0645\u0629 \u0639\u0644\u0649 \u0627\u0644\u062e\u0644\u0627\u064a\u0627 \u0648\u0627\u0644\u062c\u0633\u064a\u0645\u0627\u062a \u0627\u0644\u062e\u0627\u0631\u062c\u064a\u0629 \u0644\u0639\u0644\u0627\u062c \u0627\u0644\u0623\u0645\u0631\u0627\u0636 \u0627\u0644\u0646\u0627\u062f\u0631\u0629\u060c \u0623\u0646 \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) \u0645\u0646\u062d\u062a \u062a\u0635\u0646\u064a\u0641 \u062f\u0648\u0627\u0621 \u064a\u062a\u064a\u0645 \u0644\u0640 Deramiocel (CAP-1002)\u060c \u0648\u0647\u0648 \u0627\u0644\u0645\u0631\u0634\u062d \u0627\u0644\u0631\u0626\u064a\u0633\u064a \u0644\u0644\u0639\u0644\u0627\u062c \u0627\u0644\u062e\u0644\u0648\u064a \u0644\u0644\u0634\u0631\u0643\u0629\u060c \u0644\u0639\u0644\u0627\u062c \u0636\u0645\u0648\u0631 \u0628\u064a\u0643\u0631 \u0627\u0644\u0639\u0636\u0644\u064a (BMD). \u064a\u064f\u0639\u0632\u0632 \u0647\u0630\u0627 \u0627\u0644\u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0645\u0643\u0627\u0646\u0629 \u0627\u0644\u0627\u0633\u062a\u0631\u0627\u062a\u064a\u062c\u064a\u0629 \u0644\u0634\u0631\u0643\u0629 Capricor \u0641\u064a \u062a\u0637\u0648\u064a\u0631\u0647\u0627 \u0645\u0646\u0635\u0629 \u0645\u062a\u0643\u0627\u0645\u0644\u0629 \u062a\u0633\u062a\u0647\u062f\u0641 \u0645\u0636\u0627\u0639\u0641\u0627\u062a \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0627\u0644\u0642\u0644\u0628\u064a\u0629 \u0648\u0627\u0644\u0647\u064a\u0643\u0644\u064a\u0629\u060c \u0648\u064a\u064f\u0648\u0633\u0651\u0639 \u0627\u0644\u0625\u0645\u0643\u0627\u0646\u0627\u062a \u0627\u0644\u062a\u062c\u0627\u0631\u064a\u0629 \u0644\u0623\u0635\u0644\u0647\u0627 \u0627\u0644\u0631\u0627\u0626\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> \u2013<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Capricor Therapeutics \u064a\u062a\u0642\u062f\u0645 \u0628\u062e\u0637\u0648\u0627\u062a \u0648\u0627\u062b\u0642\u0629<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u0645\u0646\u062d\u062a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 FDA \u062a\u0635\u0646\u064a\u0641 \u062f\u0648\u0627\u0621 \u064a\u062a\u064a\u0645 \u0644\u0640 Deramiocel \u0644\u0639\u0644\u0627\u062c \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0628\u064a\u0643\u0631\u060c \u0645\u0645\u0627 \u0648\u0633\u0639 \u0646\u0637\u0627\u0642 \u062a\u0631\u0643\u064a\u0632 Capricor \u0641\u064a \u0627\u0644\u0623\u0645\u0631\u0627\u0636 \u0627\u0644\u0639\u0635\u0628\u064a\u0629 \u0627\u0644\u0639\u0636\u0644\u064a\u0629<\/strong><\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u0644\u0627 \u064a\u0632\u0627\u0644 Capricor \u0639\u0644\u0649 \u0627\u0644\u0645\u0633\u0627\u0631 \u0627\u0644\u0635\u062d\u064a\u062d \u062d\u062a\u0649 \u062a\u0627\u0631\u064a\u062e 31 \u0623\u063a\u0633\u0637\u0633 2025\u060c \u0648\u0647\u0648 \u062a\u0627\u0631\u064a\u062e \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) \u0644\u0640 Deramiocel \u0641\u064a \u0636\u0645\u0648\u0631 \u062f\u0648\u0634\u064a\u0646 \u0627\u0644\u0639\u0636\u0644\u064a \u0628\u0639\u062f \u0641\u062d\u0635 \u0645\u0627 \u0642\u0628\u0644 \u0627\u0644\u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0646\u0627\u062c\u062d \u0644\u0640 FDA<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0636\u0645\u0648\u0631 \u0628\u064a\u0643\u0631 \u0627\u0644\u0639\u0636\u0644\u064a\u060c \u0645\u062b\u0644 \u0636\u0645\u0648\u0631 \u062f\u0648\u0634\u064a\u0646 \u0627\u0644\u0639\u0636\u0644\u064a (DMD)\u060c \u0647\u0648 \u0627\u0636\u0637\u0631\u0627\u0628 \u0639\u0635\u0628\u064a \u0639\u0636\u0644\u064a \u062a\u0642\u062f\u0645\u064a \u0645\u0631\u062a\u0628\u0637 \u0628\u0627\u0644\u0643\u0631\u0648\u0645\u0648\u0633\u0648\u0645 X \u0648\u0627\u0644\u0630\u064a \u064a\u0624\u062f\u064a \u0625\u0644\u0649 \u062a\u062f\u0647\u0648\u0631 \u0643\u0628\u064a\u0631 \u0641\u064a \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0627\u0644\u0647\u064a\u0643\u0644\u064a\u0629 \u0648\u0627\u0644\u0642\u0644\u0628\u064a\u0629 \u0628\u0645\u0631\u0648\u0631 \u0627\u0644\u0648\u0642\u062a. \u064a\u062a\u0645 \u062a\u0637\u0648\u064a\u0631 Deramiocel \u0644\u0645\u0639\u0627\u0644\u062c\u0629 \u0643\u0644\u0627 \u062c\u0627\u0646\u0628\u064a \u0639\u0644\u0645 \u0627\u0644\u0623\u0645\u0631\u0627\u0636\u060c \u0628\u0645\u0627 \u0641\u064a \u0630\u0644\u0643 \u0627\u0639\u062a\u0644\u0627\u0644 \u0639\u0636\u0644\u0629 \u0627\u0644\u0642\u0644\u0628\u060c \u0648\u0647\u0648 \u0645\u0633\u0627\u0647\u0645 \u0623\u0633\u0627\u0633\u064a \u0641\u064a \u0627\u0644\u0625\u0635\u0627\u0628\u0629 \u0648\u0627\u0644\u0648\u0641\u064a\u0627\u062a \u0644\u062f\u0649 \u0627\u0644\u0645\u0631\u0636\u0649 \u0627\u0644\u0630\u064a\u0646 \u064a\u0639\u0627\u0646\u0648\u0646 \u0645\u0646 \u0643\u0644 \u0645\u0646 \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0638\u0627\u0645 \u0648 \u0636\u0645\u0648\u0631 \u062f\u0648\u0634\u064a\u0646 \u0627\u0644\u0639\u0636\u0644\u064a.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u064a\u0638\u0644 \u0637\u0644\u0628 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (BLA) \u0644\u0640 Capricor \u0644\u0640 Deramiocel \u0641\u064a DMD \u0642\u064a\u062f \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0623\u0648\u0644\u064a\u0629\u060c \u0645\u0639 \u062a\u0627\u0631\u064a\u062e \u0639\u0645\u0644 PDUFA \u0627\u0644\u0645\u0633\u062a\u0647\u062f\u0641 \u0641\u064a 31 \u0623\u063a\u0633\u0637\u0633 2025.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u064a\u062a\u0639\u0644\u0645 \u0623\u0643\u062b\u0631<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/ar\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/\">Capricor Therapeutics \u064a\u0639\u0644\u0646 \u0639\u0646 \u0627\u0646\u062a\u0647\u0627\u0621 \u0627\u062c\u062a\u0645\u0627\u0639 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629<\/a><\/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 that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Deramiocel (CAP-1002), the company\u2019s lead cell therapy candidate, for the potential treatment of Becker Muscular Dystrophy (BMD). This designation strengthens Capricor\u2019s strategic [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3931,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[361,90,86,87,89,85,117,362,88],"class_list":["post-3929","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-bmd","tag-cap-1002","tag-capricor","tag-capricor-therapeutics","tag-cardiomyopathy","tag-deramiocel","tag-dmd","tag-dmd-cardiomyopathy","tag-fda"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/3929","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=3929"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/3929\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media\/3931"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media?parent=3929"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/categories?post=3929"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/tags?post=3929"}],"curies":[{"name":"\u0648\u0648\u0631\u062f\u0628\u0631\u064a\u0633","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}