{"id":3996,"date":"2025-06-24T16:56:02","date_gmt":"2025-06-24T13:56:02","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3996"},"modified":"2025-06-24T16:56:03","modified_gmt":"2025-06-24T13:56:03","slug":"capricor-therapeutics-provides-regulatory-update-on-deramiocel-bla-for-duchenne-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/ar\/capricor-therapeutics-provides-regulatory-update-on-deramiocel-bla-for-duchenne-muscular-dystrophy\/","title":{"rendered":"Capricor Therapeutics \u064a\u0648\u0641\u0631 \u062a\u062d\u062f\u064a\u062b\u064b\u0627 \u062a\u0646\u0638\u064a\u0645\u064a\u064b\u0627 \u0628\u0634\u0623\u0646 Deramiocel BLA \u0644\u0645\u0631\u0636 \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u062f\u0648\u0634\u064a\u0646"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u0641\u064a \u0625\u0637\u0627\u0631 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0645\u0633\u062a\u0645\u0631\u0629 \u0644\u0640 FDA\u060c \u0623\u064f\u0628\u0644\u063a\u062a \u0627\u0644\u0634\u0631\u0643\u0629 \u0628\u0623\u0646\u0647 \u0644\u064a\u0633 \u0645\u0646 \u0627\u0644\u0645\u0642\u0631\u0631 \u0639\u0642\u062f \u0627\u062c\u062a\u0645\u0627\u0639 \u0644\u0644\u062c\u0646\u0629 \u0627\u0644\u0627\u0633\u062a\u0634\u0627\u0631\u064a\u0629 \u0641\u064a \u0627\u0644\u0648\u0642\u062a \u0627\u0644\u062d\u0627\u0644\u064a. \u0648\u0644\u0627 \u064a\u0632\u0627\u0644 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (BLA) \u0642\u064a\u062f \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0623\u0648\u0644\u064a\u0629\u060c \u0645\u0639 \u062a\u062d\u062f\u064a\u062f \u062a\u0627\u0631\u064a\u062e \u0645\u0633\u062a\u0647\u062f\u0641 \u0644\u062a\u0637\u0628\u064a\u0642 \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.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0623\u0634\u0627\u0631\u062a FDA \u0625\u0644\u0649 \u0623\u0646\u0647 \u0644\u064a\u0633 \u0645\u0646 \u0627\u0644\u0636\u0631\u0648\u0631\u064a \u0639\u0642\u062f \u0627\u062c\u062a\u0645\u0627\u0639 \u0644\u0644\u062c\u0646\u0629 \u0627\u0644\u0627\u0633\u062a\u0634\u0627\u0631\u064a\u0629 \u0641\u064a \u0647\u0630\u0627 \u0627\u0644\u0648\u0642\u062a.<\/li>\n\n\n\n<li>\u0645\u0646 \u0627\u0644\u0645\u0642\u0631\u0631 \u0639\u0642\u062f \u0627\u062c\u062a\u0645\u0627\u0639 \u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u062f\u0648\u0631\u0629 \u0627\u0644\u0645\u062a\u0623\u062e\u0631\u0629 \u0634\u062e\u0635\u064a\u064b\u0627 \u0641\u064a \u0645\u0646\u062a\u0635\u0641 \u064a\u0648\u0644\u064a\u0648.<\/li>\n\n\n\n<li>\u064a\u0638\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 (BLA) \u0642\u064a\u062f \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0623\u0648\u0644\u064a\u0629 \u0645\u0639 \u062a\u0627\u0631\u064a\u062e \u0625\u062c\u0631\u0627\u0621 PDUFA \u0627\u0644\u0645\u0633\u062a\u0647\u062f\u0641 \u0641\u064a 31 \u0623\u063a\u0633\u0637\u0633 2025.<\/li>\n\n\n\n<li>\u0623\u0638\u0647\u0631\u062a \u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0633\u0646\u0648\u0627\u062a \u0627\u0644\u0623\u0631\u0628\u0639 \u0627\u0644\u062a\u064a \u062a\u0645 \u062a\u0642\u062f\u064a\u0645\u0647\u0627 \u0641\u064a \u0645\u0624\u062a\u0645\u0631 PPMD 2025 \u0627\u0633\u062a\u062f\u0627\u0645\u0629 \u0648\u0638\u064a\u0641\u0629 \u0627\u0644\u0642\u0644\u0628.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0642\u062f\u0651\u0645\u062a \u0634\u0631\u0643\u0629 Capricor \u0645\u0624\u062e\u0631\u064b\u0627 \u0628\u064a\u0627\u0646\u0627\u062a\u064d \u0627\u0645\u062a\u062f\u062a \u0644\u0623\u0631\u0628\u0639 \u0633\u0646\u0648\u0627\u062a \u0645\u0646 \u062f\u0631\u0627\u0633\u0629 HOPE-2 Open-Label Extension (OLE) \u0641\u064a \u0645\u0624\u062a\u0645\u0631 Parent Project Muscular Dystrophy (PPMD) \u0644\u0639\u0627\u0645 2025\u060c \u0648\u0627\u0644\u062a\u064a \u062a\u064f\u0645\u062b\u0651\u0644 \u0625\u062d\u062f\u0649 \u0623\u0642\u062f\u0645 \u0645\u062c\u0645\u0648\u0639\u0627\u062a \u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0639\u0644\u0627\u062c \u0641\u064a \u0645\u062c\u0627\u0644 \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u062f\u0648\u0634\u064a\u0646\u060c \u0628\u0645\u0627 \u0641\u064a \u0630\u0644\u0643 \u0642\u064a\u0627\u0633\u0627\u062a \u0648\u0638\u0627\u0626\u0641 \u0643\u0644\u064d\u0651 \u0645\u0646 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u0627\u0644\u0642\u0644\u0628\u064a\u0629 \u0648\u0627\u0644\u0647\u064a\u0643\u0644\u064a\u0629. \u0648\u0642\u062f \u0623\u0638\u0647\u0631\u062a \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0633\u062a\u0645\u0631\u0627\u0631 \u0627\u0644\u062d\u0641\u0627\u0638 \u0639\u0644\u0649 \u0648\u0638\u0627\u0626\u0641 \u0627\u0644\u0642\u0644\u0628\u060c \u0625\u0644\u0649 \u062c\u0627\u0646\u0628 \u0641\u0627\u0626\u062f\u0629 \u0633\u0631\u064a\u0631\u064a\u0629 \u0645\u0633\u062a\u062f\u0627\u0645\u0629 \u0645\u0646 \u0627\u0644\u0639\u0644\u0627\u062c \u0637\u0648\u064a\u0644 \u0627\u0644\u0623\u0645\u062f \u0628\u0640 Deramiocel.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0627\u0642\u0631\u0623 \u0627\u0644\u0645\u0632\u064a\u062f: <a href=\"https:\/\/dmdwarrior.com\/ar\/capricor-therapeutics-announces-positive-4-year-data-of-deramiocel-cap-1002-in-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Capricor Therapeutics \u062a\u0639\u0644\u0646 \u0639\u0646 \u0628\u064a\u0627\u0646\u0627\u062a \u0625\u064a\u062c\u0627\u0628\u064a\u0629 \u0639\u0644\u0649 \u0645\u062f\u0649 \u0623\u0631\u0628\u0639 \u0633\u0646\u0648\u0627\u062a \u0644\u0640 Deramiocel (CAP-1002) \u0641\u064a \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u062f\u0648\u0634\u064a\u0646<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u0644\u0645\u0627\u0630\u0627 \u062a\u0646\u062e\u0641\u0636 \u0623\u0633\u0647\u0645 Capricor\u061f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0627\u0646\u062e\u0641\u0636\u062a \u0623\u0633\u0647\u0645 \u0634\u0631\u0643\u0629 Capricor Therapeutics \u064a\u0648\u0645 \u0627\u0644\u0627\u062b\u0646\u064a\u0646. \u0648\u0623\u0641\u0627\u062f\u062a \u0627\u0644\u0634\u0631\u0643\u0629 \u0628\u0623\u0646\u0647 \u0644\u0627 \u062d\u0627\u062c\u0629 \u062d\u0627\u0644\u064a\u064b\u0627 \u0644\u0639\u0642\u062f \u0627\u062c\u062a\u0645\u0627\u0639 \u0644\u0644\u062c\u0646\u0629 \u0627\u0644\u0627\u0633\u062a\u0634\u0627\u0631\u064a\u0629 \u0628\u0634\u0623\u0646 \u0639\u0644\u0627\u062c \u0627\u0644\u0634\u0631\u0643\u0629 \u0627\u0644\u062e\u0644\u0648\u064a \u0644\u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u062f\u0648\u0634\u064a\u0646.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0641\u064a \u064a\u0648\u0646\u064a\u0648\u060c \u0623\u0639\u0644\u0646\u062a \u0627\u0644\u0634\u0631\u0643\u0629 \u0623\u0646 \u0645\u064f\u0646\u062a\u062c FDA \u0641\u064f\u062d\u0635 \u0641\u064a \u0645\u0646\u0634\u0623\u0629 \u062a\u0635\u0646\u064a\u0639\u0647 \u0648\u0644\u0645 \u064a\u064f\u0644\u0627\u062d\u0638 \u0623\u064a \u0645\u0634\u0627\u0643\u0644 \u062a\u064f\u0630\u0643\u0631. \u0625\u0644\u0627 \u0623\u0646 \u0627\u0644\u062a\u0637\u0648\u0631\u0627\u062a \u0627\u0644\u0623\u062e\u064a\u0631\u0629 \u0623\u062b\u0627\u0631\u062a \u0634\u0643\u0648\u0643\u064b\u0627 \u062d\u0648\u0644 \u0641\u0639\u0627\u0644\u064a\u0629 \u0627\u0644\u0639\u0644\u0627\u062c.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0627\u0646\u062e\u0641\u0636\u062a \u0623\u0633\u0647\u0645 Capricor \u0628\u0646\u062d\u0648 30% \u0645\u0646\u0630 \u064a\u0648\u0645 \u0627\u0644\u062c\u0645\u0639\u0629 \u0639\u0644\u0649 \u062e\u0644\u0641\u064a\u0629 \u0627\u0644\u0623\u062e\u0628\u0627\u0631.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0623\u0643\u062f\u062a \u0625\u062d\u062f\u0649 \u0627\u0644\u0645\u0646\u0638\u0645\u0627\u062a \u0627\u0644\u0645\u062f\u0627\u0641\u0639\u0629 \u0639\u0646 \u062d\u0642\u0648\u0642 \u0627\u0644\u0625\u0646\u0633\u0627\u0646 \u0648\u0627\u0644\u062a\u064a \u062a\u0639\u0645\u0644 \u0641\u064a \u0645\u062c\u0627\u0644 \u0639\u0644\u0627\u062c\u0627\u062a \u0627\u0644\u062e\u0644\u0627\u064a\u0627 \u0648\u0627\u0644\u062c\u064a\u0646\u0627\u062a \u0639\u0644\u0649 \u0623\u0647\u0645\u064a\u0629 \u0627\u0644\u0642\u0631\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629 \u0648\u0627\u0644\u062a\u062c\u0627\u0631\u0628 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0641\u064a \u0647\u0630\u0627 \u0627\u0644\u0645\u062c\u0627\u0644.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u064a\u062a\u0645 \u062a\u062f\u0627\u0648\u0644 \u0623\u0633\u0647\u0645 Capricor \u0639\u0646\u062f $7.30\u060c \u0628\u0627\u0646\u062e\u0641\u0627\u0636 11.6% \u064a\u0648\u0645 \u0627\u0644\u0627\u062b\u0646\u064a\u0646.<\/p>","protected":false},"excerpt":{"rendered":"<p>As part of the FDA\u2019s ongoing review, the Company has been informed that an Advisory Committee meeting is not indicated at this time. The BLA remains under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of August 31, 2025. Capricor recently presented four-year data from its HOPE-2 Open-Label Extension (OLE) [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3998,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[90,86,87,89,85,362,301],"class_list":["post-3996","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-hope-2"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/3996","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=3996"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/3996\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media\/3998"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media?parent=3996"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/categories?post=3996"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/tags?post=3996"}],"curies":[{"name":"\u0648\u0648\u0631\u062f\u0628\u0631\u064a\u0633","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}