{"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\/hi\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/","title":{"rendered":"Capricor Therapeutics \u0928\u0947 \u0921\u094d\u092f\u0942\u091a\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 \u0915\u093e\u0930\u094d\u0921\u093f\u092f\u094b\u092e\u093e\u092f\u094b\u092a\u0948\u0925\u0940 \u0915\u0947 \u0909\u092a\u091a\u093e\u0930 \u0915\u0947 \u0932\u093f\u090f Deramiocel \u092a\u0930 FDA \u0915\u0947 \u0938\u093e\u0925 \u092e\u0927\u094d\u092f-\u091a\u0915\u094d\u0930 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092c\u0948\u0920\u0915 \u0915\u0947 \u0938\u092e\u093e\u092a\u0928 \u0915\u0940 \u0918\u094b\u0937\u0923\u093e \u0915\u0940"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Capricor Therapeutics, \u090f\u0915 \u091c\u0948\u0935 \u092a\u094d\u0930\u094c\u0926\u094d\u092f\u094b\u0917\u093f\u0915\u0940 \u0915\u0902\u092a\u0928\u0940 \u091c\u094b \u0926\u0941\u0930\u094d\u0932\u092d \u0930\u094b\u0917\u094b\u0902 \u0915\u0947 \u0909\u092a\u091a\u093e\u0930 \u0915\u0947 \u0932\u093f\u090f \u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928\u0915\u093e\u0930\u0940 \u0915\u094b\u0936\u093f\u0915\u093e \u0914\u0930 \u090f\u0915\u094d\u0938\u094b\u0938\u094b\u092e-\u0906\u0927\u093e\u0930\u093f\u0924 \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u093e \u0935\u093f\u0915\u0938\u093f\u0924 \u0915\u0930 \u0930\u0939\u0940 \u0939\u0948, \u0928\u0947 \u0906\u091c \u0915\u0902\u092a\u0928\u0940 \u0915\u0947 \u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 (BLA) \u0915\u0947 \u0932\u093f\u090f \u0905\u092e\u0947\u0930\u093f\u0915\u0940 \u0916\u093e\u0926\u094d\u092f \u090f\u0935\u0902 \u0914\u0937\u0927\u093f \u092a\u094d\u0930\u0936\u093e\u0938\u0928 (FDA) \u0915\u0947 \u0938\u093e\u0925 \u092e\u0927\u094d\u092f-\u091a\u0915\u094d\u0930 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092c\u0948\u0920\u0915 \u092a\u0942\u0930\u0940 \u0939\u094b\u0928\u0947 \u0915\u0940 \u0918\u094b\u0937\u0923\u093e \u0915\u0940, \u091c\u093f\u0938\u092e\u0947\u0902 \u0921\u094d\u092f\u0942\u091a\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 (DMD) \u0915\u093e\u0930\u094d\u0921\u093f\u092f\u094b\u092e\u093e\u092f\u094b\u092a\u0948\u0925\u0940 \u0938\u0947 \u092a\u0940\u0921\u093c\u093f\u0924 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0909\u092a\u091a\u093e\u0930 \u0915\u0947 \u0932\u093f\u090f \u0921\u0947\u0930\u093e\u092e\u093f\u092f\u094b\u0938\u0947\u0932, \u090f\u0915 \u091c\u093e\u0902\u091a\u093e\u0924\u094d\u092e\u0915 \u0915\u094b\u0936\u093f\u0915\u093e \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u093e, \u0915\u0947 \u0932\u093f\u090f \u092a\u0942\u0930\u094d\u0923 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092e\u093e\u0902\u0917\u093e \u0917\u092f\u093e\u0964<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0935\u093f\u0937\u092f\u0938\u0942\u091a\u0940<\/h2><nav><ul><li><a href=\"#is-deramiocel-fda-approved\">\u0915\u094d\u092f\u093e Deramiocel FDA \u0938\u094d\u0935\u0940\u0915\u0943\u0924 \u0939\u0948?<\/a><\/li><li><a href=\"#what-is-deramiocel\">\u0921\u0947\u0930\u093e\u092e\u093f\u092f\u094b\u0938\u0947\u0932 \u0915\u094d\u092f\u093e \u0939\u0948?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"is-deramiocel-fda-approved\">\u0915\u094d\u092f\u093e Deramiocel FDA \u0938\u094d\u0935\u0940\u0915\u0943\u0924 \u0939\u0948?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u092c\u0948\u0920\u0915 \u0915\u0947 \u0926\u094c\u0930\u093e\u0928, FDA \u0928\u0947 \u0915\u0939\u093e \u0915\u093f \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0938\u092e\u093f\u0924\u093f \u0926\u094d\u0935\u093e\u0930\u093e \u0915\u094b\u0908 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0915\u092e\u0940 \u0928\u0939\u0940\u0902 \u092a\u093e\u0908 \u0917\u0908 \u0939\u0948 \u0914\u0930 \u092f\u0939 \u092a\u0948\u0915\u0947\u091c 31 \u0905\u0917\u0938\u094d\u0924, 2025 \u0915\u0940 \u092a\u094d\u0930\u093f\u0938\u094d\u0915\u094d\u0930\u093f\u092a\u094d\u0936\u0928 \u0921\u094d\u0930\u0917 \u092f\u0942\u091c\u0930 \u092b\u0940\u0938 \u090f\u0915\u094d\u091f (PDUFA) \u0915\u093e\u0930\u094d\u0930\u0935\u093e\u0908 \u0924\u093f\u0925\u093f \u0915\u0947 \u0905\u0928\u0941\u0930\u0942\u092a \u0939\u0948\u0964 FDA \u0928\u0947 \u0938\u0932\u093e\u0939\u0915\u093e\u0930 \u0938\u092e\u093f\u0924\u093f \u0915\u0940 \u092c\u0948\u0920\u0915 \u0906\u092f\u094b\u091c\u093f\u0924 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0905\u092a\u0928\u0947 \u0907\u0930\u093e\u0926\u0947 \u0915\u0940 \u092d\u0940 \u092a\u0941\u0937\u094d\u091f\u093f \u0915\u0940 \u0939\u0948, \u0939\u093e\u0932\u093e\u0902\u0915\u093f \u0905\u092d\u0940 \u0924\u0915 \u0906\u0927\u093f\u0915\u093e\u0930\u093f\u0915 \u0924\u093f\u0925\u093f \u0928\u093f\u0930\u094d\u0927\u093e\u0930\u093f\u0924 \u0928\u0939\u0940\u0902 \u0915\u0940 \u0917\u0908 \u0939\u0948\u0964<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-deramiocel\">\u0921\u0947\u0930\u093e\u092e\u093f\u092f\u094b\u0938\u0947\u0932 \u0915\u094d\u092f\u093e \u0939\u0948?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Deramiocel (CAP-1002) \u092e\u0947\u0902 \u090f\u0932\u094b\u091c\u0947\u0928\u093f\u0915 \u0915\u093e\u0930\u094d\u0921\u093f\u092f\u094b\u0938\u094d\u092b\u0940\u092f\u0930-\u0935\u094d\u092f\u0941\u0924\u094d\u092a\u0928\u094d\u0928 \u0915\u094b\u0936\u093f\u0915\u093e\u090f\u0902 (\u0938\u0940\u0921\u0940\u0938\u0940) \u0936\u093e\u092e\u093f\u0932 \u0939\u0948\u0902, \u091c\u094b \u0939\u0943\u0926\u092f \u0915\u094b\u0936\u093f\u0915\u093e\u0913\u0902 \u0915\u0940 \u090f\u0915 \u0926\u0941\u0930\u094d\u0932\u092d \u0906\u092c\u093e\u0926\u0940 \u0939\u0948, \u091c\u094b \u0921\u0940\u090f\u092e\u0921\u0940 \u091c\u0948\u0938\u0947 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u092f\u094b\u092a\u0948\u0925\u0940 \u092e\u0947\u0902 \u0939\u0943\u0926\u092f \u0914\u0930 \u0915\u0902\u0915\u093e\u0932 \u0915\u0940 \u092e\u093e\u0902\u0938\u092a\u0947\u0936\u093f\u092f\u094b\u0902 \u0915\u0947 \u0915\u093e\u0930\u094d\u092f \u0915\u0947 \u0938\u0902\u0930\u0915\u094d\u0937\u0923 \u092e\u0947\u0902 \u0936\u0915\u094d\u0924\u093f\u0936\u093e\u0932\u0940 \u0907\u092e\u094d\u092f\u0942\u0928\u094b\u092e\u0949\u0921\u0941\u0932\u0947\u091f\u0930\u0940 \u0914\u0930 \u090f\u0902\u091f\u0940-\u092b\u093e\u0907\u092c\u094d\u0930\u094b\u091f\u093f\u0915 \u0915\u094d\u0930\u093f\u092f\u093e\u090f\u0902 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u092a\u094d\u0930\u0940\u0915\u094d\u0932\u093f\u0928\u093f\u0915\u0932 \u0914\u0930 \u0915\u094d\u0932\u093f\u0928\u093f\u0915\u0932 \u0905\u0927\u094d\u092f\u092f\u0928\u094b\u0902 \u092e\u0947\u0902 \u0926\u093f\u0916\u093e\u092f\u093e \u0917\u092f\u093e \u0939\u0948\u0964 - \u0914\u0930 \u092a\u0922\u093c\u0947\u0902: <a href=\"https:\/\/dmdwarrior.com\/hi\/what-is-deramiocel\/\">Deramiocel \u0915\u094d\u092f\u093e \u0939\u0948? CAP-1002 \u0915\u094d\u092f\u093e \u0915\u0930\u0924\u093e \u0939\u0948?<\/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\/hi\/wp-json\/wp\/v2\/posts\/3798","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/comments?post=3798"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/3798\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media\/3800"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media?parent=3798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/categories?post=3798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/tags?post=3798"}],"curies":[{"name":"\u0921\u092c\u094d\u0932\u094d\u092f\u0942\u092a\u0940","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}