{"id":3074,"date":"2025-03-04T15:58:05","date_gmt":"2025-03-04T12:58:05","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=3074"},"modified":"2025-03-07T12:54:37","modified_gmt":"2025-03-07T09:54:37","slug":"capricor-therapeutics-announces-fda-acceptance-for-deramiocel-to-treat-duchenne-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/pt\/capricor-therapeutics-announces-fda-acceptance-for-deramiocel-to-treat-duchenne-muscular-dystrophy\/","title":{"rendered":"Capricor Therapeutics anuncia aceita\u00e7\u00e3o do FDA e revis\u00e3o priorit\u00e1ria de seu pedido de licen\u00e7a biol\u00f3gica para Deramiocel para tratar distrofia muscular de Duchenne"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Capricor Therapeutics, a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the U.S. Food and Drug Administration (\u201cFDA\u201d) has accepted for review its Biologics License Application (\u201cBLA\u201d) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (\u201cDMD\u201d) cardiomyopathy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Additionally, the FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (\u201cPDUFA\u201d) target action date of August 31, 2025 and at this time, the FDA has not identified any potential review issues. [<a href=\"https:\/\/dmdwarrior.com\/capricor-therapeutics-submits-application-for-treatment-of-dmd-cardiomyopathy\/\" target=\"_blank\" rel=\"noreferrer noopener\">About Deramiocel<\/a>]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","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 U.S. Food and Drug Administration (\u201cFDA\u201d) has accepted for review its Biologics License Application (\u201cBLA\u201d) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (\u201cDMD\u201d) [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3075,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[90,86,87,89,85,88],"class_list":["post-3074","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-fda"],"subtitle":"Hoje, a Capricor Therapeutics anunciou que a Food and Drug Administration (\u201cFDA\u201d) dos EUA aceitou para revis\u00e3o seu Pedido de Licen\u00e7a Biol\u00f3gica (\u201cBLA\u201d) buscando aprova\u00e7\u00e3o total para o deramiocel, uma terapia celular experimental, para tratar a cardiomiopatia da distrofia muscular de Duchenne (\u201cDMD\u201d).","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/3074","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/comments?post=3074"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/3074\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media\/3075"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media?parent=3074"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/categories?post=3074"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/tags?post=3074"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}