{"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\/pt\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/","title":{"rendered":"Capricor Therapeutics anuncia a conclus\u00e3o da reuni\u00e3o de revis\u00e3o de meio de ciclo com FDA sobre Deramiocel para o tratamento da cardiomiopatia da distrofia muscular de Duchenne"},"content":{"rendered":"<p class=\"wp-block-paragraph\">A Capricor Therapeutics, uma empresa de biotecnologia que desenvolve terapias baseadas em c\u00e9lulas transformadoras e exossomos para o tratamento de doen\u00e7as raras, anunciou hoje a conclus\u00e3o de uma reuni\u00e3o de revis\u00e3o de meio de ciclo com a Food and Drug Administration (FDA) dos EUA para o Pedido de Licen\u00e7a Biol\u00f3gica (BLA) da empresa, buscando aprova\u00e7\u00e3o total para o deramiocel, uma terapia celular experimental, como tratamento para pacientes diagnosticados com cardiomiopatia da distrofia muscular de Duchenne (DMD).<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u00cdndice<\/h2><nav><ul><li><a href=\"#is-deramiocel-fda-approved\">O Deramiocel e o FDA s\u00e3o aprovados?<\/a><\/li><li><a href=\"#what-is-deramiocel\">O que \u00e9 Deramiocel?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"is-deramiocel-fda-approved\">O Deramiocel e o FDA s\u00e3o aprovados?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Durante a reuni\u00e3o, o FDA declarou que nenhuma defici\u00eancia significativa foi identificada pelo Comit\u00ea de Revis\u00e3o e que o pacote est\u00e1 no caminho certo para uma data de a\u00e7\u00e3o da Lei de Taxas para Usu\u00e1rios de Medicamentos Prescritos (PDUFA) em 31 de agosto de 2025. O FDA tamb\u00e9m confirmou sua inten\u00e7\u00e3o de realizar uma reuni\u00e3o do comit\u00ea consultivo, embora uma data oficial ainda n\u00e3o tenha sido definida.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-deramiocel\">O que \u00e9 Deramiocel?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Deramiocel (CAP-1002) consiste em c\u00e9lulas derivadas da cardiosfera alog\u00eanica (CDCs), uma popula\u00e7\u00e3o rara de c\u00e9lulas card\u00edacas que, em estudos pr\u00e9-cl\u00ednicos e cl\u00ednicos, demonstraram exercer potentes a\u00e7\u00f5es imunomoduladoras e antifibr\u00f3ticas na preserva\u00e7\u00e3o da fun\u00e7\u00e3o muscular card\u00edaca e esquel\u00e9tica em distrofias como a DMD. \u2013 Leia mais: <a href=\"https:\/\/dmdwarrior.com\/pt\/what-is-deramiocel\/\">O que \u00e9 Deramiocel? O que o CAP-1002 faz?<\/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\/pt\/wp-json\/wp\/v2\/posts\/3798","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=3798"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/3798\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media\/3800"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media?parent=3798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/categories?post=3798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/tags?post=3798"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}