{"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\/tr\/capricor-therapeutics-deramiocel-mid-cycle-review-meeting-with-fda\/","title":{"rendered":"Capricor Therapeutics, Duchenne Musk\u00fcler Distrofi Kardiyomiyopatisinin Tedavisi i\u00e7in Deramiocel&#039;de FDA ile Orta D\u00f6ng\u00fc \u0130nceleme Toplant\u0131s\u0131n\u0131n Tamamland\u0131\u011f\u0131n\u0131 Duyurdu"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Nadir hastal\u0131klar\u0131n tedavisi i\u00e7in d\u00f6n\u00fc\u015ft\u00fcr\u00fcc\u00fc h\u00fccre ve ekzosom bazl\u0131 tedaviler geli\u015ftiren bir biyoteknoloji \u015firketi olan Capricor Therapeutics, bug\u00fcn Duchenne kas distrofisi (DMD) kardiyomiyopatisi te\u015fhisi konan hastalar\u0131n tedavisi i\u00e7in ara\u015ft\u0131rma a\u015famas\u0131ndaki bir h\u00fccre tedavisi olan deramiocel i\u00e7in tam onay talep eden \u015eirketin Biyolojik Lisans Ba\u015fvurusu (BLA) i\u00e7in ABD G\u0131da ve \u0130la\u00e7 Dairesi (FDA) ile bir orta d\u00f6ng\u00fc inceleme toplant\u0131s\u0131n\u0131n tamamland\u0131\u011f\u0131n\u0131 duyurdu.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0130\u00e7indekiler<\/h2><nav><ul><li><a href=\"#is-deramiocel-fda-approved\">Deramiocel FDA Onayl\u0131 m\u0131?<\/a><\/li><li><a href=\"#what-is-deramiocel\">Deramiocel Nedir?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"is-deramiocel-fda-approved\">Deramiocel FDA Onayl\u0131 m\u0131?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Toplant\u0131 s\u0131ras\u0131nda FDA, \u0130nceleme Komitesi taraf\u0131ndan \u00f6nemli bir eksiklik tespit edilmedi\u011fini ve paketin 31 A\u011fustos 2025&#039;te Re\u00e7eteli \u0130la\u00e7 Kullan\u0131c\u0131 \u00dccreti Yasas\u0131 (PDUFA) eylem tarihi i\u00e7in do\u011fru yolda oldu\u011funu belirtti. FDA ayr\u0131ca resmi bir tarih hen\u00fcz belirlenmemi\u015f olsa da bir dan\u0131\u015fma komitesi toplant\u0131s\u0131 d\u00fczenleme niyetini de do\u011frulad\u0131.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-deramiocel\">Deramiocel Nedir?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Deramiocel (CAP-1002), DMD gibi distrofiyopatilerde kardiyak ve iskelet kas\u0131 fonksiyonunun korunmas\u0131nda g\u00fc\u00e7l\u00fc imm\u00fcnomod\u00fclat\u00f6r ve anti-fibrotik etkiler g\u00f6sterdi\u011fi klinik \u00f6ncesi ve klinik \u00e7al\u0131\u015fmalarda g\u00f6sterilen nadir bir kardiyak h\u00fccre pop\u00fclasyonu olan allojenik kardiyosfer k\u00f6kenli h\u00fccrelerden (CDC&#039;ler) olu\u015fur. \u2013 Daha Fazlas\u0131n\u0131 Okuyun: <a href=\"https:\/\/dmdwarrior.com\/tr\/what-is-deramiocel\/\">Deramiocel nedir? CAP-1002 ne i\u015fe yarar?<\/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\/tr\/wp-json\/wp\/v2\/posts\/3798","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=3798"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3798\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/3800"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=3798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=3798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=3798"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}