{"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\/tr\/capricor-therapeutics-provides-regulatory-update-on-deramiocel-bla-for-duchenne-muscular-dystrophy\/","title":{"rendered":"Capricor Therapeutics, Duchenne Musk\u00fcler Distrofisi i\u00e7in Deramiocel BLA&#039;ya \u0130li\u015fkin D\u00fczenleyici G\u00fcncelleme Sa\u011fl\u0131yor"},"content":{"rendered":"<p class=\"wp-block-paragraph\">FDA&#039;nin devam eden incelemesinin bir par\u00e7as\u0131 olarak, \u015eirkete \u015fu anda bir Dan\u0131\u015fma Komitesi toplant\u0131s\u0131n\u0131n belirtilmedi\u011fi bildirildi. BLA, 31 A\u011fustos 2025&#039;te Re\u00e7eteli \u0130la\u00e7 Kullan\u0131c\u0131 \u00dccreti Yasas\u0131 (PDUFA) hedef eylem tarihiyle \u00d6ncelikli \u0130nceleme alt\u0131nda kalmaya devam ediyor.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA, \u015fu anda bir Dan\u0131\u015fma Kurulu toplant\u0131s\u0131n\u0131n gerekli olmad\u0131\u011f\u0131n\u0131 belirtti.<\/li>\n\n\n\n<li>Y\u00fcz y\u00fcze ge\u00e7 d\u00f6nem de\u011ferlendirme toplant\u0131s\u0131n\u0131n temmuz ortas\u0131nda yap\u0131lmas\u0131 planlan\u0131yor.<\/li>\n\n\n\n<li>Biyolojik Lisans Ba\u015fvurusu (BLA), 31 A\u011fustos 2025 PDUFA hedef eylem tarihiyle \u00d6ncelikli \u0130nceleme alt\u0131nda kalmaya devam ediyor.<\/li>\n\n\n\n<li>PPMD 2025 Konferans\u0131nda sunulan d\u00f6rt y\u0131ll\u0131k veriler, s\u00fcrd\u00fcr\u00fclebilir kalp fonksiyonunu g\u00f6stermektedir.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Capricor yak\u0131n zamanda 2025 Parent Project Muscular Dystrophy (PPMD) Konferans\u0131&#039;nda HOPE-2 A\u00e7\u0131k Etiketli Uzatma (OLE) \u00e7al\u0131\u015fmas\u0131ndan d\u00f6rt y\u0131ll\u0131k verileri sundu ve bu, hem kardiyak hem de iskelet kas\u0131 fonksiyonunun \u00f6l\u00e7\u00fcmlerini i\u00e7eren DMD&#039;deki en uzun s\u00fcreli tedavi veri k\u00fcmelerinden birini temsil ediyor. Veriler, uzun vadeli Deramiocel tedavisinden elde edilen klinik faydan\u0131n yan\u0131 s\u0131ra kardiyak fonksiyonun s\u00fcrekli korundu\u011funu g\u00f6sterdi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Devam\u0131n\u0131 oku: <a href=\"https:\/\/dmdwarrior.com\/tr\/capricor-therapeutics-announces-positive-4-year-data-of-deramiocel-cap-1002-in-duchenne-muscular-dystrophy\/\" target=\"_blank\" rel=\"noreferrer noopener\">Capricor Therapeutics, Duchenne Musk\u00fcler Distrofi'de Deramiocel'in (CAP-1002) 4 Y\u0131ll\u0131k Olumlu Verilerini Duyurdu<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Capricor hisseleri neden d\u00fc\u015f\u00fcyor?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Capricor Therapeutics hisseleri Pazartesi g\u00fcn\u00fc d\u00fc\u015ft\u00fc. FDA, \u015firketin Duchenne kas distrofisi i\u00e7in h\u00fccre terapisi i\u00e7in \u015fu anda bir Dan\u0131\u015fma Komitesi toplant\u0131s\u0131n\u0131n gerekli olmad\u0131\u011f\u0131n\u0131 s\u00f6yledi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Haziran ay\u0131nda \u015firket, FDA&#039;nin \u00fcretim tesisini denetledi\u011fini ve \u00f6nemli bir sorun bulunmad\u0131\u011f\u0131n\u0131 duyurdu. Ancak son geli\u015fmeler, tedavinin etkinli\u011fi konusunda \u015f\u00fcpheler uyand\u0131rd\u0131.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Capricor hisseleri haberin duyulmas\u0131ndan bu yana Cuma g\u00fcn\u00fcnden bu yana yakla\u015f\u0131k 30% d\u00fc\u015ft\u00fc.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">H\u00fccre ve gen terapileri alan\u0131nda \u00e7al\u0131\u015fan bir savunuculuk \u00f6rg\u00fct\u00fc, bu alanda d\u00fczenleyici kararlar\u0131n ve klinik \u00e7al\u0131\u015fmalar\u0131n \u00f6nemini vurgulad\u0131.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Capricor hisseleri Pazartesi g\u00fcn\u00fc 11.6% d\u00fc\u015f\u00fc\u015fle $7.30&#039;dan i\u015flem g\u00f6r\u00fcyor.<\/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\/tr\/wp-json\/wp\/v2\/posts\/3996","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=3996"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/3996\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/3998"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=3996"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=3996"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=3996"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}