{"id":5295,"date":"2025-12-08T16:05:39","date_gmt":"2025-12-08T13:05:39","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=5295"},"modified":"2025-12-08T16:08:05","modified_gmt":"2025-12-08T13:08:05","slug":"dyne-therapeutics-to-apply-for-accelerated-approval-in-q2-2026-for-exon-51-skipping-therapy-dyne-251-z-rostudirsen","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/es\/dyne-therapeutics-to-apply-for-accelerated-approval-in-q2-2026-for-exon-51-skipping-therapy-dyne-251-z-rostudirsen\/","title":{"rendered":"Dyne Therapeutics solicitar\u00e1 la aprobaci\u00f3n acelerada en el segundo trimestre de 2026 para la terapia de omisi\u00f3n del ex\u00f3n 51 (DYNE-251)"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Dyne Therapeutics anunci\u00f3 resultados positivos de la cohorte de expansi\u00f3n de registro (REC) de su ensayo de fase 1\/2 DELIVER que eval\u00faa zeleciment rostudirsen (z-rostudirsen, tambi\u00e9n conocido como DYNE-251) en individuos con distrofia muscular de Duchenne (DMD) susceptibles de omisi\u00f3n del ex\u00f3n 51.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Descubra ahora:<\/strong> <a href=\"https:\/\/dmdwarrior.com\/es\/mutations-and-deletions-amenable-to-exon-51-skipping-therapies-dmd\/\" target=\"_blank\" rel=\"noreferrer noopener\">Mutaciones y deleciones susceptibles de terapias de omisi\u00f3n del ex\u00f3n 51<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Resultados del ensayo cl\u00ednico DYNE-251<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>La cohorte de expansi\u00f3n de registro (REC) cumpli\u00f3 el criterio de valoraci\u00f3n principal, demostrando un aumento estad\u00edsticamente significativo de distrofina a 5,46% a los 6 meses (ajustado al contenido muscular; p &lt; 0,0001), replicando el mismo cambio de 7 veces desde el valor inicial observado previamente en la dosis de registro.<\/li>\n\n\n\n<li><strong>Se observ\u00f3 una mejor\u00eda funcional en m\u00faltiples criterios de valoraci\u00f3n cl\u00ednicos a los 6 meses en REC; la funci\u00f3n pulmonar se conserv\u00f3 a los 6 meses.<\/strong><\/li>\n\n\n\n<li>Los nuevos resultados positivos a largo plazo del ensayo DELIVER mostraron una mejora funcional sostenida en todos los puntos finales evaluados durante 24 meses.<\/li>\n\n\n\n<li><strong>Perfil de seguridad y tolerabilidad favorable continuo \u2013<\/strong><\/li>\n\n\n\n<li>La solicitud de aprobaci\u00f3n acelerada en EE. UU. est\u00e1 prevista para el segundo trimestre de 2026<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sigue esta p\u00e1gina<\/strong>&nbsp;&gt;&gt;&gt;&nbsp;<a href=\"https:\/\/dmdwarrior.com\/es\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">Todos los ensayos cl\u00ednicos para la distrofia muscular de Duchenne<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Dyne Therapeutics announced positive topline results from the Registrational Expansion Cohort (REC) of its Phase 1\/2 DELIVER trial evaluating zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) in individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. Discover Now: Mutations and Deletions Amenable to Exon 51 Skipping Therapies Results of DYNE-251 Clinical Trial Follow [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5297,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[143,208,145,122,193,421,194,460],"class_list":["post-5295","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-dyne","tag-dyne-therapeutics","tag-dyne-251","tag-exon-51","tag-exon-51-skipping","tag-exon-51-skipping-therapy","tag-exon-51-treatment","tag-z-rostudirsen"],"subtitle":"Dyne Therapeutics anunci\u00f3 que su cohorte de expansi\u00f3n de registro (REC) cumpli\u00f3 con su criterio de valoraci\u00f3n principal, demostrando un aumento estad\u00edsticamente significativo en la expresi\u00f3n de distrofina ajustada al contenido muscular a 5,46% de lo normal a los seis meses (p","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/5295","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/comments?post=5295"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/posts\/5295\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media\/5297"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/media?parent=5295"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/categories?post=5295"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/es\/wp-json\/wp\/v2\/tags?post=5295"}],"curies":[{"name":"gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}