{"id":4794,"date":"2025-10-13T16:14:23","date_gmt":"2025-10-13T13:14:23","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4794"},"modified":"2025-11-03T20:17:29","modified_gmt":"2025-11-03T17:17:29","slug":"avidity-biosciences-announces-positive-pre-bla-meeting-with-u-s-fda-for-del-zota-in-dmd44-with-a-submission-planned-for-q1-2026","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/ar\/avidity-biosciences-announces-positive-pre-bla-meeting-with-u-s-fda-for-del-zota-in-dmd44-with-a-submission-planned-for-q1-2026\/","title":{"rendered":"\u0623\u0639\u0644\u0646\u062a \u0634\u0631\u0643\u0629 Avidity Biosciences \u0639\u0646 \u0627\u062c\u062a\u0645\u0627\u0639 \u0625\u064a\u062c\u0627\u0628\u064a \u0642\u0628\u0644 \u0627\u062a\u0641\u0627\u0642\u064a\u0629 BLA \u0645\u0639 \u0634\u0631\u0643\u0629 FDA \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 \u0644\u0640 del-zota \u0641\u064a DMD44 \u0645\u0639 \u062a\u0642\u062f\u064a\u0645 \u0645\u062e\u0637\u0637 \u0644\u0644\u0631\u0628\u0639 \u0627\u0644\u0623\u0648\u0644 \u0645\u0646 \u0639\u0627\u0645 2026"},"content":{"rendered":"

\u0623\u0639\u0644\u0646\u062a \u0634\u0631\u0643\u0629 Avidity Biosciences \u0623\u0646\u0647\u0627 \u0623\u062c\u0631\u062a \u0627\u062c\u062a\u0645\u0627\u0639\u064b\u0627 \u0625\u064a\u062c\u0627\u0628\u064a\u064b\u0627 \u0642\u0628\u0644 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u062c\u062f\u064a\u062f \u0645\u0639 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 (FDA) \u0628\u062e\u0635\u0648\u0635 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u062c\u062f\u064a\u062f \u0644\u062f\u0648\u0627\u0621 \u062f\u064a\u0644\u0628\u0627\u0633\u064a\u0628\u0627\u0631\u062a \u0632\u0648\u062a\u0627\u062f\u064a\u0631\u0633\u0646 (del-zota). \u062f\u064a\u0644-\u0632\u0648\u062a\u0627\u060c \u0627\u0644\u0630\u064a \u062d\u0635\u0644 \u0639\u0644\u0649 \u062a\u0635\u0646\u064a\u0641 \u0627\u0644\u0639\u0644\u0627\u062c \u0627\u0644\u0645\u0628\u062a\u0643\u0631\u060c \u0647\u0648 \u062f\u0648\u0627\u0621 \u062a\u062c\u0631\u064a\u0628\u064a \u0642\u064a\u062f \u0627\u0644\u062a\u0642\u064a\u064a\u0645 \u0643\u0639\u0644\u0627\u062c \u0645\u062d\u062a\u0645\u0644 \u0644\u0644\u0623\u0634\u062e\u0627\u0635 \u0627\u0644\u0645\u0635\u0627\u0628\u064a\u0646 \u0628\u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u062f\u0648\u0634\u064a\u0646 \u0627\u0644\u0630\u064a\u0646 \u0644\u062f\u064a\u0647\u0645 \u0637\u0641\u0631\u0627\u062a \u062c\u064a\u0646\u064a\u0629 \u0642\u0627\u0628\u0644\u0629 \u0644\u062a\u062e\u0637\u064a \u0627\u0644\u0625\u0643\u0633\u0648\u0646 44 (DMD44).<\/p>\n\n\n\n

\u064a\u062a\u0639\u0644\u0645 \u0623\u0643\u062b\u0631<\/strong>: \u0627\u0644\u0637\u0641\u0631\u0627\u062a \u0648\u0627\u0644\u062d\u0630\u0641 \u0627\u0644\u0642\u0627\u0628\u0644 \u0644\u0644\u0639\u0644\u0627\u062c \u0628\u062a\u062e\u0637\u064a \u0627\u0644\u0625\u0643\u0633\u0648\u0646 44<\/a><\/p>\n\n\n\n

\u062a\u0645 \u062a\u062d\u062f\u064a\u062b \u062a\u0648\u0642\u064a\u062a \u062a\u0642\u062f\u064a\u0645 \u0637\u0644\u0628 BLA \u0625\u0644\u0649 \u0627\u0644\u0631\u0628\u0639 \u0627\u0644\u0623\u0648\u0644 \u0645\u0646 \u0639\u0627\u0645 2026 \u0645\u0646 \u0627\u0644\u062a\u0648\u062c\u064a\u0647 \u0627\u0644\u0633\u0627\u0628\u0642 \u0644\u0646\u0647\u0627\u064a\u0629 \u0639\u0627\u0645 2025 \u0644\u0636\u0645\u0627\u0646 \u062d\u0635\u0648\u0644 FDA \u0639\u0644\u0649 \u0628\u064a\u0627\u0646\u0627\u062a \u0625\u0636\u0627\u0641\u064a\u0629 \u0644\u062f\u0639\u0645 \u062d\u0632\u0645\u0629 \u0627\u0644\u0643\u064a\u0645\u064a\u0627\u0621 \u0648\u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0648\u0627\u0644\u0636\u0648\u0627\u0628\u0637 (CMC) \u0641\u064a \u0648\u0642\u062a \u0627\u0644\u062a\u0642\u062f\u064a\u0645.<\/p>\n\n\n\n

\u0642\u0627\u0644\u062a \u0633\u0627\u0631\u0629 \u0628\u0648\u064a\u0633\u060c \u0627\u0644\u0631\u0626\u064a\u0633\u0629 \u0648\u0627\u0644\u0645\u062f\u064a\u0631\u0629 \u0627\u0644\u062a\u0646\u0641\u064a\u0630\u064a\u0629 \u0644\u0640 Avidity Biosciences: "\u0643\u0627\u0646 \u0627\u062c\u062a\u0645\u0627\u0639\u0646\u0627 \u0627\u0644\u0623\u062e\u064a\u0631 \u0645\u0639 FDA \u062a\u0639\u0627\u0648\u0646\u064a\u064b\u0627 \u0644\u0644\u063a\u0627\u064a\u0629\u060c \u0648\u0631\u0633\u0645 \u0645\u0633\u0627\u0631\u064b\u0627 \u0648\u0627\u0636\u062d\u064b\u0627 \u0644\u0644\u0645\u0636\u064a \u0642\u062f\u0645\u064b\u0627 \u0641\u064a \u062a\u0642\u062f\u064a\u0645 \u0637\u0644\u0628 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a". \u0648\u0623\u0636\u0627\u0641\u062a: "\u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0640 DMD\u060c \u064a\u064f\u0639\u062f \u0645\u0633\u0627\u0631 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0627\u0644\u0645\u064f\u0639\u062c\u0651\u0644 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629 \u0623\u0641\u0636\u0644 \u0648\u0623\u0633\u0631\u0639 \u0637\u0631\u064a\u0642\u0629 \u0644\u062a\u0648\u0641\u064a\u0631 del-zota \u0644\u0645\u0646 \u064a\u062d\u062a\u0627\u062c\u0648\u0646\u0647. \u0646\u062d\u0646 \u0645\u0645\u062a\u0646\u0648\u0646 \u0644\u0644\u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u062a\u064a \u0642\u062f\u0645\u062a \u0644\u0646\u0627 \u0625\u0631\u0634\u0627\u062f\u0627\u062a \u0648\u0627\u0636\u062d\u0629 \u062d\u0648\u0644 \u0628\u064a\u0627\u0646\u0627\u062a CMC \u0627\u0644\u062a\u064a \u062a\u062d\u062a\u0627\u062c\u0647\u0627 \u0639\u0646\u062f \u0627\u0644\u062a\u0642\u062f\u064a\u0645\u060c \u0648\u0646\u0639\u062a\u0642\u062f \u0623\u0646 \u0647\u0630\u0627 \u0627\u0644\u062a\u0648\u0627\u0641\u0642 \u0633\u064a\u064f\u0633\u0647\u0651\u0644 \u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u0646\u0627\u062c\u062d\u0629. \u0646\u064f\u0642\u062f\u0651\u0631 \u0628\u0634\u062f\u0629 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u064a\u0646 \u0627\u0644\u0645\u064f\u062e\u0644\u0635\u064a\u0646 \u0648\u0627\u0644\u062f\u0624\u0648\u0628\u064a\u0646 \u0645\u0646 \u0645\u062e\u062a\u0644\u0641 \u0627\u0644\u0623\u0642\u0633\u0627\u0645 \u062f\u0627\u062e\u0644 FDA \u0627\u0644\u0630\u064a\u0646 \u064a\u064f\u0645\u0643\u0651\u0646\u0648\u0646\u0646\u0627 \u0645\u0646 \u0627\u0644\u0645\u0636\u064a \u0642\u062f\u0645\u064b\u0627 \u0628\u0647\u0630\u0627 \u0627\u0644\u0628\u0631\u0646\u0627\u0645\u062c \u0628\u0627\u0644\u0633\u0631\u0639\u0629 \u0627\u0644\u062a\u064a \u064a\u0633\u062a\u062d\u0642\u0647\u0627. \u0646\u062d\u0646 \u0646\u064f\u062f\u0631\u0643 \u0623\u0647\u0645\u064a\u0629 \u0643\u0644 \u062f\u0642\u064a\u0642\u0629 \u0644\u0644\u0641\u062a\u064a\u0627\u0646 \u0648\u0627\u0644\u0634\u0628\u0627\u0628 \u0627\u0644\u0630\u064a\u0646 \u064a\u064f\u0639\u0627\u0646\u0648\u0646 \u0645\u0646 DMD".<\/p>\n\n\n\n

\u0644\u0627 \u062a\u0632\u0627\u0644 \u0634\u0631\u0643\u0629 \u0623\u0641\u064a\u062f\u064a\u062a\u064a \u0648\u0627\u062b\u0642\u0629 \u062a\u0645\u0627\u0645\u064b\u0627 \u0645\u0646 \u0625\u0645\u0643\u0627\u0646\u0627\u062a del-zota\u060c \u0648\u062a\u062a\u0637\u0644\u0639 \u0625\u0644\u0649 \u062a\u0642\u062f\u064a\u0645 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u0644\u0645\u0646\u062a\u062c del-zota \u0641\u064a \u0627\u0644\u0631\u0628\u0639 \u0627\u0644\u0623\u0648\u0644 \u0645\u0646 \u0639\u0627\u0645 2026\u060c \u0648\u0627\u0644\u0630\u064a \u0633\u064a\u0643\u0648\u0646 \u0627\u0644\u0623\u0648\u0644 \u0645\u0646 \u0628\u064a\u0646 \u062b\u0644\u0627\u062b\u0629 \u0637\u0644\u0628\u0627\u062a \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u0645\u062e\u0637\u0637 \u0644\u0647\u0627 \u062e\u0644\u0627\u0644 \u0641\u062a\u0631\u0629 12 \u0634\u0647\u0631\u064b\u0627. \u0628\u0627\u0644\u0625\u0636\u0627\u0641\u0629 \u0625\u0644\u0649 \u0630\u0644\u0643\u060c \u062a\u0648\u0627\u0635\u0644 \u0623\u0641\u064a\u062f\u064a\u062a\u064a \u0625\u0639\u062f\u0627\u062f \u062f\u0631\u0627\u0633\u0629 \u062a\u0623\u0643\u064a\u062f\u064a\u0629 \u0644\u062f\u0639\u0645 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0627\u0644\u0639\u0627\u0644\u0645\u064a\u0629 \u0627\u0644\u0643\u0627\u0645\u0644\u0629 \u0639\u0644\u0649 del-zota.<\/p>\n\n\n\n

\u0627\u0642\u0631\u0623 \u0627\u0644\u0645\u0632\u064a\u062f<\/strong>:\u00a0\u0627\u0644\u062a\u062c\u0627\u0631\u0628 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0644\u0645\u0631\u0636 \u062f\u0648\u0634\u064a\u0646 (\u0642\u0627\u0626\u0645\u0629 \u0628\u062c\u0645\u064a\u0639 \u0627\u0644\u0623\u0628\u062d\u0627\u062b)<\/a><\/p>","protected":false},"excerpt":{"rendered":"

Avidity Biosciences announced that the Company completed a positive pre-BLA meeting with the U.S. Food and Drug Administration (FDA) regarding its upcoming BLA submission of delpacibart zotadirsen (del-zota). Del-zota, which received Breakthrough Therapy designation, is an investigational drug being evaluated as a potential treatment for people living with Duchenne muscular dystrophy who have gene mutations […]<\/p>\n","protected":false},"author":1,"featured_media":4796,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[126,298,397,129,141,127,246,88],"class_list":["post-4794","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-avidity-biosciences","tag-del-zota","tag-delpacibart-zotadirsen","tag-dmd44","tag-exon-44","tag-exon-44-skipping","tag-exon-44-skipping-therapies","tag-fda"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/4794","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/comments?post=4794"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/4794\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media\/4796"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media?parent=4794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/categories?post=4794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/tags?post=4794"}],"curies":[{"name":"\u0648\u0648\u0631\u062f\u0628\u0631\u064a\u0633","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}