{"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\/hi\/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":"Avidity Biosciences \u0928\u0947 DMD44 \u092e\u0947\u0902 del-zota \u0915\u0947 \u0932\u093f\u090f US FDA \u0915\u0947 \u0938\u093e\u0925 \u0938\u0915\u093e\u0930\u093e\u0924\u094d\u092e\u0915 \u092a\u094d\u0930\u0940-BLA \u092c\u0948\u0920\u0915 \u0915\u0940 \u0918\u094b\u0937\u0923\u093e \u0915\u0940, \u091c\u093f\u0938\u0915\u093e \u0938\u092c\u092e\u093f\u0936\u0928 2026 \u0915\u0940 \u092a\u0939\u0932\u0940 \u0924\u093f\u092e\u093e\u0939\u0940 \u092e\u0947\u0902 \u0915\u0930\u0928\u0947 \u0915\u0940 \u092f\u094b\u091c\u0928\u093e \u0939\u0948\u0964"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Avidity Biosciences \u0928\u0947 \u0918\u094b\u0937\u0923\u093e \u0915\u0940 \u0939\u0948 \u0915\u093f \u0915\u0902\u092a\u0928\u0940 \u0928\u0947 \u0921\u0947\u0932\u094d\u092a\u0947\u0938\u093f\u092c\u093e\u0930\u094d\u091f \u091c\u093c\u094b\u091f\u093e\u0921\u093f\u0930\u0938\u0947\u0928 (del-zota) \u0915\u0947 \u0905\u092a\u0928\u0947 \u0906\u0917\u093e\u092e\u0940 BLA \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u0940\u0915\u0930\u0923 \u0915\u0947 \u0938\u0902\u092c\u0902\u0927 \u092e\u0947\u0902 \u0905\u092e\u0947\u0930\u093f\u0915\u0940 \u0916\u093e\u0926\u094d\u092f \u090f\u0935\u0902 \u0914\u0937\u0927\u093f \u092a\u094d\u0930\u0936\u093e\u0938\u0928 (FDA) \u0915\u0947 \u0938\u093e\u0925 \u090f\u0915 \u0938\u0915\u093e\u0930\u093e\u0924\u094d\u092e\u0915 \u092a\u0942\u0930\u094d\u0935-BLA \u092c\u0948\u0920\u0915 \u092a\u0942\u0930\u0940 \u0915\u0930 \u0932\u0940 \u0939\u0948\u0964 \u092c\u094d\u0930\u0947\u0915\u0925\u094d\u0930\u0942 \u0925\u0947\u0930\u0947\u092a\u0940 \u092a\u0926\u0928\u093e\u092e \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0921\u0947\u0932-\u091c\u093c\u094b\u091f\u093e \u090f\u0915 \u0936\u094b\u0927\u092a\u0930\u0915 \u0926\u0935\u093e \u0939\u0948 \u091c\u093f\u0938\u0915\u093e \u092e\u0942\u0932\u094d\u092f\u093e\u0902\u0915\u0928 \u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 \u0938\u0947 \u092a\u0940\u0921\u093c\u093f\u0924 \u0909\u0928 \u0932\u094b\u0917\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u090f\u0915 \u0938\u0902\u092d\u093e\u0935\u093f\u0924 \u0909\u092a\u091a\u093e\u0930 \u0915\u0947 \u0930\u0942\u092a \u092e\u0947\u0902 \u0915\u093f\u092f\u093e \u091c\u093e \u0930\u0939\u093e \u0939\u0948 \u091c\u093f\u0928\u0915\u0947 \u091c\u0940\u0928 \u0909\u0924\u094d\u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928 \u090f\u0915\u094d\u0938\u0949\u0928 44 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 (DMD44) \u0915\u0947 \u0905\u0928\u0941\u0915\u0942\u0932 \u0939\u0948\u0902\u0964<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0914\u0930 \u0905\u0927\u093f\u0915 \u091c\u093e\u0928\u0947\u0902<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/hi\/mutations-and-deletions-amenable-to-exon-44-skipping-therapies-dmd\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u090f\u0915\u094d\u0938\u0949\u0928 44 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0925\u0947\u0930\u0947\u092a\u0940 \u0915\u0947 \u0905\u0928\u0941\u0915\u0942\u0932 \u0909\u0924\u094d\u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928 \u0914\u0930 \u0935\u093f\u0932\u094b\u092a\u0928<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u092c\u0940\u090f\u0932\u090f \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0938\u092e\u092f \u0915\u094b \u0935\u0930\u094d\u0937 2025 \u0915\u0947 \u0905\u0902\u0924 \u0915\u0947 \u092a\u093f\u091b\u0932\u0947 \u092e\u093e\u0930\u094d\u0917\u0926\u0930\u094d\u0936\u0928 \u0938\u0947 Q1 2026 \u0924\u0915 \u0905\u0926\u094d\u092f\u0924\u0928 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948 \u0924\u093e\u0915\u093f \u092f\u0939 \u0938\u0941\u0928\u093f\u0936\u094d\u091a\u093f\u0924 \u0915\u093f\u092f\u093e \u091c\u093e \u0938\u0915\u0947 \u0915\u093f FDA \u0915\u094b \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0938\u092e\u092f \u0930\u0938\u093e\u092f\u0928 \u0935\u093f\u091c\u094d\u091e\u093e\u0928, \u0935\u093f\u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u0914\u0930 \u0928\u093f\u092f\u0902\u0924\u094d\u0930\u0923 (\u0938\u0940\u090f\u092e\u0938\u0940) \u092a\u0948\u0915\u0947\u091c \u0915\u093e \u0938\u092e\u0930\u094d\u0925\u0928 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u0905\u0924\u093f\u0930\u093f\u0915\u094d\u0924 \u0921\u0947\u091f\u093e \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0939\u094b\u0964<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Avidity Biosciences \u0915\u0940 \u0905\u0927\u094d\u092f\u0915\u094d\u0937 \u0914\u0930 \u0938\u0940\u0908\u0913 \u0938\u093e\u0930\u093e \u092c\u0949\u092f\u0938 \u0928\u0947 \u0915\u0939\u093e, &quot;FDA \u0915\u0947 \u0938\u093e\u0925 \u0939\u092e\u093e\u0930\u0940 \u0939\u093e\u0932\u093f\u092f\u093e \u092c\u0948\u0920\u0915 \u092c\u0947\u0939\u0926 \u0938\u0939\u092f\u094b\u0917\u093e\u0924\u094d\u092e\u0915 \u0930\u0939\u0940 \u0914\u0930 \u0907\u0938\u0928\u0947 \u0939\u092e\u093e\u0930\u0947 BLA \u0938\u092c\u092e\u093f\u0936\u0928 \u0915\u0947 \u0932\u093f\u090f \u090f\u0915 \u0938\u094d\u092a\u0937\u094d\u091f \u092e\u093e\u0930\u094d\u0917 \u092a\u094d\u0930\u0936\u0938\u094d\u0924 \u0915\u093f\u092f\u093e\u0964&quot; &quot;DMD \u0915\u0947 \u0932\u093f\u090f, \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u0924\u094d\u0935\u0930\u093f\u0924 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092e\u093e\u0930\u094d\u0917, del-zota \u0915\u094b \u091c\u093c\u0930\u0942\u0930\u0924\u092e\u0902\u0926 \u0932\u094b\u0917\u094b\u0902 \u0924\u0915 \u092a\u0939\u0941\u0901\u091a\u093e\u0928\u0947 \u0915\u093e \u0938\u092c\u0938\u0947 \u0905\u091a\u094d\u091b\u093e \u0914\u0930 \u0924\u0947\u091c\u093c \u0924\u0930\u0940\u0915\u093e \u0939\u0948\u0964 \u0939\u092e \u0906\u092d\u093e\u0930\u0940 \u0939\u0948\u0902 \u0915\u093f \u090f\u091c\u0947\u0902\u0938\u0940 \u0928\u0947 \u0938\u092c\u092e\u093f\u0936\u0928 \u0915\u0947 \u0938\u092e\u092f \u0939\u092e\u0947\u0902 \u0906\u0935\u0936\u094d\u092f\u0915 CMC \u0921\u0947\u091f\u093e \u0915\u0947 \u092c\u093e\u0930\u0947 \u092e\u0947\u0902 \u0938\u094d\u092a\u0937\u094d\u091f \u092e\u093e\u0930\u094d\u0917\u0926\u0930\u094d\u0936\u0928 \u0926\u093f\u092f\u093e, \u0914\u0930 \u0939\u092e\u093e\u0930\u093e \u092e\u093e\u0928\u0928\u093e \u0939\u0948 \u0915\u093f \u092f\u0939 \u0938\u0902\u0930\u0947\u0916\u0923 \u090f\u0915 \u0938\u092b\u0932 BLA \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0915\u094b \u0938\u0941\u0917\u092e \u092c\u0928\u093e \u0938\u0915\u0924\u093e \u0939\u0948\u0964 \u0939\u092e FDA \u0915\u0947 \u0935\u093f\u092d\u093f\u0928\u094d\u0928 \u0935\u093f\u092d\u093e\u0917\u094b\u0902 \u0915\u0947 \u0938\u092e\u0930\u094d\u092a\u093f\u0924, \u092e\u0947\u0939\u0928\u0924\u0940 \u0938\u092e\u0940\u0915\u094d\u0937\u0915\u094b\u0902 \u0915\u0947 \u092c\u0939\u0941\u0924 \u0906\u092d\u093e\u0930\u0940 \u0939\u0948\u0902 \u091c\u094b \u0939\u092e\u0947\u0902 \u0907\u0938 \u0915\u093e\u0930\u094d\u092f\u0915\u094d\u0930\u092e \u0915\u094b \u0909\u0938 \u0924\u0924\u094d\u092a\u0930\u0924\u093e \u0915\u0947 \u0938\u093e\u0925 \u0906\u0917\u0947 \u092c\u0922\u093c\u093e\u0928\u0947 \u092e\u0947\u0902 \u0938\u0915\u094d\u0937\u092e \u092c\u0928\u093e \u0930\u0939\u0947 \u0939\u0948\u0902 \u091c\u093f\u0938\u0915\u0940 \u092f\u0939 \u0939\u0915\u0926\u093e\u0930 \u0939\u0948\u0964 \u0939\u092e \u091c\u093e\u0928\u0924\u0947 \u0939\u0948\u0902 \u0915\u093f DMD \u0938\u0947 \u092a\u0940\u0921\u093c\u093f\u0924 \u0932\u0921\u093c\u0915\u094b\u0902 \u0914\u0930 \u092f\u0941\u0935\u093e\u0913\u0902 \u0915\u0947 \u0932\u093f\u090f \u0939\u0930 \u092a\u0932 \u092e\u093e\u092f\u0928\u0947 \u0930\u0916\u0924\u093e \u0939\u0948\u0964&quot;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u090f\u0935\u093f\u0921\u093f\u091f\u0940 \u0915\u094b del-zota \u0915\u0940 \u0915\u094d\u0937\u092e\u0924\u093e \u092a\u0930 \u092a\u0942\u0930\u093e \u092d\u0930\u094b\u0938\u093e \u0939\u0948 \u0914\u0930 \u0935\u0939 2026 \u0915\u0940 \u092a\u0939\u0932\u0940 \u0924\u093f\u092e\u093e\u0939\u0940 \u092e\u0947\u0902 del-zota \u0915\u0947 \u0932\u093f\u090f BLA \u0926\u093e\u0916\u093f\u0932 \u0915\u0930\u0928\u0947 \u0915\u0940 \u0909\u092e\u094d\u092e\u0940\u0926 \u0915\u0930 \u0930\u0939\u0940 \u0939\u0948, \u091c\u094b 12 \u092e\u0939\u0940\u0928\u0947 \u0915\u0940 \u0905\u0935\u0927\u093f \u092e\u0947\u0902 \u0915\u0902\u092a\u0928\u0940 \u0926\u094d\u0935\u093e\u0930\u093e \u0928\u093f\u092f\u094b\u091c\u093f\u0924 \u0924\u0940\u0928 BLA \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f\u092f\u094b\u0902 \u092e\u0947\u0902 \u0938\u0947 \u092a\u0939\u0932\u093e \u0939\u094b\u0917\u093e\u0964 \u0907\u0938\u0915\u0947 \u0905\u0924\u093f\u0930\u093f\u0915\u094d\u0924, \u090f\u0935\u093f\u0921\u093f\u091f\u0940 del-zota \u0915\u0940 \u092a\u0942\u0930\u094d\u0923 \u0935\u0948\u0936\u094d\u0935\u093f\u0915 \u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u0915\u0947 \u0938\u092e\u0930\u094d\u0925\u0928 \u092e\u0947\u0902 \u090f\u0915 \u092a\u0941\u0937\u094d\u091f\u093f\u0915\u0930\u0923 \u0905\u0927\u094d\u092f\u092f\u0928 \u0924\u0948\u092f\u093e\u0930 \u0915\u0930\u0928\u093e \u091c\u093e\u0930\u0940 \u0930\u0916\u0947 \u0939\u0941\u090f \u0939\u0948\u0964<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0914\u0930 \u092a\u0922\u093c\u0947\u0902<\/strong>:\u00a0<a href=\"https:\/\/dmdwarrior.com\/hi\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u0915\u0947 \u0932\u093f\u090f \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u092a\u0930\u0940\u0915\u094d\u0937\u0923 (\u0938\u092d\u0940 \u0936\u094b\u0927\u094b\u0902 \u0915\u0940 \u0938\u0942\u091a\u0940)<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>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 [&hellip;]<\/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"],"subtitle":"Avidity Biosciences \u0928\u0947 FDA \u0915\u0947 \u0938\u093e\u0925 delpacibart zotadirsen \u0915\u0940 \u0928\u093f\u0930\u094d\u0927\u093e\u0930\u093f\u0924 BLA \u092b\u093e\u0907\u0932\u093f\u0902\u0917 \u0915\u0947 \u092c\u093e\u0930\u0947 \u092e\u0947\u0902 \u0938\u092b\u0932 \u092a\u0942\u0930\u094d\u0935-BLA \u092c\u0948\u0920\u0915 \u0915\u0940 \u0938\u0942\u091a\u0928\u093e \u0926\u0940\u0964","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/4794","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/comments?post=4794"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/4794\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media\/4796"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media?parent=4794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/categories?post=4794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/tags?post=4794"}],"curies":[{"name":"\u0921\u092c\u094d\u0932\u094d\u092f\u0942\u092a\u0940","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}