{"id":8259,"date":"2026-07-20T15:10:42","date_gmt":"2026-07-20T12:10:42","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=8259"},"modified":"2026-07-20T15:30:25","modified_gmt":"2026-07-20T12:30:25","slug":"z-rostudirsen-fda-bla-accepted","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/hi\/z-rostudirsen-fda-bla-accepted\/","title":{"rendered":"Dyne Therapeutics \u0928\u0947 \u0918\u094b\u0937\u0923\u093e \u0915\u0940 \u0915\u093f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 FDA \u0926\u094d\u0935\u093e\u0930\u093e \u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 (DMD) \u0915\u0947 \u0932\u093f\u090f \u090f\u0915\u094d\u0938\u0949\u0928 51 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0925\u0947\u0930\u0947\u092a\u0940, Z-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 \u0915\u0947 \u0932\u093f\u090f \u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u090f\u092a\u094d\u0932\u0940\u0915\u0947\u0936\u0928 (BLA) \u0915\u094b \u0938\u094d\u0935\u0940\u0915\u093e\u0930 \u0915\u0930 \u0932\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948\u0964"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>\u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 (\u0921\u0940\u090f\u092e\u0921\u0940) \u0938\u0947 \u092a\u094d\u0930\u092d\u093e\u0935\u093f\u0924 \u092a\u0930\u093f\u0935\u093e\u0930\u094b\u0902 \u0915\u094b \u0909\u0924\u094d\u0938\u093e\u0939\u091c\u0928\u0915 \u0916\u092c\u0930 \u092e\u093f\u0932\u0940 \u0915\u094d\u092f\u094b\u0902\u0915\u093f 1\u091f\u0940\u092a\u094046\u091f\u0940 \u0928\u0947 \u0918\u094b\u0937\u0923\u093e \u0915\u0940 \u0915\u093f \u0905\u092e\u0947\u0930\u093f\u0915\u0940 \u0916\u093e\u0926\u094d\u092f \u0914\u0930 \u0914\u0937\u0927\u093f \u092a\u094d\u0930\u0936\u093e\u0938\u0928 (1\u091f\u0940\u092a\u0940167\u091f\u0940) \u0928\u0947 \u091c\u0947\u0921-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 (\u092a\u0942\u0930\u094d\u0935 \u092e\u0947\u0902 1\u091f\u0940\u092a\u0940122\u091f\u0940) \u0915\u0947 \u0932\u093f\u090f \u0909\u0938\u0915\u0947 \u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 (\u092c\u0940\u090f\u0932\u090f) \u0915\u094b \u0938\u094d\u0935\u0940\u0915\u093e\u0930 \u0915\u0930 \u0932\u093f\u092f\u093e \u0939\u0948\u0964.<\/strong> \u092f\u0939 \u092a\u094d\u0930\u093e\u092f\u094b\u0917\u093f\u0915 \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u093e \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 \u0935\u093f\u0915\u0938\u093f\u0924 \u0915\u0940 \u091c\u093e \u0930\u0939\u0940 \u0939\u0948 \u091c\u094b \u090f\u0915\u094d\u0938\u0949\u0928 51 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u092f\u0941\u0915\u094d\u0924 \u0939\u0948\u0902\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u0915\u094b \u092a\u094d\u0930\u093e\u0925\u092e\u093f\u0915\u0924\u093e \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092d\u0940 \u092a\u094d\u0930\u0926\u093e\u0928 \u0915\u0940 \u0917\u0908 \u0939\u0948, \u091c\u093f\u0938\u0938\u0947 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0915\u0940 \u0938\u092e\u092f\u0938\u0940\u092e\u093e \u0915\u092e \u0939\u094b \u0917\u0908 \u0939\u0948 \u0914\u0930 \u092a\u094d\u0930\u093f\u0938\u094d\u0915\u094d\u0930\u093f\u092a\u094d\u0936\u0928 \u0921\u094d\u0930\u0917 \u092f\u0942\u091c\u0930 \u092b\u0940 \u090f\u0915\u094d\u091f (PDUFA) \u0915\u0947 \u0924\u0939\u0924 \u0915\u093e\u0930\u094d\u0930\u0935\u093e\u0908 \u0915\u0940 \u0932\u0915\u094d\u0937\u093f\u0924 \u0924\u093f\u0925\u093f 21 \u091c\u0928\u0935\u0930\u0940, 2027 \u0928\u093f\u0930\u094d\u0927\u093e\u0930\u093f\u0924 \u0915\u0940 \u0917\u0908 \u0939\u0948\u0964 \u092f\u0926\u093f \u092e\u0902\u091c\u0942\u0930\u0940 \u092e\u093f\u0932 \u091c\u093e\u0924\u0940 \u0939\u0948, \u0924\u094b \u0921\u093e\u092f\u0928 \u0915\u094b \u0909\u092e\u094d\u092e\u0940\u0926 \u0939\u0948 \u0915\u093f \u0935\u0939 2027 \u0915\u0940 \u092a\u0939\u0932\u0940 \u0924\u093f\u092e\u093e\u0939\u0940 \u0915\u0947 \u0926\u094c\u0930\u093e\u0928 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u091c\u0947\u0921-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 \u0932\u0949\u0928\u094d\u091a \u0915\u0930\u0947\u0917\u0940\u0964.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0935\u093f\u0937\u092f\u0938\u0942\u091a\u0940<\/h2><nav><ul><li><a href=\"#what-is-z-rostudirsen\">Z-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 \u0915\u094d\u092f\u093e \u0939\u0948?<\/a><\/li><li><a href=\"#fda-accepts-biologics-license-application\">FDA \u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 \u0938\u094d\u0935\u0940\u0915\u093e\u0930 \u0915\u0930\u0924\u093e \u0939\u0948<\/a><\/li><li><a href=\"#why-is-accelerated-approval-important\">\u0924\u094d\u0935\u0930\u093f\u0924 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u094d\u092f\u094b\u0902 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0939\u0948?<\/a><\/li><li><a href=\"#deliver-trial-results\">DELIVER \u092a\u0930\u0940\u0915\u094d\u0937\u0923 \u0915\u0947 \u092a\u0930\u093f\u0923\u093e\u092e<\/a><\/li><li><a href=\"#dyne-therapeutics-plans-u-s-launch-in-early-2027\">Dyne Therapeutics \u0915\u094b 2027 \u0915\u0940 \u0936\u0941\u0930\u0941\u0906\u0924 \u092e\u0947\u0902 \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u0932\u0949\u0928\u094d\u091a \u0915\u0930\u0928\u0947 \u0915\u0940 \u092f\u094b\u091c\u0928\u093e \u0939\u0948\u0964<\/a><\/li><li><a href=\"#dynes-broader-duchenne-pipeline\">\u0921\u093e\u0907\u0928 \u0915\u0940 \u0935\u094d\u092f\u093e\u092a\u0915 \u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092a\u093e\u0907\u092a\u0932\u093e\u0907\u0928<\/a><\/li><li><a href=\"#what-this-means-for-the-duchenne-community\">\u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u0938\u092e\u0941\u0926\u093e\u092f \u0915\u0947 \u0932\u093f\u090f \u0907\u0938\u0915\u093e \u0915\u094d\u092f\u093e \u0905\u0930\u094d\u0925 \u0939\u0948?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 id=\"what-is-z-rostudirsen\" class=\"wp-block-heading\">Z-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 \u0915\u094d\u092f\u093e \u0939\u0948?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u091c\u0947\u0921-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 (\u091c\u093f\u0938\u0947 \u092a\u0939\u0932\u0947 1\u091f\u0940\u092a\u0940122\u091f\u0940 \u0915\u0947 \u0928\u093e\u092e \u0938\u0947 \u091c\u093e\u0928\u093e \u091c\u093e\u0924\u093e \u0925\u093e) \u090f\u0915 \u092a\u094d\u0930\u093e\u092f\u094b\u0917\u093f\u0915 \u090f\u0915\u094d\u0938\u0949\u0928 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0925\u0947\u0930\u0947\u092a\u0940 \u0939\u0948 \u091c\u093f\u0938\u0947 \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 \u0935\u094d\u092f\u0915\u094d\u0924\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u0921\u093f\u091c\u093c\u093e\u0907\u0928 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948, \u091c\u094b \u0909\u0928 \u0909\u0924\u094d\u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928\u094b\u0902 \u0915\u0947 \u0915\u093e\u0930\u0923 \u0939\u094b\u0924\u093e \u0939\u0948 \u091c\u094b \u090f\u0915\u094d\u0938\u0949\u0928 51 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u092f\u0941\u0915\u094d\u0924 \u0939\u0948\u0902\u0964.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0907\u0938 \u0925\u0947\u0930\u0947\u092a\u0940 \u092e\u0947\u0902 Dyne Therapeutics \u0915\u093e \u092e\u093e\u0932\u093f\u0915\u093e\u0928\u093e \u0939\u0915 \u092a\u094d\u0930\u093e\u092a\u094d\u0924 FORCE\u2122 \u092a\u094d\u0932\u0947\u091f\u092b\u0949\u0930\u094d\u092e \u0907\u0938\u094d\u0924\u0947\u092e\u093e\u0932 \u0915\u093f\u092f\u093e \u091c\u093e\u0924\u093e \u0939\u0948, \u091c\u093f\u0938\u0947 \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u0940\u092f \u0905\u0923\u0941\u0913\u0902 \u0915\u094b \u0938\u0940\u0927\u0947 \u0915\u0902\u0915\u093e\u0932 \u0914\u0930 \u0939\u0943\u0926\u092f \u0915\u0940 \u092e\u093e\u0902\u0938\u092a\u0947\u0936\u093f\u092f\u094b\u0902 \u0915\u0940 \u0915\u094b\u0936\u093f\u0915\u093e\u0913\u0902 \u0924\u0915 \u092a\u0939\u0941\u0902\u091a\u093e\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u0921\u093f\u091c\u093c\u093e\u0907\u0928 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948\u0964 \u092e\u093e\u0902\u0938\u092a\u0947\u0936\u093f\u092f\u094b\u0902 \u0915\u0947 \u090a\u0924\u0915\u094b\u0902 \u0924\u0915 \u092c\u0947\u0939\u0924\u0930 \u0924\u0930\u0940\u0915\u0947 \u0938\u0947 \u092a\u0939\u0941\u0902\u091a\u093e\u0915\u0930, \u0907\u0938 \u0909\u092a\u091a\u093e\u0930 \u0915\u093e \u0909\u0926\u094d\u0926\u0947\u0936\u094d\u092f \u0932\u0917\u092d\u0917 \u092a\u0942\u0930\u094d\u0923 \u0932\u0902\u092c\u093e\u0908 \u0935\u093e\u0932\u0947 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u092a\u094d\u0930\u094b\u091f\u0940\u0928 \u0915\u0947 \u0909\u0924\u094d\u092a\u093e\u0926\u0928 \u0915\u094b \u092c\u0922\u093c\u093e\u0928\u093e \u0939\u0948, \u091c\u094b \u0938\u094d\u0935\u0938\u094d\u0925 \u092e\u093e\u0902\u0938\u092a\u0947\u0936\u093f\u092f\u094b\u0902 \u0915\u0947 \u0915\u093e\u0930\u094d\u092f \u0915\u094b \u092c\u0928\u093e\u090f \u0930\u0916\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u0906\u0935\u0936\u094d\u092f\u0915 \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u092a\u093e\u0930\u0902\u092a\u0930\u093f\u0915 \u090f\u0915\u094d\u0938\u0949\u0928 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0925\u0947\u0930\u0947\u092a\u0940 \u0915\u0947 \u0935\u093f\u092a\u0930\u0940\u0924, \u091c\u093f\u0928\u092e\u0947\u0902 \u092e\u093e\u0902\u0938\u092a\u0947\u0936\u093f\u092f\u094b\u0902 \u0926\u094d\u0935\u093e\u0930\u093e \u0905\u0935\u0936\u094b\u0937\u0923 \u0938\u0940\u092e\u093f\u0924 \u0939\u094b \u0938\u0915\u0924\u093e \u0939\u0948, \u091c\u0947\u0921-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 \u0915\u094b \u0935\u093f\u0936\u0947\u0937 \u0930\u0942\u092a \u0938\u0947 \u092c\u0947\u0939\u0924\u0930 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u094b\u092b\u093c\u093e\u0907\u0932 \u092c\u0928\u093e\u090f \u0930\u0916\u0924\u0947 \u0939\u0941\u090f \u090a\u0924\u0915 \u0935\u093f\u0924\u0930\u0923 \u0915\u094b \u092c\u0947\u0939\u0924\u0930 \u092c\u0928\u093e\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u0907\u0902\u091c\u0940\u0928\u093f\u092f\u0930 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0925\u093e\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-51-skipping-therapies-dmd\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u090f\u0915\u094d\u0938\u0949\u0928 51 \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<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 id=\"fda-accepts-biologics-license-application\" class=\"wp-block-heading\">FDA \u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 \u0938\u094d\u0935\u0940\u0915\u093e\u0930 \u0915\u0930\u0924\u093e \u0939\u0948<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u0926\u094d\u0935\u093e\u0930\u093e \u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u090f\u092a\u094d\u0932\u0940\u0915\u0947\u0936\u0928 (BLA) \u0915\u0940 \u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u0915\u093e \u0905\u0930\u094d\u0925 \u0939\u0948 \u0915\u093f \u090f\u091c\u0947\u0902\u0938\u0940 \u0928\u0947 \u092f\u0939 \u0928\u093f\u0930\u094d\u0927\u093e\u0930\u093f\u0924 \u0915\u0930 \u0932\u093f\u092f\u093e \u0939\u0948 \u0915\u093f \u0906\u0935\u0947\u0926\u0928 \u0914\u092a\u091a\u093e\u0930\u093f\u0915 \u0935\u0948\u091c\u094d\u091e\u093e\u0928\u093f\u0915 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0936\u0941\u0930\u0942 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u092a\u0930\u094d\u092f\u093e\u092a\u094d\u0924 \u0930\u0942\u092a \u0938\u0947 \u092a\u0942\u0930\u094d\u0923 \u0939\u0948\u0964 \u0914\u0930 \u092a\u0922\u093c\u0947\u0902: <a href=\"https:\/\/dmdwarrior.com\/hi\/biologics-license-application-bla\/\" target=\"_blank\" data-type=\"post\" data-id=\"5027\" rel=\"noreferrer noopener\">\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 (\u092c\u0940\u090f\u0932\u090f)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0907\u0938 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0915\u0947 \u092d\u093e\u0917 \u0915\u0947 \u0930\u0942\u092a \u092e\u0947\u0902:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>FDA \u0928\u0947 \u092a\u094d\u0930\u093e\u0925\u092e\u093f\u0915\u0924\u093e \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u0926\u093e\u0928 \u0915\u0940, \u091c\u093f\u0938\u0938\u0947 \u092e\u093e\u0928\u0915 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0905\u0935\u0927\u093f \u0915\u092e \u0939\u094b \u0917\u0908\u0964.<\/strong><\/li>\n\n\n\n<li>\u092a\u0940\u0921\u0940\u092f\u0942\u090f\u092b\u090f \u0915\u0947 \u0932\u093f\u090f \u0932\u0915\u094d\u0937\u093f\u0924 \u0915\u093e\u0930\u094d\u0930\u0935\u093e\u0908 \u0924\u093f\u0925\u093f 21 \u091c\u0928\u0935\u0930\u0940, 2027 \u0928\u093f\u0930\u094d\u0927\u093e\u0930\u093f\u0924 \u0915\u0940 \u0917\u0908 \u0939\u0948\u0964.<\/li>\n\n\n\n<li><strong>\u092f\u0939 \u0906\u0935\u0947\u0926\u0928 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0909\u0924\u094d\u092a\u093e\u0926\u0928 \u0915\u094b \u090f\u0915 \u0935\u0948\u0915\u0932\u094d\u092a\u093f\u0915 \u0932\u0915\u094d\u0937\u094d\u092f \u0915\u0947 \u0930\u0942\u092a \u092e\u0947\u0902 \u092e\u093e\u0928\u0924\u0947 \u0939\u0941\u090f \u0924\u094d\u0935\u0930\u093f\u0924 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u0940 \u092e\u093e\u0902\u0917 \u0915\u0930\u0924\u093e \u0939\u0948\u0964.<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u092f\u0926\u093f FDA \u0907\u0938 \u0928\u093f\u0937\u094d\u0915\u0930\u094d\u0937 \u092a\u0930 \u092a\u0939\u0941\u0901\u091a\u0924\u093e \u0939\u0948 \u0915\u093f \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0909\u0924\u094d\u092a\u093e\u0926\u0928 \u092e\u0947\u0902 \u0935\u0943\u0926\u094d\u0927\u093f \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0932\u093e\u092d \u0915\u0940 \u092d\u0935\u093f\u0937\u094d\u092f\u0935\u093e\u0923\u0940 \u0915\u0930\u0928\u0947 \u0915\u0940 \u0909\u091a\u093f\u0924 \u0938\u0902\u092d\u093e\u0935\u0928\u093e \u0939\u0948, \u0924\u094b \u091c\u093c\u0947\u0921-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 \u0915\u094b \u0924\u094d\u0935\u0930\u093f\u0924 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0939\u094b \u0938\u0915\u0924\u093e \u0939\u0948, \u091c\u092c\u0915\u093f \u0905\u0924\u093f\u0930\u093f\u0915\u094d\u0924 \u0905\u0927\u094d\u092f\u092f\u0928 \u0926\u0940\u0930\u094d\u0918\u0915\u093e\u0932\u093f\u0915 \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u092a\u0930\u093f\u0923\u093e\u092e\u094b\u0902 \u0915\u0940 \u092a\u0941\u0937\u094d\u091f\u093f \u0915\u0930\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u091c\u093e\u0930\u0940 \u0930\u0939\u0947\u0902\u0917\u0947\u0964.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 id=\"why-is-accelerated-approval-important\" class=\"wp-block-heading\">\u0924\u094d\u0935\u0930\u093f\u0924 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u094d\u092f\u094b\u0902 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0939\u0948?<\/h2>\n\n\n\n<h3 id=\"understanding-the-accelerated-approval-pathway\" class=\"wp-block-heading\">\u0924\u094d\u0935\u0930\u093f\u0924 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0915\u094b \u0938\u092e\u091d\u0928\u093e<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 \u091c\u0948\u0938\u0940 \u0926\u0941\u0930\u094d\u0932\u092d \u092c\u0940\u092e\u093e\u0930\u093f\u092f\u094b\u0902 \u0915\u0947 \u0907\u0932\u093e\u091c \u0935\u093f\u0915\u0938\u093f\u0924 \u0915\u0930\u0928\u0947 \u092e\u0947\u0902 \u0905\u0915\u094d\u0938\u0930 \u0915\u0908 \u0938\u093e\u0932 \u0932\u0917 \u091c\u093e\u0924\u0947 \u0939\u0948\u0902\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u094b \u0906\u0936\u093e\u091c\u0928\u0915 \u0909\u092a\u091a\u093e\u0930\u094b\u0902 \u0924\u0915 \u0936\u0940\u0918\u094d\u0930 \u092a\u0939\u0941\u0902\u091a \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0915\u0930\u0928\u0947 \u092e\u0947\u0902 \u0938\u0939\u093e\u092f\u0924\u093e \u0915\u0947 \u0932\u093f\u090f, FDA \u0928\u0947 \u0924\u094d\u0935\u0930\u093f\u0924 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092e\u093e\u0930\u094d\u0917 \u092c\u0928\u093e\u092f\u093e\u0964 \u092f\u0939 \u0928\u093f\u092f\u093e\u092e\u0915 \u092e\u093e\u0930\u094d\u0917 \u090f\u0915 \u0910\u0938\u0947 \u0935\u0948\u0915\u0932\u094d\u092a\u093f\u0915 \u092a\u0930\u093f\u0923\u093e\u092e \u0915\u0947 \u0906\u0927\u093e\u0930 \u092a\u0930 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u0940 \u0905\u0928\u0941\u092e\u0924\u093f \u0926\u0947\u0924\u093e \u0939\u0948 \u091c\u094b \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0932\u093e\u092d \u0915\u0940 \u092d\u0935\u093f\u0937\u094d\u092f\u0935\u093e\u0923\u0940 \u0915\u0930\u0928\u0947 \u0915\u0940 \u0909\u091a\u093f\u0924 \u0938\u0902\u092d\u093e\u0935\u0928\u093e \u0930\u0916\u0924\u093e \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 \u0915\u0947 \u0932\u093f\u090f, \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0909\u0924\u094d\u092a\u093e\u0926\u0928 \u0928\u093f\u092f\u093e\u092e\u0915\u094b\u0902 \u0926\u094d\u0935\u093e\u0930\u093e \u092e\u0942\u0932\u094d\u092f\u093e\u0902\u0915\u0928 \u0915\u093f\u090f \u091c\u093e\u0928\u0947 \u0935\u093e\u0932\u0947 \u0938\u092c\u0938\u0947 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0938\u0930\u094b\u0917\u0947\u091f \u092c\u093e\u092f\u094b\u092e\u093e\u0930\u094d\u0915\u0930\u094b\u0902 \u092e\u0947\u0902 \u0938\u0947 \u090f\u0915 \u092c\u0928 \u0917\u092f\u093e \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0924\u094d\u0935\u0930\u093f\u0924 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0915\u0930\u0928\u0947 \u0935\u093e\u0932\u0940 \u0915\u0902\u092a\u0928\u093f\u092f\u094b\u0902 \u0915\u094b \u0906\u092e \u0924\u094c\u0930 \u092a\u0930 \u092f\u0939 \u092a\u0941\u0937\u094d\u091f\u093f \u0915\u0930\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u0935\u093f\u092a\u0923\u0928 \u0915\u0947 \u092c\u093e\u0926 \u0915\u0947 \u0905\u0927\u094d\u092f\u092f\u0928 \u091c\u093e\u0930\u0940 \u0930\u0916\u0928\u0947 \u0915\u0940 \u0906\u0935\u0936\u094d\u092f\u0915\u0924\u093e \u0939\u094b\u0924\u0940 \u0939\u0948 \u0915\u093f \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u094b \u0938\u093e\u0930\u094d\u0925\u0915 \u0926\u0940\u0930\u094d\u0918\u0915\u093e\u0932\u093f\u0915 \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0932\u093e\u092d \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0939\u094b \u0930\u0939\u0947 \u0939\u0948\u0902\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0939\u092e\u093e\u0930\u0947 \u091f\u0942\u0932 \u0915\u093e \u0905\u092d\u0940 \u0909\u092a\u092f\u094b\u0917 \u0915\u0930\u0947\u0902<\/strong>: <a href=\"https:\/\/dmdwarrior.com\/hi\/duchenne-exon-deletion-tool\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0921\u0940\u090f\u092e\u0921\u0940\/\u092c\u0940\u090f\u092e\u0921\u0940 \u090f\u0915\u094d\u0938\u0949\u0928 \u0935\u093f\u0936\u094d\u0932\u0947\u0937\u0923 \u0909\u092a\u0915\u0930\u0923<\/a><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 id=\"deliver-trial-results\" class=\"wp-block-heading\">DELIVER \u092a\u0930\u0940\u0915\u094d\u0937\u0923 \u0915\u0947 \u092a\u0930\u093f\u0923\u093e\u092e<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u092c\u0940\u090f\u0932\u090f \u0938\u092c\u092e\u093f\u0936\u0928 \u0915\u094b \u092b\u0947\u091c 1\/2 \u0921\u093f\u0932\u0940\u0935\u0930 \u0915\u094d\u0932\u093f\u0928\u093f\u0915\u0932 \u091f\u094d\u0930\u093e\u092f\u0932 \u0915\u0947 \u092a\u0902\u091c\u0940\u0915\u0930\u0923 \u0935\u093f\u0938\u094d\u0924\u093e\u0930 \u0938\u092e\u0942\u0939 \u0915\u0947 \u092a\u0930\u093f\u0923\u093e\u092e\u094b\u0902 \u0926\u094d\u0935\u093e\u0930\u093e \u0938\u092e\u0930\u094d\u0925\u093f\u0924 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dyne Therapeutics \u0915\u0947 \u0905\u0928\u0941\u0938\u093e\u0930, \u0939\u0930 \u091a\u093e\u0930 \u0938\u092a\u094d\u0924\u093e\u0939 \u092e\u0947\u0902 \u090f\u0915 \u092c\u093e\u0930 \u091c\u093c\u0947\u0921-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0915\u0930\u0928\u0947 \u0935\u093e\u0932\u0947 \u092a\u094d\u0930\u0924\u093f\u092d\u093e\u0917\u093f\u092f\u094b\u0902 \u0928\u0947 \u0928\u093f\u092e\u094d\u0928\u0932\u093f\u0916\u093f\u0924 \u092a\u094d\u0930\u0926\u0930\u094d\u0936\u093f\u0924 \u0915\u093f\u092f\u093e:<\/p>\n\n\n\n<h3 id=\"significant-increase-in-dystrophin\" class=\"wp-block-heading\">\u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u092e\u0947\u0902 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0935\u0943\u0926\u094d\u0927\u093f<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u092e\u0947\u0902 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0909\u0924\u094d\u092a\u093e\u0926\u0928 \u092e\u0947\u0902 \u090f\u0915 \u092e\u091c\u092c\u0942\u0924 \u0914\u0930 \u0938\u093e\u0902\u0916\u094d\u092f\u093f\u0915\u0940\u092f \u0930\u0942\u092a \u0938\u0947 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0935\u0943\u0926\u094d\u0927\u093f \u0926\u0947\u0916\u0940 \u0917\u0908, \u091c\u094b \u090f\u0915\u094d\u0938\u0949\u0928 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0925\u0947\u0930\u0947\u092a\u0940 \u0915\u0947 \u092a\u094d\u0930\u093e\u0925\u092e\u093f\u0915 \u091c\u0948\u0935\u093f\u0915 \u0909\u0926\u094d\u0926\u0947\u0936\u094d\u092f \u0915\u093e \u0938\u092e\u0930\u094d\u0925\u0928 \u0915\u0930\u0924\u0940 \u0939\u0948\u0964.<\/p>\n\n\n\n<h3 id=\"improvements-across-multiple-functional-measures\" class=\"wp-block-heading\">\u0915\u0908 \u0915\u093e\u0930\u094d\u092f\u093e\u0924\u094d\u092e\u0915 \u092e\u093e\u092a\u0926\u0902\u0921\u094b\u0902 \u092e\u0947\u0902 \u0938\u0941\u0927\u093e\u0930<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u092a\u094d\u0930\u092f\u094b\u0917\u0936\u093e\u0932\u093e \u0915\u0947 \u0928\u093f\u0937\u094d\u0915\u0930\u094d\u0937\u094b\u0902 \u0915\u0947 \u0905\u0932\u093e\u0935\u093e, \u0936\u094b\u0927\u0915\u0930\u094d\u0924\u093e\u0913\u0902 \u0928\u0947 \u0915\u0908 \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0915\u093e\u0930\u094d\u092f\u093e\u0924\u094d\u092e\u0915 \u092e\u093e\u092a\u0926\u0902\u0921\u094b\u0902 \u092e\u0947\u0902 \u092d\u0940 \u0938\u0941\u0927\u093e\u0930 \u0926\u0947\u0916\u093e, \u091c\u093f\u0938\u0938\u0947 \u092a\u0924\u093e \u091a\u0932\u0924\u093e \u0939\u0948 \u0915\u093f \u092c\u0922\u093c\u0947 \u0939\u0941\u090f \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0915\u093e \u092c\u0947\u0939\u0924\u0930 \u0936\u093e\u0930\u0940\u0930\u093f\u0915 \u092a\u094d\u0930\u0926\u0930\u094d\u0936\u0928 \u092e\u0947\u0902 \u092f\u094b\u0917\u0926\u093e\u0928 \u0939\u094b \u0938\u0915\u0924\u093e \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0939\u093e\u0932\u093e\u0902\u0915\u093f \u0905\u0924\u093f\u0930\u093f\u0915\u094d\u0924 \u0926\u0940\u0930\u094d\u0918\u0915\u093e\u0932\u093f\u0915 \u0905\u0927\u094d\u092f\u092f\u0928 \u0905\u092d\u0940 \u092d\u0940 \u091c\u093e\u0930\u0940 \u0939\u0948\u0902, \u0932\u0947\u0915\u093f\u0928 \u092f\u0947 \u0915\u093e\u0930\u094d\u092f\u093e\u0924\u094d\u092e\u0915 \u0928\u093f\u0937\u094d\u0915\u0930\u094d\u0937 \u0907\u0938 \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u093e \u092a\u0926\u094d\u0927\u0924\u093f \u0915\u093e \u0938\u092e\u0930\u094d\u0925\u0928 \u0915\u0930\u0928\u0947 \u0935\u093e\u0932\u0947 \u0938\u092e\u0917\u094d\u0930 \u092a\u094d\u0930\u092e\u093e\u0923\u094b\u0902 \u0915\u094b \u0914\u0930 \u092e\u091c\u092c\u0942\u0924 \u0915\u0930\u0924\u0947 \u0939\u0948\u0902\u0964.<\/p>\n\n\n\n<h3 id=\"favorable-safety-profile\" class=\"wp-block-heading\">\u0905\u0928\u0941\u0915\u0942\u0932 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u094b\u092b\u093c\u093e\u0907\u0932<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u0915\u0902\u092a\u0928\u0940 \u0928\u0947 \u090f\u0915 \u0905\u0928\u0941\u0915\u0942\u0932 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u094b\u092b\u093c\u093e\u0907\u0932 \u0915\u0940 \u092d\u0940 \u0930\u093f\u092a\u094b\u0930\u094d\u091f \u0926\u0940, \u091c\u093f\u0938\u092e\u0947\u0902 \u0905\u0927\u094d\u092f\u092f\u0928 \u0905\u0935\u0927\u093f \u0915\u0947 \u0926\u094c\u0930\u093e\u0928 \u0909\u092a\u091a\u093e\u0930 \u0915\u094b \u0906\u092e \u0924\u094c\u0930 \u092a\u0930 \u0905\u091a\u094d\u091b\u0940 \u0924\u0930\u0939 \u0938\u0947 \u0938\u0939\u0928 \u0915\u093f\u092f\u093e \u0917\u092f\u093e\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0915\u0947 \u0926\u094c\u0930\u093e\u0928 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u092e\u0941\u0916 \u0935\u093f\u091a\u093e\u0930\u0923\u0940\u092f \u092c\u093f\u0902\u0926\u0941\u0913\u0902 \u092e\u0947\u0902 \u0938\u0947 \u090f\u0915 \u092c\u0928\u0940 \u0939\u0941\u0908 \u0939\u0948\u0964.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 id=\"dyne-therapeutics-plans-u-s-launch-in-early-2027\" class=\"wp-block-heading\">Dyne Therapeutics \u0915\u094b 2027 \u0915\u0940 \u0936\u0941\u0930\u0941\u0906\u0924 \u092e\u0947\u0902 \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u0932\u0949\u0928\u094d\u091a \u0915\u0930\u0928\u0947 \u0915\u0940 \u092f\u094b\u091c\u0928\u093e \u0939\u0948\u0964<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u092f\u0926\u093f FDA \u0915\u094b \u0928\u093f\u0930\u094d\u0927\u093e\u0930\u093f\u0924 \u0938\u092e\u092f \u092a\u0930 \u092e\u0902\u091c\u0942\u0930\u0940 \u092e\u093f\u0932 \u091c\u093e\u0924\u0940 \u0939\u0948, \u0924\u094b Dyne Therapeutics \u0915\u094b \u0909\u092e\u094d\u092e\u0940\u0926 \u0939\u0948 \u0915\u093f \u0935\u0939 2027 \u0915\u0940 \u092a\u0939\u0932\u0940 \u0924\u093f\u092e\u093e\u0939\u0940 \u0915\u0947 \u0926\u094c\u0930\u093e\u0928 \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u091c\u0947\u0921-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928 \u0915\u094b \u0935\u094d\u092f\u093e\u0935\u0938\u093e\u092f\u093f\u0915 \u0930\u0942\u092a \u0938\u0947 \u0909\u092a\u0932\u092c\u094d\u0927 \u0915\u0930\u093e \u0926\u0947\u0917\u0940\u0964.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0915\u0902\u092a\u0928\u0940 \u0915\u0947 \u0905\u0927\u094d\u092f\u0915\u094d\u0937 \u0914\u0930 \u0938\u0940\u0908\u0913 \u091c\u0949\u0928 \u0915\u0949\u0915\u094d\u0938 \u0928\u0947 \u0915\u0939\u093e \u0915\u093f \u0932\u0915\u094d\u0937\u094d\u092f \u090f\u0915 \u0910\u0938\u0940 \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u093e \u092a\u094d\u0930\u0926\u093e\u0928 \u0915\u0930\u0928\u093e \u0939\u0948 \u091c\u094b \u0928\u093f\u092e\u094d\u0928\u0932\u093f\u0916\u093f\u0924 \u0932\u093e\u092d \u092a\u094d\u0930\u0926\u093e\u0928 \u0915\u0930\u0928\u0947 \u092e\u0947\u0902 \u0938\u0915\u094d\u0937\u092e \u0939\u094b:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0932\u0917\u092d\u0917 \u092a\u0942\u0930\u094d\u0923 \u0932\u0902\u092c\u093e\u0908 \u0935\u093e\u0932\u0947 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0915\u093e \u092e\u091c\u092c\u0942\u0924 \u0909\u0924\u094d\u092a\u093e\u0926\u0928<\/li>\n\n\n\n<li>\u0938\u0902\u092c\u0902\u0927\u093f\u0924 \u092e\u093e\u0902\u0938\u092a\u0947\u0936\u0940 \u090a\u0924\u0915\u094b\u0902 \u092e\u0947\u0902 \u0935\u094d\u092f\u093e\u092a\u0915 \u0935\u093f\u0924\u0930\u0923<\/li>\n\n\n\n<li>\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 \u0932\u094b\u0917\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u0915\u093e\u0930\u094d\u092f\u093e\u0924\u094d\u092e\u0915 \u0938\u0941\u0927\u093e\u0930<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0915\u0902\u092a\u0928\u0940 \u0928\u0947 \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0935\u093f\u0915\u093e\u0938 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0915\u0947 \u0926\u094c\u0930\u093e\u0928 \u0930\u094b\u0917\u093f\u092f\u094b\u0902, \u092a\u0930\u093f\u0935\u093e\u0930\u094b\u0902, \u0936\u094b\u0927\u0915\u0930\u094d\u0924\u093e\u0913\u0902, \u0935\u0915\u093e\u0932\u0924 \u0938\u0902\u0917\u0920\u0928\u094b\u0902 \u0914\u0930 \u0935\u094d\u092f\u093e\u092a\u0915 \u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u0938\u092e\u0941\u0926\u093e\u092f \u0926\u094d\u0935\u093e\u0930\u093e \u0928\u093f\u092d\u093e\u0908 \u0917\u0908 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u092d\u0942\u092e\u093f\u0915\u093e \u0915\u094b \u092d\u0940 \u0938\u094d\u0935\u0940\u0915\u093e\u0930 \u0915\u093f\u092f\u093e\u0964.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 id=\"dynes-broader-duchenne-pipeline\" class=\"wp-block-heading\">\u0921\u093e\u0907\u0928 \u0915\u0940 \u0935\u094d\u092f\u093e\u092a\u0915 \u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092a\u093e\u0907\u092a\u0932\u093e\u0907\u0928<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u091c\u0947\u0921-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\u0928, Dyne Therapeutics \u0915\u0947 \u0935\u094d\u092f\u093e\u092a\u0915 \u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 \u0935\u093f\u0915\u093e\u0938 \u0915\u093e\u0930\u094d\u092f\u0915\u094d\u0930\u092e \u0915\u093e \u0915\u0947\u0935\u0932 \u090f\u0915 \u0939\u093f\u0938\u094d\u0938\u093e \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0915\u0902\u092a\u0928\u0940 \u0905\u0928\u094d\u092f \u0906\u0928\u0941\u0935\u0902\u0936\u093f\u0915 \u0909\u0924\u094d\u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928\u094b\u0902 \u0915\u094b \u0932\u0915\u094d\u0937\u093f\u0924 \u0915\u0930\u0928\u0947 \u0935\u093e\u0932\u0940 \u0915\u0908 \u0905\u0924\u093f\u0930\u093f\u0915\u094d\u0924 \u092a\u094d\u0930\u093e\u092f\u094b\u0917\u093f\u0915 \u090f\u0915\u094d\u0938\u0949\u0928 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0925\u0947\u0930\u0947\u092a\u0940 \u0915\u094b \u092d\u0940 \u0906\u0917\u0947 \u092c\u0922\u093c\u093e \u0930\u0939\u0940 \u0939\u0948\u0964.<\/p>\n\n\n\n<h3 id=\"dyne-253\" class=\"wp-block-heading\">1\u091f\u0940\u092a\u0940166\u091f\u0940-253<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u092f\u0939 \u0909\u0928 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u0921\u093f\u091c\u093c\u093e\u0907\u0928 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948 \u091c\u094b \u090f\u0915\u094d\u0938\u0949\u0928 53 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u092f\u0941\u0915\u094d\u0924 \u0939\u0948\u0902\u0964.<\/p>\n\n\n\n<h3 id=\"dyne-245\" class=\"wp-block-heading\">1\u091f\u0940\u092a\u0940166\u091f\u0940-245<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u092f\u0939 \u0909\u0928 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u0921\u093f\u091c\u093c\u093e\u0907\u0928 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948 \u091c\u094b \u090f\u0915\u094d\u0938\u0949\u0928 45 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u092f\u0941\u0915\u094d\u0924 \u0939\u0948\u0902\u0964.<\/p>\n\n\n\n<h3 id=\"dyne-244\" class=\"wp-block-heading\">1\u091f\u0940\u092a\u0940166\u091f\u0940-244<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u092f\u0939 \u0909\u0928 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u0921\u093f\u091c\u093c\u093e\u0907\u0928 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948 \u091c\u094b \u090f\u0915\u094d\u0938\u0949\u0928 44 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u092f\u0941\u0915\u094d\u0924 \u0939\u0948\u0902\u0964.<\/p>\n\n\n\n<h3 id=\"dyne-255\" class=\"wp-block-heading\">1\u091f\u0940\u092a\u0940166\u091f\u0940-255<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u092f\u0939 \u0909\u0928 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u0921\u093f\u091c\u093c\u093e\u0907\u0928 \u0915\u093f\u092f\u093e \u0917\u092f\u093e \u0939\u0948 \u091c\u094b \u090f\u0915\u094d\u0938\u0949\u0928 55 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u092f\u0941\u0915\u094d\u0924 \u0939\u0948\u0902\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u092f\u0926\u093f \u092f\u0947 \u0915\u093e\u0930\u094d\u092f\u0915\u094d\u0930\u092e \u0938\u092b\u0932 \u0939\u094b\u0924\u0947 \u0939\u0948\u0902, \u0924\u094b \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 \u0935\u094d\u092f\u0915\u094d\u0924\u093f\u092f\u094b\u0902 \u0915\u0947 \u090f\u0915 \u092c\u0939\u0941\u0924 \u092c\u0921\u093c\u0947 \u0905\u0928\u0941\u092a\u093e\u0924 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u091a\u093e\u0930 \u0915\u0947 \u0935\u093f\u0915\u0932\u094d\u092a\u094b\u0902 \u0915\u093e \u0935\u093f\u0938\u094d\u0924\u093e\u0930 \u0939\u094b \u0938\u0915\u0924\u093e \u0939\u0948\u0964.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 id=\"what-this-means-for-the-duchenne-community\" class=\"wp-block-heading\">\u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u0938\u092e\u0941\u0926\u093e\u092f \u0915\u0947 \u0932\u093f\u090f \u0907\u0938\u0915\u093e \u0915\u094d\u092f\u093e \u0905\u0930\u094d\u0925 \u0939\u0948?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u0926\u094d\u0935\u093e\u0930\u093e BLA \u0915\u0940 \u0938\u094d\u0935\u0940\u0915\u0943\u0924\u093f \u090f\u0915 \u0905\u0902\u0924\u093f\u092e \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u0947 \u092c\u091c\u093e\u092f \u090f\u0915 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0928\u093f\u092f\u093e\u092e\u0915 \u092e\u0940\u0932 \u0915\u093e \u092a\u0924\u094d\u0925\u0930 \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0939\u093e\u0932\u093e\u0902\u0915\u093f, \u0907\u0938\u0938\u0947 \u092f\u0939 \u092a\u0924\u093e \u091a\u0932\u0924\u093e \u0939\u0948 \u0915\u093f:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>FDA \u0928\u0947 z-rostudirsen \u0915\u0940 \u0914\u092a\u091a\u093e\u0930\u093f\u0915 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0936\u0941\u0930\u0942 \u0915\u0930 \u0926\u0940 \u0939\u0948\u0964.<\/strong><\/li>\n\n\n\n<li>\u092a\u094d\u0930\u093e\u0925\u092e\u093f\u0915\u0924\u093e \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u093e \u0915\u0940 \u0938\u0902\u092d\u093e\u0935\u093f\u0924 \u092e\u0939\u0924\u094d\u0924\u093e \u0915\u094b \u0926\u0930\u094d\u0936\u093e\u0924\u0940 \u0939\u0948\u0964.<\/li>\n\n\n\n<li>\u092f\u0939 \u0905\u0928\u0941\u092a\u094d\u0930\u092f\u094b\u0917 \u0938\u093e\u0902\u0916\u094d\u092f\u093f\u0915\u0940\u092f \u0930\u0942\u092a \u0938\u0947 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u094b\u092b\u093f\u0928 \u0909\u0924\u094d\u092a\u093e\u0926\u0928 \u0921\u0947\u091f\u093e \u0914\u0930 \u0909\u0924\u094d\u0938\u093e\u0939\u091c\u0928\u0915 \u0915\u093e\u0930\u094d\u092f\u093e\u0924\u094d\u092e\u0915 \u092a\u0930\u093f\u0923\u093e\u092e\u094b\u0902 \u0926\u094d\u0935\u093e\u0930\u093e \u0938\u092e\u0930\u094d\u0925\u093f\u0924 \u0939\u0948\u0964.<\/li>\n\n\n\n<li><strong>\u0907\u0938 \u0938\u0902\u092c\u0902\u0927 \u092e\u0947\u0902 \u0928\u093f\u092f\u093e\u092e\u0915 \u0928\u093f\u0930\u094d\u0923\u092f 21 \u091c\u0928\u0935\u0930\u0940, 2027 \u0915\u094b \u0906\u0928\u0947 \u0915\u0940 \u0909\u092e\u094d\u092e\u0940\u0926 \u0939\u0948\u0964.<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u092f\u0926\u093f \u092e\u0902\u091c\u0942\u0930\u0940 \u092e\u093f\u0932 \u091c\u093e\u0924\u0940 \u0939\u0948, \u0924\u094b \u091c\u093c\u0947\u0921-\u0930\u094b\u0938\u094d\u091f\u0941\u0921\u093f\u0930\u0938\u0947\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 \u0935\u094d\u092f\u0915\u094d\u0924\u093f\u092f\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u090f\u0915 \u0914\u0930 \u0909\u092a\u091a\u093e\u0930 \u0935\u093f\u0915\u0932\u094d\u092a \u092c\u0928 \u0938\u0915\u0924\u093e \u0939\u0948 \u091c\u094b \u090f\u0915\u094d\u0938\u0949\u0928 51 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u092f\u0941\u0915\u094d\u0924 \u0939\u0948\u0902, \u091c\u093f\u0938\u0938\u0947 \u0907\u0938 \u0935\u093f\u0928\u093e\u0936\u0915\u093e\u0930\u0940 \u0906\u0928\u0941\u0935\u0902\u0936\u093f\u0915 \u092c\u0940\u092e\u093e\u0930\u0940 \u0915\u0947 \u0932\u093f\u090f \u091a\u093f\u0915\u093f\u0924\u094d\u0938\u0940\u092f \u092a\u0930\u093f\u0926\u0943\u0936\u094d\u092f \u0915\u093e \u0914\u0930 \u0935\u093f\u0938\u094d\u0924\u093e\u0930 \u0939\u094b\u0917\u093e\u0964.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0907\u0938 \u092a\u0947\u091c \u0915\u094b \u092b\u093c\u0949\u0932\u094b \u0915\u0930\u0947\u0902<\/strong>&nbsp;&gt;&gt;&gt;&nbsp;<a href=\"https:\/\/dmdwarrior.com\/hi\/clinical-trials\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u0915\u0947 \u0932\u093f\u090f \u0938\u092d\u0940 \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u092a\u0930\u0940\u0915\u094d\u0937\u0923<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Families affected by Duchenne muscular dystrophy (DMD) received encouraging news as Dyne Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for z-rostudirsen (formerly DYNE-251). The investigational therapy is being developed for people with Duchenne muscular dystrophy amenable to exon 51 skipping. The FDA has also granted [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":8260,"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-8259","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":"FDA \u0928\u0947 z-rostudirsen \u0915\u0947 \u0932\u093f\u090f Dyne Therapeutics \u0915\u0947 \u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 \u0915\u094b \u0938\u094d\u0935\u0940\u0915\u093e\u0930 \u0915\u0930 \u0932\u093f\u092f\u093e \u0939\u0948, \u091c\u093f\u0938\u0938\u0947 \u090f\u0915\u094d\u0938\u0949\u0928 51 \u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0915\u0947 \u0932\u093f\u090f \u0909\u092a\u092f\u0941\u0915\u094d\u0924 \u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 \u0915\u0947 \u0909\u092a\u091a\u093e\u0930 \u0939\u0947\u0924\u0941 \u092a\u094d\u0930\u093e\u0925\u092e\u093f\u0915\u0924\u093e \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u0926\u093e\u0928 \u0915\u0940 \u0917\u0908 \u0939\u0948\u0964 \u091c\u093e\u0928\u093f\u090f \u0907\u0938 \u0909\u092a\u0932\u092c\u094d\u0927\u093f \u0915\u093e \u0915\u094d\u092f\u093e \u0905\u0930\u094d\u0925 \u0939\u0948, \u091c\u0928\u0935\u0930\u0940 2027 \u0915\u0940 PDUFA \u0924\u093f\u0925\u093f \u0915\u094d\u092f\u093e \u0939\u0948, \u0914\u0930 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0914\u0930 \u092a\u0930\u093f\u0935\u093e\u0930\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u0906\u0917\u0947 \u0915\u094d\u092f\u093e \u0939\u094b\u0917\u093e\u0964.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/8259","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=8259"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/8259\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media\/8260"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media?parent=8259"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/categories?post=8259"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/tags?post=8259"}],"curies":[{"name":"\u0921\u092c\u094d\u0932\u094d\u092f\u0942\u092a\u0940","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}