{"id":859574,"date":"2025-06-11T09:19:41","date_gmt":"2025-06-11T13:19:41","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\/"},"modified":"2025-06-11T09:19:41","modified_gmt":"2025-06-11T13:19:41","slug":"avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\/","title":{"rendered":"Avidity Biosciences to Present Topline Data from Phase 1\/2 FORTITUDE\u2122 Trial of Del-brax in People Living with Facioscapulohumeral Muscular Dystrophy at 32nd Annual FSHD Society International Research Congress"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p class=\"prntac\">\n        <i>&#8212; FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran<\/i><br \/>\n        <i>\u00a0(del-brax) in facioscapulohumeral muscular dystrophy (FSHD) &#8212;<\/i>\n      <\/p>\n<p class=\"prntac\">\n        <i>&#8212; <span class=\"xn-person\">Jeffrey M. Statland<\/span>, M.D., Professor of Neurology, <span class=\"xn-org\">University of Kansas Medical Center<\/span>, and FORTITUDE trial investigator, will present topline del-brax data from dose escalation cohorts in oral presentation &#8212;<\/i>\n      <\/p>\n<p class=\"prntac\">\n        <i>&#8212; <span class=\"xn-person\">Stephen Tapscott<\/span>, M.D., Ph.D., Professor of <\/i><br \/>\n        <i>Human Biology and Clinical Research, Fred Hutchinson Cancer Center, will highlight results on the characterization of a novel DUX4-regulated circulating biomarker in oral and poster presentations &#8212;<\/i>\n      <\/p>\n<p>\n        <span class=\"legendSpanClass\"><br \/>\n          <span class=\"xn-location\">SAN DIEGO<\/span><br \/>\n        <\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">June 11, 2025<\/span><\/span> \/PRNewswire\/ &#8212; Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs\u2122) to profoundly improve people&#8217;s lives, today announced that the company will be presenting two oral and one poster presentations at the 32nd Annual FSHD Society International Research Congress, being held <span class=\"xn-chron\">June 12-13, 2025<\/span>, in <span class=\"xn-location\">Amsterdam, the Netherlands<\/span>. Earlier this week, Avidity announced FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD).<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/974628\/Avidity_Biosciences_Logo.html\" target=\"_blank\" rel=\"nofollow\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/974628\/Avidity_Biosciences_Logo.jpg\" title=\"(PRNewsfoto\/Avidity Biosciences, Inc.)\" alt=\"(PRNewsfoto\/Avidity Biosciences, Inc.)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>\n        <b><br \/>\n          <u>32<sup>nd<\/sup> Annual FSHD Society International Research Congress Presentations<br \/><\/u><br \/>\n        <\/b>\n      <\/p>\n<ul type=\"disc\">\n<li>\n          <b>Topline Data from Dose Escalation Cohorts A and B in FORTITUDE\u2122, a Phase 1\/2 Trial Evaluating <\/b><br \/>\n          <b>Del-brax (<i>delpacibart braxlosiran<\/i>) in Adults with Facioscapulohumeral Muscular Dystrophy (FSHD)<\/b><\/p>\n<ul type=\"disc\">\n<li>\n              <b>Oral presentation:<\/b><br \/>\n              <span class=\"xn-person\">Jeffrey M. Statland<\/span>, M.D., to present <span class=\"xn-chron\">June 13, 2025<\/span>, from <span class=\"xn-chron\">5:20 &#8211; 5:40 p.m.<\/span> Central European Summer Time (CEST) \/ <span class=\"xn-chron\">11:20 &#8211; 11:40 a.m. ET<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul type=\"disc\">\n<li>\n          <b>Characterization of a promising DUX4-regulated circulating biomarker for facioscapulohumeral dystrophy (FSHD) <\/b>\n        <\/li>\n<li style=\"list-style-type: none\">\n<ul type=\"disc\">\n<li>\n              <b>Oral presentation: <\/b><br \/>\n              <span class=\"xn-person\">Stephen Tapscott<\/span>, M.D., Ph.D., Professor of Human Biology and Clinical Research, Fred Hutchinson Cancer Center, to present on <span class=\"xn-chron\">June 12, 2025<\/span>, from <span class=\"xn-chron\">6:25 &#8211; 6:30 p.m. CEST<\/span> \/ <span class=\"xn-chron\">12:25 &#8211; 12:30 p.m. ET<\/span><\/p>\n<\/li>\n<li>\n              <b>Poster presentation (#7.08):<\/b><br \/>\n              <span class=\"xn-chron\">June 12, 2025<\/span>, from <span class=\"xn-chron\">7:15 &#8211; 8:00 p.m. CEST<\/span> \/ <span class=\"xn-chron\">1:15 &#8211; 2:00 p.m. ET<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>The presentations and poster are available on the <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4446753-1&amp;h=2459529122&amp;u=https%3A%2F%2Fwww.aviditybiosciences.com%2Fplatform%2Fpublications&amp;a=publications+page\" target=\"_blank\" rel=\"nofollow\">publications page<\/a> of Avidity&#8217;s website at\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4446753-1&amp;h=880305986&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4176068-1%26h%3D232021800%26u%3Dhttps%253A%252F%252Fwww.aviditybiosciences.com%252F%26a%3Dhttps%253A%252F%252Fwww.aviditybiosciences.com&amp;a=https%3A%2F%2Fwww.aviditybiosciences.com\" target=\"_blank\" rel=\"nofollow\">https:\/\/www.aviditybiosciences.com<\/a>.<\/p>\n<p>\n        <b>About Avidity<br \/><\/b>Avidity Biosciences, Inc.&#8217;s mission is to profoundly improve people&#8217;s lives by delivering a new class of RNA therapeutics &#8211; Antibody\u00a0Oligonucleotide Conjugates (AOCs\u2122). Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare neuromuscular diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is also advancing two wholly-owned precision cardiology development candidates addressing rare genetic cardiomyopathies. In addition, Avidity is broadening the reach of AOCs with its advancing and expanding pipeline including programs in cardiology and immunology through key partnerships. Avidity is headquartered in\u00a0San Diego, CA.\u00a0For more information about our AOC platform, clinical development pipeline and people, please visit\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4446753-1&amp;h=2890276062&amp;u=https%3A%2F%2Fwww.aviditybiosciences.com%2F&amp;a=www.aviditybiosciences.com\" target=\"_blank\" rel=\"nofollow\">www.aviditybiosciences.com<\/a>\u00a0and engage with us on\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4446753-1&amp;h=1132793590&amp;u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Favidity-biosciences-llc%2F&amp;a=LinkedIn\" target=\"_blank\" rel=\"nofollow\">LinkedIn<\/a>\u00a0and\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4446753-1&amp;h=2499509370&amp;u=https%3A%2F%2Fx.com%2Faviditybio&amp;a=X\" target=\"_blank\" rel=\"nofollow\">X<\/a>.<\/p>\n<p>\n        <b>Forward-Looking Statements<br \/><\/b>Avidity cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company&#8217;s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: Avidity&#8217;s plans to present topline data from the dose escalation cohorts of the Phase 1\/2 FORTITUDE\u2122 trial; the status and availability of accelerated and full approval pathways for del-brax and Avidity&#8217;s planned participation at the 32<sup>nd<\/sup> Annual FSHD Society International Research Congress and the contents of its scheduled presentations. The inclusion of forward-looking statements should not be regarded as a representation by Avidity that any of these plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Avidity&#8217;s business and beyond its control, including, without limitation, the data and results produced from the clinical study of del-brax may not support BLA submission or accelerated or full approval, and may not be satisfactory to the FDA and other regulators; later developments with the FDA and other regulators may be inconsistent with the feedback received as of the date hereof; and the risks described in Avidity&#8217;s Annual Report on Form 10-K for the fiscal year ended\u00a0December 31, 2024\u00a0and subsequent filings with the SEC. Avidity cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that arise after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.<\/p>\n<p>\n        <b>Investor Contact:<\/b><br \/>\n        <br \/>Kat Lange<br \/>(619) 837-5014<br \/><a href=\"mailto:investors@aviditybio.com\" target=\"_blank\" rel=\"nofollow\">investors@aviditybio.com<\/a><\/p>\n<p>\n        <b>Media Contact:<\/b><br \/>\n        <br \/>\n        <span class=\"xn-person\">Kristina Coppola<\/span><br \/>\n        <br \/>(619) 837-5016<br \/><span><a href=\"mailto:media@aviditybio.com\" target=\"_blank\" rel=\"nofollow\"><span>media@aviditybio.com<\/span><\/a><\/span><\/p>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=LA07811&amp;sd=2025-06-11\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/avidity-biosciences-to-present-topline-data-from-phase-12-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-research-congress-302478339.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/avidity-biosciences-to-present-topline-data-from-phase-12-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-research-congress-302478339.html<\/a><\/p>\n<p>SOURCE  Avidity Biosciences, Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=LA07811&amp;Transmission_Id=202506110900PR_NEWS_USPR_____LA07811&amp;DateId=20250611\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire &#8212; FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran \u00a0(del-brax) in facioscapulohumeral muscular dystrophy (FSHD) &#8212; &#8212; Jeffrey M. Statland, M.D., Professor of Neurology, University of Kansas Medical Center, and FORTITUDE trial investigator, will present topline del-brax data from dose escalation cohorts in oral presentation &#8212; &#8212; Stephen Tapscott, M.D., Ph.D., Professor of Human Biology and Clinical Research, Fred Hutchinson Cancer Center, will highlight results on the characterization of a novel DUX4-regulated circulating biomarker in oral and poster presentations &#8212; SAN DIEGO , June 11, 2025 \/PRNewswire\/ &#8212; Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs\u2122) to profoundly improve people&#8217;s lives, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Avidity Biosciences to Present Topline Data from Phase 1\/2 FORTITUDE\u2122 Trial of Del-brax in People Living with Facioscapulohumeral Muscular Dystrophy at 32nd Annual FSHD Society International Research Congress&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-859574","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Avidity Biosciences to Present Topline Data from Phase 1\/2 FORTITUDE\u2122 Trial of Del-brax in People Living with Facioscapulohumeral Muscular Dystrophy at 32nd Annual FSHD Society International Research Congress - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Avidity Biosciences to Present Topline Data from Phase 1\/2 FORTITUDE\u2122 Trial of Del-brax in People Living with Facioscapulohumeral Muscular Dystrophy at 32nd Annual FSHD Society International Research Congress - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire &#8212; FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran \u00a0(del-brax) in facioscapulohumeral muscular dystrophy (FSHD) &#8212; &#8212; Jeffrey M. Statland, M.D., Professor of Neurology, University of Kansas Medical Center, and FORTITUDE trial investigator, will present topline del-brax data from dose escalation cohorts in oral presentation &#8212; &#8212; Stephen Tapscott, M.D., Ph.D., Professor of Human Biology and Clinical Research, Fred Hutchinson Cancer Center, will highlight results on the characterization of a novel DUX4-regulated circulating biomarker in oral and poster presentations &#8212; SAN DIEGO , June 11, 2025 \/PRNewswire\/ &#8212; Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs\u2122) to profoundly improve people&#8217;s lives, &hellip; Continue reading &quot;Avidity Biosciences to Present Topline Data from Phase 1\/2 FORTITUDE\u2122 Trial of Del-brax in People Living with Facioscapulohumeral Muscular Dystrophy at 32nd Annual FSHD Society International Research Congress&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-11T13:19:41+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/974628\/Avidity_Biosciences_Logo.jpg\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Avidity Biosciences to Present Topline Data from Phase 1\\\/2 FORTITUDE\u2122 Trial of Del-brax in People Living with Facioscapulohumeral Muscular Dystrophy at 32nd Annual FSHD Society International Research Congress\",\"datePublished\":\"2025-06-11T13:19:41+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\\\/\"},\"wordCount\":832,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/974628\\\/Avidity_Biosciences_Logo.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/avidity-biosciences-to-present-topline-data-from-phase-1-2-fortitude-trial-of-del-brax-in-people-living-with-facioscapulohumeral-muscular-dystrophy-at-32nd-annual-fshd-society-international-r\\\/\",\"name\":\"Avidity Biosciences to Present Topline Data from Phase 1\\\/2 FORTITUDE\u2122 Trial of Del-brax in People Living with Facioscapulohumeral Muscular Dystrophy at 32nd Annual FSHD Society International Research Congress - 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