{"id":53531,"date":"2025-09-23T19:38:26","date_gmt":"2025-09-23T23:38:26","guid":{"rendered":"https:\/\/stockmarketwatch.com\/stock-market-news\/micro-x-secures-a2-5m-dhs-contract-extension-amidst-scholar-rocks-fda-setback\/53531\/"},"modified":"2025-09-23T19:38:26","modified_gmt":"2025-09-23T23:38:26","slug":"micro-x-secures-a2-5m-dhs-contract-extension-amidst-scholar-rocks-fda-setback","status":"publish","type":"post","link":"https:\/\/www2.stockmarketwatch.com\/stock-market-news\/micro-x-secures-a2-5m-dhs-contract-extension-amidst-scholar-rocks-fda-setback\/53531\/","title":{"rendered":"Micro-X Secures A$2.5M DHS Contract Extension Amidst Scholar Rock&#8217;s FDA Setback"},"content":{"rendered":"<h2>Key Takeaways<\/h2>\n<ul>\n<li><strong>Micro-X Ltd (<a href=\"\/stock\/MX1\">MX1<\/a>)<\/strong> has been awarded a <strong>A$2.5 million<\/strong> contract extension by the <strong>US Department of Homeland Security (DHS)<\/strong>, bringing the total value of its DHS contract to <strong>A$11.8 million<\/strong> over three years.<\/li>\n<li><strong>Scholar Rock Holding Corp. (<a href=\"\/stock\/SRRK\">SRRK<\/a>)<\/strong> received a <strong>Complete Response Letter (CRL)<\/strong> from the <strong>U.S. Food and Drug Administration (FDA)<\/strong>, indicating that its muscle weakness drug, <strong>apitegromab<\/strong>, will not be approved for Type 2 and Type 3 spinal muscular atrophy (SMA).<\/li>\n<li>Scholar Rock&#39;s shares experienced a substantial decline, <em>falling as much as 48%<\/em> in <a href=\"https:\/\/stockmarketwatch.com\/movers\/premarket\" data-internallinksmanager029f6b8e52c=\"7\" title=\"Premarket Movers\">pre-market trading<\/a>, following the FDA&#39;s decision.<\/li>\n<li>The FDA cited that data from the Phase 2 TOPAZ study <em>did not provide sufficient evidence to support the effectiveness of apitegromab<\/em> for non-ambulatory patients with Type 2 and Type 3 SMA.<\/li>\n<\/ul>\n<p>Micro-X Ltd (<a href=\"\/stock\/MX1\">MX1<\/a>), an Australian company specializing in cold cathode X-ray technology, announced a significant <strong>A$2.5 million<\/strong> contract extension from the <strong>US Department of Homeland Security (DHS)<\/strong>. This extension is dedicated to the ongoing development of its <em>miniaturised X-ray technology<\/em>, specifically for a mobile, point-of-care computed tomography (CT) brain scanner designed for stroke diagnosis. The latest award increases the total value of the DHS contract to <strong>A$11.8 million<\/strong> over a three-year period, reflecting continued confidence in Micro-X&#39;s innovative medical device solutions.<\/p>\n<p>In contrast, Scholar Rock Holding Corp. (<a href=\"\/stock\/SRRK\">SRRK<\/a>) faced a major setback as the <strong>US FDA<\/strong> issued a <strong>Complete Response Letter (CRL)<\/strong> for its investigational drug, <strong>apitegromab<\/strong>. The drug was being developed for the treatment of <em>Type 2 and Type 3 spinal muscular atrophy (SMA)<\/em>, a rare genetic neuromuscular disorder.<\/p>\n<p>The FDA&#39;s decision indicated that the current data from the Phase 2 TOPAZ study <em>did not provide sufficient evidence to support the effectiveness of apitegromab<\/em> for non-ambulatory patients with Type 2 and Type 3 SMA. This rejection led to a sharp decline in Scholar Rock&#39;s stock, with shares <em>falling by approximately 48%<\/em> in pre-market trading following the announcement. Scholar Rock stated its intention to engage with the FDA to discuss the CRL and determine the appropriate next steps for the drug&#39;s development.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Key Takeaways Micro-X Ltd (MX1) has been awarded a A$2.5 million contract extension by the US Department of Homeland Security [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":50383,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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