Micro-X Secures A$2.5M DHS Contract Extension Amidst Scholar Rock’s FDA Setback

By / / Breaking News

Key Takeaways

  • Micro-X Ltd (MX1) has been awarded a A$2.5 million contract extension by the US Department of Homeland Security (DHS), bringing the total value of its DHS contract to A$11.8 million over three years.
  • Scholar Rock Holding Corp. (SRRK) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA), indicating that its muscle weakness drug, apitegromab, will not be approved for Type 2 and Type 3 spinal muscular atrophy (SMA).
  • Scholar Rock's shares experienced a substantial decline, falling as much as 48% in pre-market trading, following the FDA's decision.
  • The FDA cited that data from the Phase 2 TOPAZ study did not provide sufficient evidence to support the effectiveness of apitegromab for non-ambulatory patients with Type 2 and Type 3 SMA.

Micro-X Ltd (MX1), an Australian company specializing in cold cathode X-ray technology, announced a significant A$2.5 million contract extension from the US Department of Homeland Security (DHS). This extension is dedicated to the ongoing development of its miniaturised X-ray technology, 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 A$11.8 million over a three-year period, reflecting continued confidence in Micro-X's innovative medical device solutions.

In contrast, Scholar Rock Holding Corp. (SRRK) faced a major setback as the US FDA issued a Complete Response Letter (CRL) for its investigational drug, apitegromab. The drug was being developed for the treatment of Type 2 and Type 3 spinal muscular atrophy (SMA), a rare genetic neuromuscular disorder.

The FDA's decision indicated that the current data from the Phase 2 TOPAZ study did not provide sufficient evidence to support the effectiveness of apitegromab for non-ambulatory patients with Type 2 and Type 3 SMA. This rejection led to a sharp decline in Scholar Rock's stock, with shares falling by approximately 48% 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's development.

Disclaimer: This article is for informational purposes only and does not constitute financial advice. We are not financial professionals. The authors and/or site operators may hold positions in the companies or assets mentioned. Always do your own research before making financial decisions.
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