Breaking: Renalytix's KidneyIntelX.dkd FDA-Approved, VSE Secures Up to $565M Contract
- June 29th, 2023
- 454 views
Shares of Renalytix plc (Nasdaq: RNLX) surged over 25% in after-hours trading following the company's announcement of receiving De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its KidneyIntelX.dkd prognostic test.
This innovative test, leveraging artificial intelligence, aims to guide care management for individuals with type 2 diabetes and early-stage chronic (diabetic) kidney disease. The FDA authorization is expected to drive increased test adoption, influence clinical guidelines, expand insurance coverage, and facilitate international regulatory approvals.
Renalytix's KidneyIntelX.dkd accurately stratifies patients into low, moderate, and high-risk levels, providing comprehensive information on the risk of progressive decline in kidney function within five years. This evaluation goes beyond the current standard of care measures, enhancing patient risk assessment and management.
$RNLX is currently trading at $2.38, up $0.54 (26.54%) in the extended session.
In other news, VSE Corporation (Nasdaq: VSEC) has secured a significant indefinite-delivery/indefinite-quantity contract worth up to $565,025,276. The contract aims to enhance the depot capability for the C-5 aircraft, providing valuable supplemental support.
The Air Force Life Cycle Management Center, based in Robins Air Force Base, Warner Robins, Georgia, serves as the contracting activity for this project, ensuring effective oversight and management.
$VSEC is trading at $55.48 in after-hours, up $0.78 (1.43%).
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