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  • The FDA has lifted the clinical hold placed on Viking Therapeutics Inc’s VKTX trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD). 
  • As a result, the company expects to resume study enrollment in the coming weeks.
  • The FDA lifted the clinical hold following its review of results from an in vivo genotoxicity study that it had requested due to the study being conducted with multiple doses in patients. 
  • Related: Viking Therapeutics’ Early Stage Trial On FDA Hold In Rare Metabolic Disorder.
  • Viking had planned to conduct this study before Phase 2 but accelerated its execution based on FDA’s request.
  • The results showed no evidence of genotoxicity following exposure to VK0214. The company does not believe that the temporary clinical hold has significantly impacted the long-term development timeline for VK0214.
  • The Phase 1b study of VK0214 is designed to enroll patients with adrenomyeloneuropathy (AMN), the most common form of X-ALD. 
  • Price Action: VKTX shares traded 2.30% higher at $3.56 on the last check Tuesday.

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