Microcap Viking gets a reprieve as FDA lifts hold on PhII study for rare metabolic disorder
The path ahead for San Diego based-Viking Therapeutics could finally be free of roadblocks. The FDA has lifted the clinical hold on its X-linked adrenoleukodystrophy (X-ALD) program, the company announced Tuesday.
Regulators lifted the hold after the biotech presented a rodent genotoxicity study, which the FDA had requested, Viking said.
“Viking had planned to conduct this study prior to Phase II but accelerated its execution based on FDA’s request,” said the company in a press release. “We look forward to resuming study activities and working to complete patient enrollment as quickly as possible,” CEO Brian Lian added in a statement.
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