Nano cap Valeritas Holdings (NASDAQ:VLRX) is up 10% premarket on modest volume in reaction to the results of an investigator-initiated study comparing the delivery of U-100 regular human insulin with the V-Go device with rapid acting insulin with V-Go in type 2 diabetics.
Based on an interim analysis, the independent Data Safety and Monitoring Committee unanimously recommended stopping the study since the data showed that the delivery of regular insulin was non-inferior to rapid-acting insulin when delivered with V-Go as measured by the change in HbA1c over the treatment period.
No new safety signals were observed.
V-Go is currently approved for use with rapid-acting insulin only. The company filed a supplemental marketing application in late June seeking clearance to use V-Go with regular insulin.
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