UK-incorporated Mallinckrodt (NYSE: MNK) got a boost in pre-market US trading after it announced that its terlipressin had hit the main goal of a late-stage study, with the stock, which has tumbled nearly 70% over the past three months, soaring as much as 20% in early trading.
Mallinckrodt announced positive top-line results from its pivotal Phase III CONFIRM clinical study evaluating the efficacy and safety of terlipressin in 300 adults with hepatorenal syndrome type 1 (HRS-1).
The study met its primary endpoint of verified HRS-1 reversal (p=0.012). Verified HRS-1 reversal includes three components: renal function improvement, avoidance of dialysis and short-term survival. The company plans to present the data at an upcoming medical meeting.
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