Shares in Newron Pharmaceuticals (SIX: NWRN) dropped nearly 4.4%to 25.15 Swiss francs on the SIX Swiss Exchange after the company said the US regulator has extended the review time of its Parkinson's disease drug by three months.
The Italian drugmaker has filed a New Drug Application (NDA) for its Xadago (safinamide) with the US Food and Drug Administration. This extends the Prescription Drug User Fee Act (PDUFA) date to March 29, 2016.
The FDA has extended the review time for the Xadago to review the late submission of additional financial disclosure forms for two clinical studies.
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