Xadago (safinamide) for Parkinson’s disease (PD) is back on track in the US as the FDA has informed the company and its partners, Zambon and US WorldMeds, that no further clinical studies will be required following the 29 March complete response letter. Newron will re-submit Xadago’s NDA by end November and now anticipates US approval mid-2017. In Europe the Xadago roll-out is ongoing, with commercial partner Zambon having launched the product in multiple European countries. We value Newron at CHF494m or CHF34.7/share.

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