bullish
Xadago receives FDA approval in PD
SUMMARY
Newron and its partners Zambon and US WorldMeds have announced that the FDA has approved Xadago (safinamide) for Parkinson’s disease (PD) patients as an add-on therapy to levodopa/carbidopa. While we had expected approval (following the revised PDUFA date of 21 March), the certainty of approval removes a major overhang on the stock, and as such we expect a positive share price reaction. We expect launch in the US market in H217 by sub licensee US WorldMeds. Our valuation of Newron remains unchanged at CHF530m.
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- Xadago receives FDA approval in PD22 Mar 2017
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