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Newron Pharmaceuticals / Equity Bottom-Up

<p>Newron and its partners Zambon and US WorldMeds have announced that the FDA has approved Xadago (safinamide) for Parkinson&#8217;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.</p>

Newron and its partners Zambon and US WorldMeds have announced that the FDA has approved Xadago (safinamide) for Parkinson&#8217;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.

<p>We anticipate that the sales and pipeline progression made by Newron in 2016 will be cemented further in 2017/18. A critical catalyst remains the US Xadago (Parkinson&#8217;s disease (PD) therapy) approval which is imminent (revised PDUFA date is 21 March); this will materially impact the share price performance. We anticipate US launch in H217 by sub licensee, US WorldMeds. Data from pipeline assets sarizotan (Rett&#8217;s syndrome, RS) and evenamide (schizophrenia) in the upcoming 18 months will highlight Newron&#8217;s diverse, innovative CNS-based R&D portfolio. We value the company at CHF530m.</p>

We anticipate that the sales and pipeline progression made by Newron in 2016 will be cemented further in 2017/18. A critical catalyst remains the US Xadago (Parkinson&#8217;s disease (PD) therapy) approval which is imminent (revised PDUFA date is 21 March); this will materially impact the share price performance. We anticipate US launch in H217 by sub licensee, US WorldMeds. Data from pipeline assets sarizotan (Rett&#8217;s syndrome, RS) and evenamide (schizophrenia) in the upcoming 18 months will highlight Newron&#8217;s diverse, innovative CNS-based R&D portfolio. We value the company at CHF530m.

Italy

Newron Pharmaceuticals SpA is a research and development biopharmaceutical company. The Company focuses on and develops therapies for the Central Nervous System (CNS) in cases such as Parkinson's disease, neuropathic low back pain and other cognitive disorders.

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Newron Pharmaceuticals (NWRN SW)

Xadago receives FDA approval in PD

Newron and its partners Zambon and US WorldMeds have announced that the FDA has approved Xadago (safinamide) for Parkinson’s disease (PD) patients...

Edison Investment Research

Marching into 2017

We anticipate that the sales and pipeline progression made by Newron in 2016 will be cemented further in 2017/18. A critical catalyst remains the...

Edison Investment Research

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