Update: Safinamide US re-filing in coming months
The European approval decision for Newron’s lead product safinamide in Parkinson’s disease (PD) is still anticipated by YE14, which could allow for first launches in early 2015. Newron is working towards re-filing safinamide in the US during Q414 following a Refusal to File (RTF) owing to administrative errors rather than clinical omissions, and we have delayed our US launch expectation c six months to H215. This has lowered our valuation slightly to €260m/CHF325m.Newron Pharmaceuticals is a clinical stage biopharmaceutical company. Co. is focused on the development of drugs for the treatment of central nervous system disorders and pain. Co.'s pipeline include, Xadago® (safinamide), for the treatment of Parkinson's disease (PD) and PD Levodopa-induced dyskinesia; Sarizotan, for the treatment of Rett syndrome (Orphan drug status); Evenamide (NW-3509), for the treatment of Schizophrenia and Clozapine-treatment-resistant schizophrenia; and Ralfinamide for patients with specific rare pain indications (neuropathic pain).
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