Update: Safinamide ends 2014 on a high note
Safinamide/Xadago has received a positive opinion from the European CHMP regarding its approval for mid-late stage Parkinson’s disease (PD). The formal EMA (European Medicines Agency) decision is usually made within two months (67 days) and generally concurs with the CHMP recommendation. This should trigger a milestone payment from partner Zambon and initial EU launch is anticipated in H115. Increasing Xadago’s European probability to 100% in addition to a lower discount rate reflecting the recommendation increases our Newron valuation to €321m/CHF401m or CHF30.7/share. Newron has also now re-filed safinamide in the US.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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