Newron Pharmaceuticals - Evenamide down but not out
Newron's plans for its novel mechanism of action drug, Evenamide, due to enter late-stage development for schizophrenia, have been delayed. Specifically, the FDA has requested that Newron carry out additional short-term safety studies before larger, pivotal-stage clinical trials can be undertaken. This has taken us and the market by surprise, as we had expected the two Phase II/III trials to start in Q219 as per guidance. The delay is a setback and we therefore push back our launch expectations by 18 months to 2024, erring on the side of caution. We now value Newron at CHF653m vs CHF714m previously.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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