Newron Pharmaceuticals - Moving full steam towards pivotal studies
Newron Pharmaceuticals’ H124 results reflect a period of positive traction for lead clinical asset evenamide, with stellar clinical data as an add-on treatment in schizophrenia, building a strong foundation for the upcoming, potentially pivotal Phase III programme (study 017). While the Phase III trial will initially focus on treatment-resistant schizophrenia (TRS), we note the likelihood of the trial expanding to cover patients with poorly managed symptoms, as evaluated in the prior Phase II/III 008A study, which we have reflected in our estimates. With discussions focused on securing the most beneficial partnering option, management expects the trial to initiate in H125, with funding in place to achieve this milestone. Our valuation adjusts to CHF245.8m or CHF12.8/share (previously CHF219.1m or CHF12.3/share).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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