Newron Pharmaceuticals Advances Phase III Program for Schizophrenia Treatment

Newron Pharmaceuticals SpA ( (CH:NWRN) ) just unveiled an announcement.

Newron Pharmaceuticals has received approval for its pivotal Phase III development program ENIGMA-TRS, which will evaluate Evenamide as an add-on therapy for treatment-resistant schizophrenia (TRS). This program, consisting of two studies, aims to meet regulatory requirements for marketing authorization in major markets like the USA and Europe. The approval marks a significant step for Newron, potentially enhancing its market position by addressing the unmet medical need for effective TRS treatments. The studies will assess the efficacy, tolerability, and safety of Evenamide, with patient recruitment starting immediately and results expected in late 2026.

More about Newron Pharmaceuticals SpA

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company specializing in the development of innovative therapies for central and peripheral nervous system disorders. Based in Bresso, near Milan, Italy, the company’s lead drug candidate is Evenamide, a first-in-class glutamate modulator aimed at treating treatment-resistant schizophrenia (TRS) and inadequately responding schizophrenia patients. Newron has a successful history in CNS therapies, including the Parkinson’s drug Xadago® (Safinamide), and has established licensing agreements with EA Pharma and Myung In Pharm for the development and commercialization of Evenamide in Asia.

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