Newron Pharmaceuticals S.p.A.

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company dedicated to the discovery and development of novel therapies for patients suffering from diseases of the central and peripheral nervous system. Headquartered in Bresso, near Milan, Italy, the company's mission is to deliver innovative treatments that enhance the quality of life for individuals with CNS disorders.

The company's product portfolio includes Xadago® (safinamide), a treatment for Parkinson's disease that has received marketing authorization in over 20 markets globally and is commercialized through strategic partnerships. Newron's lead development asset is evenamide, a first-in-class glutamate modulator currently in Phase III clinical development for the treatment of schizophrenia, including treatment-resistant schizophrenia.

In recent news, the US Food and Drug Administration (FDA) placed a hold on the enrollment of new patients in US sites for Newron's Phase III ENIGMA-TRS 2 study of evenamide. This action followed the notification of a sudden death of a study participant at a clinical site outside the United States, though the event was assessed by the investigator as unrelated to the study treatment. Newron is actively collaborating with the FDA to provide the necessary information to resolve the hold and resume enrollment in the US, while the global ENIGMA-TRS 1 study continues as planned. Stefan Weber serves as the Chief Executive Officer of Newron Pharmaceuticals.