Newron shares slide as FDA delays evenamide studies

Italian biopharma Newron Pharmaceuticals (SIX: NWRN) looked set to close around 13% down on Tuesday after bad news was announced surrounding evenamide, a potential add-on therapy for the treatment of patients with positive symptoms of schizophrenia.

The company received a communication from the US Food and Drug Administration (FDA) indicating concern on findings from a recently-completed study in rats as well as central nervous system events at higher doses in dogs, and the potential implication of these findings for patients.

This led the FDA to request Newron to delay initiation of the proposed Phase II/III pivotal studies with evenamide prior to completing additional short-term explanatory studies in rats and human subjects to address these concerns.