Newron's Xadago heading for resubmission

Newron Pharmaceuticals S.p.A. (SIX:NWRN) said FDA will not require the company to conduct clinical studies of Parkinson's disease candidate Xadago safinamide to study its dependence and withdrawal effects or abuse liability. Newron said it had submitted relevant data to the agency after the company received a complete response letter for Xadago in March (see BioCentury Extra, March 29).

Newron said it expects to resubmit its NDA for Xadago by November. The CRL did not require additional data related to safety or efficacy of the candidate, which was under review as an add-on therapy for early and mid to late stage PD. ...