Newron has received a complete response letter from the FDA for its Parkinson’s disease drug Xadago (safinamide). Specifically, the FDA has requested clinical data on the potential effect of Xadago relating to abuse liability and dependence/withdrawal effects. No further efficacy or safety data for Xadago in patients with Parkinson’s disease has been requested. In next steps Newron will meet with Controlled Substance Staff (CSS) of the FDA to discuss exact requirements to address the issue. We anticipate that Newron will need to provide data relating to abuse liability and dependence in healthy subjects, and thus additional trials may be required. As such, we place our financial forecasts and valuation under review until we receive clarity on next steps and the potential impact on regulatory approval and market launch in the US
