Newron stock jumps on hopes for Xadago drug

July 26, 2016 8:05 AM

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* The Swiss-listed Italian group and partners Zambon and US WorldMeds announced the U.S. Food and Drug Administration (FDA) and its Controlled Substance Staff (CSS) no longer require Newron to perform any studies to clinically evaluate the potential abuse liability or dependence/withdrawal effects of Xadago.

* A complete response letter from the FDA in March did not require submission of any additional new data/studies/analyses for efficacy or safety in patients with Parkinson's disease, thus Newron will now expedite re-submission of the New Drug Application (NDA) to the FDA.

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