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Stock Market & Financial Investment News

News Breaks
February 25, 2013
18:02 EDTMNOVFDA grants fast track designation for MedicNova's MN-166
MediciNova and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), announced that it has received Fast Track designation from the U.S. FDA for MN-166 (ibudilast) for the treatment of methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need. An important feature of the FDA's Fast Track program is that it emphasizes early and frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.
News For MNOV From The Last 14 Days
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February 16, 2015
18:14 EDTMNOVMediciNova says MN-166 trial enrolled 30 of 60 subjects
MediciNova announced that the ongoing clinical trial of MN-166 in amyotrophic lateral sclerosis has enrolled 30 of the 60 subjects planned for participation. The trial is a randomized, double-blind, placebo-controlled study which includes a six-month treatment period followed by a six-month open-label extension. The study is evaluating several efficacy endpoints including functional activity, respiratory function, muscle strength, and non-invasive ventilation utilization in addition to monitoring the safety and tolerability of MN-166 60 mg/day versus placebo when administered in combination with riluzole in subjects with ALS.

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