FDA hits the red light on pivotal trials at Newron, demanding new studies after raising safety concerns
Two years after Newron $NWRN came up with a mixed set of Phase IIa data for its antipsychotic evenamide, the FDA is halting their move into pivotal work while the biotech explores the implications of some new safety concerns regarding the drug.
Those concerns involve signals spotted in a newly completed rat study — which were not explained — as well as “CNS events at higher doses in dogs, and the potential implication of these findings for patients.” Regulators now want to see some new animal and human studies done to address the safety issue before they launch Phase II/III.
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