No Panic At Newron Over Delayed Schizophrenia Drug Trial

Although the US FDA raised concerns about a rat toxicity trial, causing shares to slide, Italy's Newron believes the trial delay for schizophrenia therapy evenamide is just a blip.

Clock_Stone
The clock has stopped on a pivotal trial for evenamide • Source: Shutterstock

While the markets reacted badly to the news Newron Pharmaceuticals SPA is to delay starting the pivotal program for its closely watched schizophrenia therapy evenamide, the Italian-headquartered drugmaker is confident that concerns raised by the US Food and Drug Administration over central nervous system events seen in animals can be allayed quickly.

Newron received a communication from the FDA indicating concern on findings from a recently completed toxicity study in rats as well as CNS events at higher doses in dogs, and the potential implication of these findings for patients

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