Waiting Game For Minerva After Roluperidone US Filing

Decision On Filing Acceptance Due In 60 Days

 
• By Alexandra Shimmings

The firm’s potential new therapy for the negative symptoms of schizophrenia is now in the hands of the US Food and Drug Administration – some have concerns over whether the supporting data will be enough.    

Abstract Squares
• Source: Shutterstock

The fate of Minerva Neurosciences, Inc.’ US filing for its novel schizophrenia drug candidate roluperidone lies in the balance as the Food and Drug Administration weighs up whether to accept a submission based on mixed clinical data.

Minerva has filed a new drug application with the US agency for a 64mg dose of roluperidone for the treatment...

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