Minerva Neurosciences Gets FDA Confirmation for NDA for Roluperidone

By Chris Wack

Minerva Neurosciences said Wednesday that it received confirmation from the Food and Drug Administration that its New Drug Application for roluperidone for the treatment of schizophrenia has been filed in accordance with its recent Appeal Granted letter.

The company said the FDA also assigned a standard review classification.

The FDA has assigned a Prescription Drug User Fee Act goal date of Feb. 26, 2024.

The FDA advised that it identified potential review issues that had been previously cited in its refuse-to-file decision letter, which included those discussed at the Type C meeting in March 2022.

Minerva shares were up 18% to $8.01 in premarket trading.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

05-10-23 0842ET