Minerva Neurosciences Says FDA Denies Request for Pre-NDA Meeting

By Chris Wack

Minerva Neurosciences Inc. said the U.S. Food and Drug Administration has denied the company's request for a pre-new drug application meeting for roluperidone and responded that a "type C" guidance meeting would be more appropriate to discuss the evidence for use of roluperidone as a monotherapy.

The biopharmaceutical company said that, subject to the timing of and feedback from the FDA at a type C guidance meeting, which it plans to request, the company hasn't changed its previously announced projected timeline for submission of the NDA in the first half of 2022.

"We thank the FDA for suggesting a Type C meeting to discuss roluperidone as a monotherapy for the treatment of negative symptoms in patients with schizophrenia," said Remy Luthringer, chief executive of Minerva.

Minerva shares were down 7% to $1.37 in premarket trading.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

11-03-21 0902ET