Minerva Neurosciences Shares Rise 25% FDA Files NDA for Roluperidone
By Chris Wack
Minerva Neurosciences, Inc. shares were up 25%, to $3.50, after the company said that the U.S. Food and Drug Administration filed its New Drug Application for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
The company said the decision to file the NDA follows its request for formal dispute resolution and appeal of FDA's October 2022 refuse to file letter.
The issues cited in the refuse-to-file decision included those discussed at the type C meeting in April 2022. In granting the appeal, the FDA deciding official agreed with the company that the issues cited in the refuse-to-file decision should be considered during FDA's review of the NDA.
Minerva Neurosciences shares are down 15% in the past 12 months.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
May 01, 2023 10:15 ET (14:15 GMT)
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