FDA confirms issue of refusal to file letter for roluperidone NDA for negative symptoms in patients with schizophrenia
Minerva Neurosciences, Inc. announced that, following the Type A meeting held on November 30, 2022, the FDA has confirmed that the refuse to file letter dated October 14, 2022 remains in effect in respect of the Company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia
“We are very disappointed to announce that the FDA has confirmed that it will not file our NDA for roluperidone for the treatment of negative symptoms of schizophrenia,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “We will continue to work with the FDA regarding their feedback and assess the next steps for roluperidone.”
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