pharmaphorum February 28, 2024
Shares in Minerva Neurosciences have lost more than half their value after the FDA rejected its marketing application for roluperidone as a treatment for the negative symptoms of schizophrenia.
In a complete response letter (CRL), the US regulator pointed to various deficiencies in the clinical data filed in support of roluperidone and said Minerva would have to run a new clinical trial before it could accept another marketing application.
Roluperidone (MIN-101), which blocks serotonin, sigma, and α-adrenergic receptors, is designed to avoid the blockade of dopamine receptors that are associated with side effects seen with older antipsychotic drugs.
It failed a phase 3 trial in 2020, but subsequently showed evidence that it may be able to target the negative symptoms...
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