Minerva Neurosciences Receives Complete Response Letter From FDA For New Drug Application For Roluperidone For Treatment Of Negative Symptoms In Patients With Schizophrenia Due To Clinical Deficiencies
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Minerva Neurosciences received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Roluperidone, intended for treating negative symptoms in schizophrenia patients. The FDA cited clinical deficiencies including insufficient evidence from a single study, lack of data on concomitant antipsychotic administration, and inadequate long-term safety data at the proposed dose.
February 27, 2024 | 1:10 pm
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Minerva Neurosciences faces a setback with the FDA's CRL for Roluperidone, highlighting clinical deficiencies and insufficient evidence for its schizophrenia treatment.
The FDA's CRL is a significant regulatory hurdle for Minerva Neurosciences, directly impacting its potential to bring Roluperidone to market for schizophrenia treatment. The cited deficiencies suggest a delay in approval and potential additional studies, which could strain resources and delay revenue from this product. This news is likely to negatively affect investor sentiment and the stock price in the short term.
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