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FDA Denies Approval of Roluperidone for Negative Symptoms of Schizophrenia

Roluperidone is an investigational drug intended to specifically block the serotonin receptor subtype, 5-HT2A, as well as the sigma2 and adrenergic-α1A receptors.

Remy luthringerMinerva neurosciencesDrug administrationComplete response letterNew drug applicationNegative syndrome scaleNegative symptoms factor scoreExecutive chairman

Minerva stock falls as FDA rejects schizophrenia drug

Minerva stock falls as FDA rejects schizophrenia drug
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Minerva Neurosciences (NERV) Receives CRL from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

Minerva Neurosciences (NERV) Receives CRL from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
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Remy luthringerCompany new drug applicationMinerva neurosciences incDrug administrationMinerva neurosciencesComplete response letterNew drug applicationExecutive chairmanChief executive officer

FDA Issues CRL for Roluperidone for Treatment of Negative Symptoms in Schizophrenia

Minerva Neurosciences announced the receipt of a Complete Response Letter for roluperidone in treatment of negative symptoms in patients with schizophrenia on February 27, 2024 despite clinical trial data indicating improved Negative Symptom Factor Scores and Personal and Social Performance scale scores.

Remy luthringerMinerva neurosciencesMichael davidsonNicosia university medical schoolMinerva neurosciences incDrug administrationComplete response letterNegative symptom factor scoresSocial performanceNeurosciences receives complete response letterNew drug applicationNegative symptomsUs food and drug administrationFood and drug administration

Minerva Neurosciences, Inc: Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

Minerva Neurosciences, Inc: Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
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Frederick ahlholmMinerva neurosciencesHelen shikRemy luthringerCompany new drug applicationExchange commission onMinerva neurosciences incExchange commissionShik communicationsDrug administrationComplete response letterNew drug applicationExecutive chairmanChief executive officerPrivate securities litigation reform actAnnual report