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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 Luthringer , Minerva Neurosciences , Drug Administration , Complete Response Letter , New Drug Application , Negative Syndrome Scale , Negative Symptoms Factor Score , Executive Chairman ,

Minerva stock falls as FDA rejects schizophrenia drug

Minerva stock falls as FDA rejects schizophrenia drug
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Remy Luthringer , Drug Administration , Stock Editorial , Drug Application , Karuna Therapeutics , Bristol Myers Squibb ,

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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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.
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Remy Luthringer , Minerva Neurosciences , Michael Davidson , Nicosia University Medical School , Minerva Neurosciences Inc , Drug Administration , Complete Response Letter , Negative Symptom Factor Scores , Social Performance , Neurosciences Receives Complete Response Letter , New Drug Application , Negative Symptoms , Us Food And Drug Administration , Food 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 Ahlholm , Minerva Neurosciences , Helen Shik , Remy Luthringer , Company New Drug Application , Exchange Commission On , Minerva Neurosciences Inc , Exchange Commission , Shik Communications , Drug Administration , Complete Response Letter , New Drug Application , Executive Chairman , Chief Executive Officer , Private Securities Litigation Reform Act , Annual Report ,