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Minerva Posts Positive Bioequivalence Results For Schizophrenia Candidate Formulations
Thursday, September 30, 2021 - 10:32am | 243Minerva Neurosciences Inc (NASDAQ: NERV) announced results from a bioequivalence study comparing roluperidone formulations used in Phase 2b and Phase 3 trials and the planned commercial formulation. Related Link: Minerva's Schizophrenia Candidate Shows Long Term...
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FDA Approves First And Only Twice-Yearly Schizophrenia Drug
Wednesday, September 1, 2021 - 12:30pm | 227The FDA has approved a long-acting schizophrenia drug from Janssen, a unit of Johnson & Johnson (NYSE: JNJ) Previously known as paliperidone palmitate, Invega Hafyera is a twice-yearly injectable. It's the first and only twice-yearly med for the condition. ...
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Teva-MedinCell's Schizophrenia Treatment Candidate Under FDA Review
Wednesday, September 1, 2021 - 7:27am | 271The FDA has accepted Teva Pharmaceutical Industries Ltd (NYSE: TEVA) and MedinCell's marketing application seeking approval for TV-46000/mdc-IRM in schizophrenia. TV-46000/mdc-IRM is a risperidone extended-release injectable suspension for subcutaneous use. The...
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Cerevel Therapeutics Stock Shoots Higher As Schizophrenia Treatment Tops Placebo On Antipsychotic Activity
Tuesday, June 29, 2021 - 7:10am | 274Cerevel Therapeutics Holdings Inc (NASDAQ: CERE) has announced results from its Phase 1b trial of CVL-231 in adult patients with schizophrenia. CVL-231 was generally well-tolerated, and discontinuation rates were similar between CVL-231 and placebo in the six weeks of dosing,...
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Alkermes Shares Move Higher On FDA Approval Of Schizophrenia, Bipolar Med
Tuesday, June 1, 2021 - 9:35am | 153The FDA has approved Alkermes plc's (NASDAQ: ALKS) Lybalvi, a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity, for schizophrenia and bipolar I disorder. The approval comes as a maintenance...
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BioXcel's Formulated Dexmedetomidine US Application For Agitation Under FDA Review
Wednesday, May 19, 2021 - 8:11am | 206The FDA has accepted for review, BioXcel Therapeutics Inc's (NASDAQ: BTAI) marketing application for BXCL501, an orally dissolving thin film formulation of dexmedetomidine. The application covers the acute treatment of agitation associated with schizophrenia and bipolar...
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Minerva Shares Surge As Schizophrenia Candidate Shows Long Term Improvement In Negative Symptoms, Functioning
Wednesday, May 12, 2021 - 6:59am | 283Minerva Neurosciences Inc (NASDAQ: NERV) has announced results from the 40-week open-label extension (OLE) of its Phase 3 trial evaluating roluperidone for the treatment of negative symptoms (NS) of schizophrenia. Over the 40-week OLE period, 333 patients participated. 166...
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Reviva Pharma Stock Trading Higher On Detailed Positive Schizophrenia Study Results
Monday, April 26, 2021 - 9:21am | 258Reviva Pharmaceuticals Holdings Inc (NASDAQ: RVPH) has announced the full details of its Phase 2 trial evaluating its lead drug candidate, RP5063 (brilaroxazine), for Acute Schizophrenia. Brilaroxazine demonstrated high affinity and selectivity for key serotonin receptors (5-HT1A/2A...
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Neurocrine/Takeda's Luvadaxistat Fails To Improve Schizophrenia Symptom Severity
Tuesday, March 2, 2021 - 9:53am | 282Neurocrine Biosciences Inc (NASDAQ: NBIX) announces topline data from Phase 2 INTERACT study evaluating luvadaxistat (NBI-1065844/TAK-831) for the treatment of negative symptoms and cognitive impairment associated with schizophrenia. Luvadaxistat is an oral, selective inhibitor...
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Psychedelics And Schizophrenia: What's The Link?
Sunday, February 21, 2021 - 1:01pm | 2544This article by Derek Beres was originally published on Psychedelic Spotlight, and appears here with permission. Psychedelics and schizophrenia share a history. Now, researchers are looking at how psychedelics may change the future. Can psychedelics help treat schizophrenia? LSD-25 sat on a...
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UPDATE: JMP Securities Initiates Coverage On Intra-Cellular Therapies
Tuesday, December 23, 2014 - 10:43am | 120Jason Butler of JMP Securities initiated coverage of Intra-Cellular Therapies (NASDAQ: ITCI) on Tuesday with a Market Outperform rating and $26 price target. “Intra-Cellular Therapies is focused on the development of ITI-007, a novel antipsychotic candidate currently in Phase 3 development for the...