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cerevel Cerevel Therapeutics Reports Third Quarter 2021 Financial Results and Pipeline Updates November 10 , 2021 Phase 1 data for darigabat in acute anxiety now expected by the end of Q1 2022 Submissions of additional PK / PD data for CVL - 231 in schizophrenia accepted for presentation at the Annual Meeting of the American College of Neuropsychopharmacology Conference call and webcast scheduled today at 8:00 a.m. ET CAMBRIDGE , Mass . , Nov. 10 , 2021 ( GLOBE NEWSWIRE ) -- Cerevel Therapeutics ( Nasdaq : CERE ) , a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases , today reported financial results for the quarter ended September 30 , 2021 and provided key pipeline and business updates . " We continue to execute on our vision of becoming the premier neuroscience company as we advance our pipeline and secure the capital required for our next stage of growth as a company , " said Tony Coles , M.D. , chairperson and chief executive officer of Cerevel Therapeutics . " We are advancing our clinical programs with speed and determination and preparing our company for the future in order to bring medicines to patients with neuroscience diseases including schizophrenia , anxiety , epilepsy , Parkinson's , and dementia - related apathy as quickly as possible . " Pipeline Highlights Leveraging its deep understanding of neurocircuitry and receptor subtype selectivity , Cerevel continues to execute on its broad pipeline of novel neuroscience drug candidates . CVL - 231 : CVL - 231 is an M4 - selective positive allosteric modulator ( PAM ) in development as a once - daily medication for schizophrenia without the need for titration . In June 2021 , Cerevel announced positive topline data for its Phase 1b trial of CVL - 231 in people with schizophrenia . • During its virtual R & D event on October 7 , Cerevel discussed new pharmacokinetic ( PK ) and PET receptor occupancy data that will inform the design of the upcoming Phase 2 program . • Cerevel will present additional PK and pharmacodynamic ( PD ) data at the Annual Meeting of the American College of Neuropsychopharmacology ( ACNP ) in December 2021 . • The comprehensive Phase 2 program for CVL - 231 will consist of one or more adequately - powered placebo - controlled Phase 2b trials to evaluate the full dose range for CVL - 231 in schizophrenia . • At least one of the multiple dose arms will include the 30 mg once - daily dose regimen without titration . This dose regimen showed a statistically significant 12.7 point placebo - adjusted improvement on the Positive and Negative Symptom Scale ( PANSS ) Total Score in the Phase 1b trial . • The anticipated Phase 2 trial design will follow established precedent and include six weeks of in - patient treatment with a patient profile similar to Part B of the Phase 1b trial and a primary endpoint of the change from baseline on the PANSS Total Score . • Additionally , the company plans to evaluate the potential of this mechanism in other populations , including dementia - related psychosis . • Cerevel expects to disclose the full details of its Phase 2 program in schizophrenia by mid - to - late Q1 2022 . Darigabat ( formerly CVL - 865 ) : Darigabat is an α2 / 3 / 5 - selective GABAA receptor PAM currently under development for anxiety and epilepsy . • Cerevel is conducting a Phase 1 proof - of - principle trial in acute anxiety using a well - established CO2 inhalation challenge model in healthy volunteers . • Data for this trial are now expected by the end of the first quarter of 2022 . • Cerevel is also conducting the REALIZE trial , a Phase 2 proof - of - concept trial in focal epilepsy . This trial remains ongoing ; multiple patients have completed the 8 - week maintenance portion of the trial and have opted to participate in the accompanying open - label extension trial ( REALIZE OLE ) . • Data from the REALIZE trial are expected in the second half of 2022 . Tavapadon : Tavapadon is a D1 / D5 partial agonist currently in Phase 3 trials for the treatment of Parkinson's disease .