Terran Biosciences prepares for trials of schizophrenia drug [Yahoo! Finance]
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Bristol-Myers Squibb Company (BMY)
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Source: Yahoo! Finance
Terran Biosciences CEO Sam Clark told the Clinical Trials Arena that TerXT is a long-acting pro-drug of Bristol Myers Squibb's (BMS) KarXT, a combination of xanomeline and trospium. KarXT was originally developed by Karuna Therapeutics until BMS acquired the company in a $14bn deal. KarXT is yet to be approved by the US Food and Drug Administration (FDA) but a PDUFA date is set for 26 September. The therapy is the first potential new pharmacological approach for treating schizophrenia in over 50 years. TerXT is a once-daily oral candidate while TerXT LAI is a multi-month injectable candidate. Both use the same candidates as KarXT, which is a twice-daily oral drug, but is longer-acting. Terran is looking to launch two Phase I trials soon, one for each of the candidates to confirm safety and pharmacokinetics, with Clark adding that due to the regulatory pathway the company is utilising, these will be the only studies required for these candidates. Each trial will enrol approx
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