AstraZeneca (AZN) and Targacept Inc. (TRGT) recently announced top-line results from the remaining RENAISSANCE phase III efficacy and tolerability trials evaluating TC-5214. TC-5214 was being evaluated as an adjunct treatment for major depressive disorder (MDD) patients who have not responded adequately to initial antidepressant therapy. Both RENAISSANCE 4 and RENAISSANCE 5 failed to meet their primary endpoints.
A separate study, RENAISSANCE 7, evaluating the safety of TC-5214 in combination with an antidepressant treatment, found that the candidate was well tolerated with a safety profile consistent with earlier clinical trials.
Following the disappointing results, AstraZeneca and Targacept no longer plan to file for approval of TC-5214.
Last year, AstraZeneca and Targacept had reported negative top-line results from the first two RENAISSANCE phase III studies. Following this, AstraZeneca had incurred an intangible asset impairment charge of $150 million related to TC-5214. The company will take another intangible asset impairment charge of $50 million, which represents the remaining value of TC-5214.
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