Karuna Therapeutics announced positive topline results from its Phase 3 EMERGENT-3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT in adults with schizophrenia. The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale total score compared to placebo at Week 5. Consistent with prior trials, KarXT demonstrated an early and sustained statistically significant reduction of symptoms from Week 2 through the end of the trial as assessed by PANSS total score. The NDA submission for KarXT in schizophrenia will incorporate the efficacy and safety data from the three placebo-controlled registrational trials, EMERGENT-1, EMERGENT-2, and EMERGENT-3, in addition to long-term safety data from the ongoing EMERGENT-4 and EMERGENT-5 trials. The company is on track to submit an NDA to the FDA in mid-2023, with a potential launch in the second half of 2024, if approved.
Published first on TheFly
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