The FDA will respond to the New Drug Application for Bristol Myers Squibb and Karuna Therapeutic’s schizophrenia drug, KarXT, by September 26, 2024. KarXT, a muscarinic M1/M4 agonist, shows promise in reducing schizophrenia symptoms without metabolic, endocrine, or motor adverse effects, potentially positioning it as a first-line treatment alongside standard serotonin/dopamine antagonists.