Bristol Myers Squibb announces merger with Karuna Therapeutics
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Bristol Myers Squibb and Karuna Therapeutics Inc. announced a definitive merger agreement that includes Karuna’s lead asset, a muscarinic receptor agonist to treat schizophrenia and Alzheimer’s disease psychosis.
According to a press release from Bristol Myers Squibb, the new drug application for KarXT (xanomeline-trospium, Karuna) was accepted for review by the FDA and given a Prescription Drug User Fee Act date of Sept. 26, 2024.
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“There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio,” Bristol Myers Squibb CEO Christopher Boerner, PhD, stated in the release. “This transaction fits squarely within our business development priorities of pursuing assets that are strategically aligned, scientifically sound, financially attractive and have the potential to address areas of significant unmet medical need.”
The release further stated that KarXT is expected to launch in late 2024 as a treatment for schizophrenia in the U.S., while a registrational clinical trial is currently ongoing to evaluate KarXT as adjunctive treatment for those with schizophrenia, with data expected in 2025.
Also according to the company, registrational clinical trials are currently underway evaluating KarXT to address AD psychosis, with data from these studies expected in 2026.
Bristol Myers Squibb additionally stated it would investigate KarXT’s potential to treat such conditions as bipolar I disorder.
“With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale and legacy in neuroscience, KarXT and the other assets in our pipeline will be well-positioned to reach those living with schizophrenia and Alzheimer’s disease psychosis,” Karuna President and CEO Bill Meury, said in the release.