Bristol Myers Squibb (BMS) announced on Friday it will pay $14 billion in cash to acquire Karuna Therapeutics, a developer of therapeutics targeting psychiatric and neurological conditions. Karuna’s lead candidate KarXT (xanomeline-trospium) is a potential first-in-class drug that has demonstrated differentiated safety and efficacy in adult schizophrenia with additional indications in schizophrenia and Alzheimer’s disease (AD) psychosis along with other neurodegenerative and neuropsychiatric indications.
“There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space,” said Christopher Boerner, PhD, CEO of BMS. “We expect KarXT to enhance our growth through the late 2020s and into the next decade. 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.”
Karuna’s NDA for KarXT for the treatment of schizophrenia in adults was accepted for review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease. Bristol Myers Squibb believes KarXT represents a significant revenue contribution opportunity.
KarXT targets both the M1 and M4 muscarinic receptors, which are involved in the regulation of acetylcholine. The M1 muscarinic receptor has long been identified as a potential therapeutic target for AD based on its role in memory and learning processes. KarXT has exhibited improvements in cognition in clinical trials and has not produced many of the side effects associated with other classes of drugs in this therapeutic area including weight gain, extrapyramidal symptoms, increased prolactin levels, akathisia and/or sedation.
“Schizophrenia and (AD) psychosis affect millions of people worldwide, with limited to no treatment options. KarXT’s novel mechanism has resulted in a transformational profile in schizophrenia, with compelling efficacy and a differentiated safety profile,” said Samit Hirawat, MD, executive vice president and CMO of Drug Development at BMS. “KarXT also has the potential to deliver meaningful benefits to patients as an adjunctive treatment for patients with schizophrenia and as a first treatment for Alzheimer’s disease psychosis.”
Specifically, BMS noted the following known schizophrenia and AD pathways for KarXT:
- Schizophrenia: KarXT is expected to launch in late 2024 in the U.S. as a treatment for schizophrenia in adults. There are approximately 1.6 million people treated for schizophrenia in the U.S., a significant portion of whom do not respond to currently available therapies and experience unacceptable side effects.
- Adjunctive schizophrenia: A current registrational clinical trial is evaluating KarXT as adjunctive treatment with current standard of care agents for the treatment of schizophrenia, with data expected in 2025.
- Alzheimer’s disease psychosis: Registrational clinical trials are currently underway evaluating KarXT for the treatment of Alzheimer’s disease psychosis, with data expected in 2026. There are more than six million people living with Alzheimer’s disease in the U.S. There are currently no approved treatments for Alzheimer’s disease psychosis.
- Additional indications: BMS believes KarXT also has potential in additional indications, including Bipolar I disorder, which impacts approximately 1.4 million people in the U.S., and Alzheimer’s disease agitation.
“Karuna’s portfolio offers advancements in treatment not seen in many years,” noted Karuna’s president and CEO Bill Meury. “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’s pipeline also includes TRPC4/5 inhibitor KAR-2618 (formerly GFB-887) in licensed from Goldfinch Bio for anxiety and mood disorder indications currently in a Phase I trial and four other candidates in preclinical development for undisclosed indications.
