The U.S. Food and Drug Administration (FDA) has granted official approval to Cobenfy (KarXT, xanomeline and trospium chloride) as an oral treatment for schizophrenia, marking it as the first therapy with a novel mechanism of action in this indication in several decades within the U.S.
KarXT, an oral M1/M4 type muscarinic agonist, was originally developed by Karuna Therapeutics, Inc. (NASDAQ: KRTX). It holds the potential to emerge as the first new drug featuring a dual mechanism that deviates from targeting the dopamine and serotonin signaling pathways. In November 2021, Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688), a Chinese pharmaceutical company, entered into a licensing agreement worth USD 187 million with Karuna, securing exclusive rights to develop and commercialize the drug in Greater China. Subsequently, in December 2023, U.S. pharmaceutical giant Bristol Myers Squibb (BMS; NYSE: BMY) acquired Karuna for a sum of USD 14 billion, integrating Cobenfy into its product portfolio.- Flcube.com
