Schizophrenia pipeline: two PDUFA dates and a dozen readouts in 2024

While all eyes will be on the muscarinic therapies that promise to add a new mechanism to the psychiatrist toolkit for treating schizophrenia, those are only the start of 2024’s milestones that will shed light on a wide array of new approaches to the disease. The year should bring a steady stream of clinical data that includes mechanisms for balancing excitation and inhibition in the brain, plus new ways to modulate serotonin and dopamine signaling. An epigenetic modulator and a digital therapeutic also have near-term readouts.

One highlight will undoubtedly be the Sept. 26 PDUFA date for KarXT, the therapy driving the $14 billion acquisition of  Karuna Therapeutics Inc. (NASDAQ:KRTX) by Bristol Myers Squibb Co. (NYSE:BMY). By combining the centrally acting M1/M4 receptor agonist xanomeline with the peripherally restricted muscarinic receptor antagonist trospium, KarXT delivers the efficacy of xanomeline without the side effects that initially prevented its development...