Karuna Announces Positive Trial Results for Schizophrenia Drug, Raises $460 Million via Stock Offering

Boston-based Karuna Therapeutics, a clinical-stage biopharma with a focus on psychiatric and neurological conditions, has announced positive topline results from its Phase 3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium) in adults with schizophrenia. The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful improvement compared to placebo. Consistent with prior trials, KarXT demonstrated an early and sustained statistically significant reduction of symptoms from Week 2 through the end of the trial.

“With these data, we are one step closer to a potential treatment option that could provide the first new mechanism of action to treat schizophrenia in several decades,” said Bill Meury, Karuna’s president and CEO. “We look forward to working closely with the FDA as we focus our attention on the regulatory process…and remain on track for an NDA submission in mid-2023.”

“The results…add to the growing body of data which suggest KarXT could address the symptoms of schizophrenia without the common side effects we see with current treatment options.” said David Walling, Ph.D., chief clinical officer at Cenexel – CNS and investigator on the trial.

KarXT (xanomeline-trospium) is in development for the treatment of psychiatric and neurological conditions, including schizophrenia and psychosis in Alzheimer’s disease. KarXT is the first potential medicine of its kind with a truly new and unique dual mechanism of action. Karuna is on track to submit an NDA to the FDA in mid-2023, with a potential launch in the second half of 2024, if approved.

In more good news for the company, Karuna announced it has closed its public Offering and full exercise of option to purchase additional shares. Gross proceeds to Karuna in the offering, before underwriting discounts and estimated expenses of the offering, were approximately $460 million. (Source: Karuna Therapeutics Website, 20 & 24 March, 2023)