Bristol Myers Squibb (NYSE:BMY) said its newly approved schizophrenia therapy, Cobenfy, improved disease symptoms with a well-tolerated safety profile over 12 months across two Phase 3 trials.

In September, the FDA approved the drug previously known as KarXT as a novel antipsychotic therapy for adults with schizophrenia.

Bristol-Myers (NYSE:BMY) added the drug in March following its $14B acquisition of Karuna Therapeutics, which initially developed the drug in partnership with Massachusetts-based PureTech Health (PRTX) and Royalty Pharma (RPRX).

Citing new topline data from its 52-week open-label studies, EMERGENT-4 and EMERGENT-5, Bristol-Myers (BMY) said long-term therapy with Cobenfy improved schizophrenia symptoms across all efficacy measures.

While there were no new safety or tolerability issues, discontinuation rates due to treatment-related or treatment-emergent adverse events (TEAE) stood at 11% and 18% in EMERGENT-4 and EMERGENT-5, respectively.

The 52-week EMERGENT-4 trial was designed to evaluate the long-term tolerability and efficacy of Cobenfy in 156 adults with schizophrenia who had previously received the drug as part of the company’s five-week EMERGENT-2 or EMERGENT-3 Phase 3 trials.

Meanwhile, 566 adults who had stable symptoms following prior antipsychotic therapy other than Cobenfy took part in the 52-week EMERGENT-5 trial.