BMS Phase III ARISE trial evaluating Cobenfy disappoints

US pharma major Bristol Myers Squibb (NYSE: BMY) saw its shares fall 4% in after-hours trading on Tuesday, after it announced disappointing top-line results from the Phase III ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with inadequately controlled symptoms of schizophrenia.

In the study, adjunctive Cobenfy treatment demonstrated a 2.0-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo with an atypical antipsychotic at Week 6, which did not reach the threshold for statistical significance for the primary endpoint (P = 0.11), said BMS.

The company has previously touted Cobenfy, which launched in the USA last year, as a significant growth driver with blockbuster potential, along with Reblozyl (luspatercept) Breyanzi (lisocabtagene maraleucel). The disappointing results could deal a blow to the company's hopes for the drug.