**FDA Approves Bristol Myers Squibb's Revolutionary Schizophrenia Drug, Cobenfy**

In a landmark development for mental health treatment, the U.S. Food and Drug Administration has approved Bristol Myers Squibb's innovative drug, Cobenfy, marking the first new class of schizophrenia treatment in over three decades. This oral medication, comprised of xanomeline and trospium chloride (KarXT), is designed for adult patients and introduces a novel pharmacological approach by selectively targeting M1 and M4 receptors in the brain without interfering with D2 receptors.

The approval of Cobenfy is backed by robust data from the EMERGENT clinical trials, which included three placebo-controlled studies and two open-label studies to assess long-term safety and tolerability. In the Phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy achieved its primary endpoint, showing statistically significant reductions in symptoms of schizophrenia as assessed by the Positive and Negative Syndrome Scale (PANSS). Specifically, Cobenfy demonstrated a PANSS total score reduction of 9.6 points in EMERGENT-2 and 8.4 points in EMERGENT-3 compared to the placebo after five weeks.

The development and eventual acquisition of Cobenfy were part of a $14 billion deal between Bristol Myers Squibb and Karuna Therapeutics. Bristol Myers Squibb acquired the treatment for $330 per share in cash, reflecting a significant investment in advancing mental health solutions. PureTech Health Plc, where Cobenfy was initially invented, will receive milestone payments totaling $29 million following the FDA approval.

Chris Boerner, the board chair and CEO of Bristol Myers Squibb, highlighted the groundbreaking nature of the approval, expressing optimism that it would shift the treatment paradigm for the schizophrenia community after such a prolonged period without new pharmacological advancements.

The announcement has positively impacted Bristol Myers Squibb’s stock, which saw a 6.34% increase to $53.30 in the premarket session on Friday, underscoring the market’s confidence in this new treatment option.