Schizophrenia Treatment Revolution: FDA Approves Bristol Myers Squibb's Cobenfy As First New Class Of Treatment In More Than 3 Decades

On Thursday, the FDA approved Bristol Myers Squibb & Co’s BMY Cobenfy (xanomeline and trospium chloride, KarXT), an oral medication for schizophrenia in adults.

Bristol-Myers added the treatment via Karuna Therapeutics deal for $330 per share in cash for a total equity value of $14 billion.

Cobenfy represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M1 and M4 receptors in the brain without blocking D2 receptors.

“Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” said Chris Boerner, board chair and CEO at Bristol Myers Squibb.

Schizophrenia is estimated to impact approximately 2.8 million people in the U.S.

The FDA approval of Cobenfy is supported by data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of COBENFY for up to one year.

In Phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) total score change from baseline to week five.

Cobenfy demonstrated a 9.6-point reduction (-21.2 Cobenfy vs. -11.6 placebo) and an 8.4-point reduction (-20.6 Cobenfy vs. -12.2 placebo) in PANSS total score compared to placebo at week five in EMERGENT-2 and EMERGENT-3, respectively.

In EMERGENT-2, Cobenfy demonstrated a statistically significant improvement in illness from baseline to week five.

Cobenfy was invented at PureTech Health Plc PRTC. FDA approval triggers two separate milestone payments to PureTech totaling $29 million.

Price Action: BMY stock is up 6.34% at $53.30 during the premarket session at last check Friday.

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