Bristol Myers Squibb’s $14 Billion Bet Pays Off: FDA Approves Novel Schizophrenia Drug Cobenfy

FDA Approval:
The FDA has approved Bristol Myers Squibb's novel schizophrenia drug Cobenfy, marking the first innovative treatment for schizophrenia in over 70 years.

Acquisition Background:
Bristol Myers Squibb acquired Karuna Therapeutics, the developer of Cobenfy, in a $14 billion deal in December 2023.

Drug Mechanism:
Cobenfy targets the M1 and M4 muscarinic receptors in the central nervous system, offering a new approach to treating schizophrenia with potentially better tolerability compared to existing medications.

Clinical Trials:
The FDA approval was based on two Phase 3 trials that showed statistically significant reductions in schizophrenia symptoms compared to placebo.

Pricing and Availability:
Cobenfy will be priced at $1,850 per month, or $22,200 per year, and is expected to be available by late October 2024.

Market Potential:
Analysts predict that Cobenfy could achieve peak sales of $2 billion in 2030 for schizophrenia alone, with potential for additional indications such as Alzheimer’s-associated psychosis and adjunctive schizophrenia.

Competition:
Cobenfy will face competition from other muscarinic receptor-targeting drugs in development, including AbbVie’s emraclidine, which is expected to file for regulatory approval in the second half of 2025.