AbbVie's Emraclidine Fails to Meet Primary Endpoint in Phase 2 Schizophrenia Trials

• AbbVie's emraclidine, an oral monotherapy for schizophrenia, did not achieve statistically significant improvement in two Phase 2 trials, causing AbbVie shares to decline.
• Despite the setback, AbbVie will continue analyzing the data to determine the next steps for emraclidine's development in psychiatric disorders.
• AbbVie's focus remains on its pipeline of innovative therapies, particularly after acquiring Cerevel Therapeutics for $8.7 billion to expand its offerings in schizophrenia treatment.
• Bristol-Myers Squibb's schizophrenia drug, Cobenfy (KarXT), recently gained FDA approval, following their acquisition of Karuna Therapeutics for $14 billion.

AbbVie (NYSE:ABBV) has announced that two Phase 2 trials of emraclidine, an investigational treatment for adults with schizophrenia, did not meet the primary endpoint. The trials assessed emraclidine as a once-daily oral monotherapy. The company's stock experienced a sharp decline in premarket trading following the announcement.

The studies failed to demonstrate a statistically significant improvement in patients treated with emraclidine compared to placebo. Roopal Thakkar, AbbVie Chief Scientific Officer, stated, "While we are disappointed with the results, we are continuing to analyze the data to determine next steps." AbbVie remains committed to developing treatments for psychiatric and neurological disorders.

AbbVie currently markets Vraylar, an antipsychotic drug, and has been actively expanding its pipeline of medicines for schizophrenia, highlighted by its $8.7 billion acquisition of Cerevel Therapeutics last year. This acquisition aimed to bolster AbbVie's position in the psychiatric therapeutics market.

In October, AbbVie raised its full-year income forecast, citing strong operational momentum after exceeding third-quarter net revenue estimates. CEO Robert Michael attributed this success to "significant pipeline progress," expressing confidence in the company's long-term growth prospects. AbbVie has been strategically building its pipeline since the loss of patent protection for its blockbuster arthritis drug, Humira.

Conversely, Bristol-Myers Squibb (NYSE:BMY) saw its shares rise following the news. The FDA recently approved Bristol-Myers Squibb's schizophrenia drug, Cobenfy (also known as KarXT), which they obtained through a $14 billion acquisition of Karuna Therapeutics in 2023.