AbbVie’s ABBV mid-stage studies of emraclidine for schizophrenia failed to meet their primary endpoint. Shares of the company lost 12.6% on Monday in response to the disappointing news. However, Bristol Myers’ BMY stock was up 10.5% following ABBV’s news.
The studies were designed to show a statistically significant reduction (improvement) in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score upon treatment with the candidate compared with the placebo group at week 6. Please note that PANSS is a metric that measures the symptom severity of schizophrenia.
The two phase II EMPOWER studies evaluated emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms. Emraclidine is a potential novel M4-selective PAM in development for schizophrenia and Alzheimer's disease psychosis as a once-daily medication without the need for titration. Year to date, shares of AbbVie have gained 12.6% compared with the industry’s 11.5% growth.
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ABBV reported that the candidate was overall well-tolerated in the EMPOWER studies, demonstrating a safety profile consistent with that observed in a previous early-stage study. Adverse events related to treatment with emraclidine were mostly mild-to-moderate in severity. Currently, AbbVie plans to analyze these results further to determine the next steps in the development process of the candidate for the schizophrenia indication.
We remind the investors that emraclidine was added to AbbVie’s neuroscience pipeline through the acquisition of Cerevel. The transaction also added several other clinical-stage and preclinical candidates being developed for neurological indications like psychiatry, migraine and Parkinson's disease.
AbbVie Inc. price-consensus-chart | AbbVie Inc. Quote
AbbVie was developing emraclidine to rival Bristol Myers’ Cobenfy (xanomeline and trospium chloride), also an oral medication for the treatment of schizophrenia in adults, which was approved by the FDA in September 2024. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which have long been the standard of care.
However, BMY’s Cobenfy has a different mechanism of action than ABBV’s emraclidine. Cobenfy is aimed at treating schizophrenia by selectively targeting M 1 and M 4 receptors in the brain without blocking D 2 receptors. Year to date, shares of Bristol Myers have gained 16.4% against the industry’s 1.2% decline.
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The failure of the EMPOWER studies is a huge benefit for Bristol Myers as it reduces emerging competition for Cobenfy, which could have resulted in the stock price rise on Monday. Bristol Myers had acquired Cobenfy from the acquisition of Karuna Therapeutics.
Bristol Myers Squibb Company price-consensus-chart | Bristol Myers Squibb Company Quote
AbbVie currently carries a Zacks Rank #2 (Buy), while Bristol Myers has a Zacks Rank #3 (Hold).
Some other top-ranked pharma stocks are Allogene Therapeutics ALLO and Biogen BIIB, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Allogene Therapeutics’ loss estimates have remained constant at $1.41 per share for 2024 over the past 60 days, while that for 2025 has narrowed from $1.46 to $1.45 per share. ALLO’s shares have lost 3.7% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.
Biogen’s earnings estimates have risen from $16.12 to $16.38 per share for 2024 over the past 60 days, while that for 2025 has increased from $17.09 to $17.16. BIIB’s shares have lost 33.5% year to date.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 9.99%.
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