On Monday, AbbVie Inc (NYSE:ABBV) stock is trading lower after it released data from its two Phase 2 EMPOWER trials of emraclidine for schizophrenia.
The trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia. The patients experienced an acute exacerbation of psychotic symptoms and did not meet their primary endpoint of showing a statistically significant improvement in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6.
PANSS is a scale used for measuring the symptom severity of schizophrenia.
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"While we are disappointed with the results, we are continuing to analyze the data to determine next steps," said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie.
The EMPOWER clinical development program evaluated emraclidine in patients with schizophrenia who are experiencing an acute exacerbation in two adequately powered, placebo-controlled Phase 2 trials, EMPOWER-1 and EMPOWER-2.
The program also includes a 52-week open-label extension trial EMPOWER-3 evaluating emraclidine in people living with schizophrenia who have stable symptoms and are not currently experiencing an acute exacerbation of psychotic symptoms.
AbbVie added emraclidine via the approximately $8.7 billion acquisition of Cerevel Therapeutics.
Last year, an analyst highlighted that the Cerevel deal aligns seamlessly with its established strategy, introducing a portfolio of five clinical-stage and two preclinical candidates targeting various ailments like schizophrenia, Parkinson's disease, and mood disorders.
This strategic move is anticipated to fuel growth from the latter part of this decade well into the 2030s.
Last month, the FDA approved AbbVie's Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for motor fluctuations in adults with advanced Parkinson's disease.
Most recently, the FDA approved Bristol Myers Squibb & Co's (NYSE: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.
Price Action: AbbVie stock is down 10.6% at $178.32, while Bristol Myers Squibb stock is up 13% at $61.20 during the premarket session at last check Monday.
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