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AbbVie's Emraclidine Fails in Schizophrenia Trials, Analysts Still Bullish on Immunology Portfolio

• AbbVie's emraclidine failed to meet the primary endpoint in two Phase 2 trials for schizophrenia, showing no statistically significant improvement in PANSS scores compared to placebo. • Analysts suggest Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) is now positioned to face less competition in the schizophrenia market following AbbVie's setback. • Despite the disappointing results, analysts maintain a positive outlook on AbbVie, emphasizing the strength and growth potential of its immunology franchise. • The failure raises questions about AbbVie's neuroscience strategy, though the company's acquisition of Cerevel still holds promise with Tavapadon showing positive Phase 3 results in Parkinson's disease.

AbbVie's stock experienced a downturn following the announcement that emraclidine, a once-daily, oral monotherapy being investigated for the treatment of schizophrenia, failed to meet its primary endpoint in two Phase 2 trials. The trials aimed to demonstrate a statistically significant improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at week 6, but neither study achieved this goal.
The failure of emraclidine has led analysts to reassess the competitive landscape in schizophrenia treatment. Truist analysts noted that Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride), is now likely to encounter less commercial rivalry. This outcome also prompts questions regarding AbbVie's strategic direction in neuroscience, an area that was previously highlighted during the company's third-quarter earnings call.

Analyst Reactions and Portfolio Confidence

Despite the setback, Truist maintains a Buy rating for AbbVie with a price target of $215, expressing confidence in the company's growth prospects, particularly within its immunology (I&I) franchise. Similarly, BMO Capital Markets acknowledged the disappointment, stating, "AbbVie core I&I thesis intact, but this one stings." BMO has reduced its price target for AbbVie from $228 to $208 but retains an Outperform rating, underscoring continued faith in the immunology portfolio.
BMO Capital Markets has significantly reduced the probability of success for emraclidine to 0%, previously estimating potential global peak sales of $3.9 billion for the drug in the schizophrenia indication.

Cerevel Acquisition and Parkinson's Pipeline

Emraclidine was a key asset acquired through AbbVie's acquisition of Cerevel. The acquisition also included Tavapadon, which recently reported positive Phase 3 results for Parkinson’s disease. In pivotal trials, patients treated with tavapadon experienced a statistically significant reduction (improvement) from baseline compared to placebo (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2 versus placebo) in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.

Competitive Landscape in Schizophrenia

Neurocrine Biosciences' NBI-1117568 has shown some efficacy in mixed phase 2 data, however, AbbVie's trials showed absolutely no benefit. Bristol Myers Squibb’s Cobenfy is now poised to dominate the schizophrenia market, according to analysts.
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Reference News

[1]
AbbVie's Schizophrenia Failure Disappoints But Analysts Show Confidence In Immunology Portfolio
benzinga.com · Nov 12, 2024

AbbVie Inc's emraclidine failed two Phase 2 trials for schizophrenia, impacting Bristol Myers Squibb's Cobenfy competiti...

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