Emraclidine was the centerpiece of AbbVie’s $8.7 billion acquisition of Cerevel in December 2023 but failed two mid-stage trials. Tavapadon, meanwhile, has been a more rewarding asset for the pharma, clearing three Phase III Parkinson’s studies in 2024.
AbbVie will take an impairment charge of approximately $3.5 billion related to the back-to-back failures of its pricey drug candidate emraclidine in two mid-stage schizophrenia trials, the pharma revealed in a Friday SEC filing.
“Following the results of these trials, AbbVie began an evaluation of the emraclidine intangible asset for impairment which resulted in a significant decrease in the estimated future cash flows for the product,” the pharma stated in its SEC document. “Based on the revised cash flows, the company estimates a non-cash after-tax intangible asset impairment charge of approximately $3.5 billion.”
The multi-billion write-down comes after AbbVie in November 2024 reported that its two Phase II EMPOWER studies failed to hit the primary efficacy endpoint, which in both cases was a change from baseline on the Positive and Negative Syndrome Scale. The first study, dubbed EMPOWER-1, documented only a slight improvement in scores versus placebo, whereas EMPOWER-2 found that the lower emraclidine dose led to an increase in scores—indicating worsening symptoms.
AbbVie’s stock tanked 12% in the aftermath of the failure.
Emraclidine is a next-generation antipsychotic drug candidate that works as a positive allosteric modulator of the muscarinic M4 receptor. Aside from the two schizophrenia studies, AbbVie is also running a Phase I trial of the compound in Alzheimer’s disease psychosis.
AbbVie gained ownership of emraclidine in December 2023 when it dropped $8.7 billion to acquire neuro leader Cerevel Therapeutics. According to the pharma’s SEC filing on Friday, the remaining assets from this buyout are valued at about $3.6 billion. “AbbVie continues to evaluate information with respect to the Cerevel-related clinical development program,” the company wrote.
Of these remaining assets, the Parkinson’s disease therapy tavapadon appears to have the most promise, hitting its key efficacy endpoint in the Phase III TEMPO-1 study in September 2024. At 26 weeks, 5 mg of tavapadon improved combined scores on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale by 9.7 points, indicating better motor performance. Tavapadon also met the secondary endpoints in TEMPO-1, showing improved motor experiences of daily living.
In December 2024—a month after emraclidine’s stunning schizophrenia stumble—AbbVie again posted positive data for tavapadon, showing significant improvements in motor function and daily living complications in the Phase III TEMPO-2 study. Tavapadon likewise aced the late-stage TEMPO-3 trial in April 2024.
