In the Phase 3 TEMPO program, AbbVie’s Juvmo elicited significant improvements in motor symptoms and prolonged periods with good symptom control.
AbbVie may have struck out with the high-profile schizophrenia asset it got from its $8.7 billion acquisition of Cerevel Therapeutics, but a Parkinson’s candidate that came with the deal has now made it to market.
The drug tavapadon has been approved by the FDA for adults with Parkinson’s disease and will carry the brand name Juvmo, according to the agency’s website. BioSpace has reached out to AbbVie regarding the pharma’s pricing and launch plans.
AbbVie announced its acquisition of Cerevel in December 2023 and closed the deal in August 2024. The star of that deal was the next-generation antipsychotic therapy emraclidine, which failed a mid-stage schizophrenia study in November 2024, dragging the pharma’s shares down 12% at the time.
Juvmo’s approval was backed by data from the Phase 3 pivotal TEMPO program. Just weeks after emraclidine’s failure, the late-stage TEMPO-2 trial showed that patients on Juvmo saw significant improvements in motor and daily living complications as compared to placebo—the trial’s primary endpoint.
Juvmo had also previously cleared two other studies under the TEMPO program. In April 2024, before the Cerevel acquisition closed, TEMPO-3 data pointed to a significantly better total “on” time in patients treated with Juvmo, the study’s primary endpoint. In Parkinson’s disease, “on” time refers to periods of good symptom control and patient function.
TEMPO-1 read out in September 2024 and likewise showed that Juvmo hit its primary endpoint of improving motor function versus placebo. After the trio of trial successes, AbbVie filed for approval in September 2025.
With Juvmo’s approval, AbbVie could now gain access to a $5 billion market opportunity, Chief Commercial Officer Jeffrey Stewart said during the company’s Q2 earnings call in July. “There’s nothing else like it in the marketplace,” he said of the drug. Unlike other medicines for Parkinson’s disease—including the gold-standard dopamine replacement therapy levodopa—Juvmo is less likely to cause sedation, or what Stewart calls “sleep attacks.”
“Parkinson’s has been a very difficult field for pharma as a whole to approach,” Jefferies equity analyst Alyna Shamsi told BioSpace earlier this month, pointing to challenges such as late diagnosis, slow progression and a different biological presentation across patients.
Recently, this difficulty has manifested as a string of pipeline setbacks, including BioVie’s murky mid-stage readout last month. The biotech touted significant motor and non-motor improvements but these were based on an alternative endpoint, and BioVie’s stock crashed 50% at the time. And back in May, Biogen and Denali Therapeutics discontinued the investigational Parkinson’s therapy BIIB112 after it failed to slow disease progression in a Phase 2b study.
