CLAIM #2722 · AbbVie Inc (ABBV) · 2025Q4 earnings call · Feb 4, 2026 · due Sep 30, 2026
“Turning to neuroscience, in our movement disorder programs, an approval decision is anticipated in the third quarter for tevapadon in Parkinson's disease.”
Roopal Thakkar · Chief Scientific Officer
How to check this claim
Look at: FDA approval decision status for tevapadon (Parkinson's disease)
It came true if: FDA issues an approval decision (approval or complete response letter) for tevapadon between 2026-07-01 and 2026-09-30
Where: Company press release / FDA announcement / 10-Q or earnings call commentary
In context
“recently began in treatment-naive patients. A phase three study in second-line plus patients is also planned to initiate this year. In hematologic malignancies, the regulatory application for PIVC in blastic plasmacytoid dendritic cell neoplasm is under review with the FDA. An approval decision is anticipated later this year. Enrollment is projected to complete this quarter in our phase three trial evaluating monotherapy atentamig in third-line plus multiple myeloma, with an objective response rate readout anticipated in the second half of this year. A phase two study of ententamig plus daratumumab in frontline transplant-ineligible patients was recently initiated. Additionally, a phase three study in second-line evaluating entantamig with pomalidomide is expected to begin by early 2027. Turning to neuroscience, in our movement disorder programs, an approval decision is anticipated in the third quarter for tevapadon in Parkinson's disease. As a highly effective treatment for motor symptoms, with low rates of dyskinesia, edema, sedation, and impulse control disorder, tevapadon has the potential to be an important new treatment option, both as a monotherapy and as an adjunct to levocarbidopa in patients still experiencing motor fluctuations. This year, a phase two study assessing gemmibot A in essential tremor will begin. Essential tremor is the most common movement disorder and an area with considerable need for effective and tolerable therapies. Unlike most patients with spasticity, patients with essential tremor typically have normal strength. Therefore, it is important that neighboring muscles are not inadvertently affected, and this is by toxin diffusion. Our new toxin is highly potent and has the potential for less spre”
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SEC filings for ABBV ↗ · Claim quote is verbatim from the 2025Q4 earnings call.