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CLAIM #2503 · AbbVie Inc (ABBV) · 2024Q4 earnings call · Jan 31, 2025 · due Dec 31, 2025

Longer term safety data will be available this year and regulatory submissions will then follow.

Roopal Thakkar · Chief Scientific Officer

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Committed
Longer term safety data will be available this year and regulatory submissions will then follow.
Reported
An approval decision is anticipated in the third quarter for tevapadon in Parkinson's disease.

In context

dies planned in 2026 in patients with psychosis related to Alzheimer's and Parkinson's Disease. Staying on the topic of Parkinson's Disease, positive top line results from the third Phase 3 trial for Tavapadon were recently announced. In the TEMPO-2 trial, Tavapadon met the primary endpoint, demonstrating a significant reduction in the severity of Parkinson's Disease symptoms compared with placebo at week 26. Key secondary endpoints were also achieved. We are very pleased with the emerging profile for Tavapadon, which shows strong efficacy as a monotherapy and as an add-on to Levo, Carbidopa. The six-month data from the Phase 3 studies show Tavapadon to be generally safe and well tolerated with low rates of adverse events of special interest, such as sedation and impulse control disorder. Longer term safety data will be available this year and regulatory submissions will then follow. Moving to aesthetics, we met with the FDA late last year regarding our BoNT/E submission for the treatment of glabellar lines. We are in the process of generating additional CMC data requested by the agency, which should be completed in the next few months. The regulatory submission will likely occur around the middle of the year. To summarize, there have been significant advancements across all stages of our pipeline. In 2025, we anticipate numerous important regulatory and clinical milestones, including many trial starts for key programs. With that, I'll turn the call over to Scott. Scott Reents: Thank you, Roopal. Starting with our fourth quarter results, we reported adjusted earnings per share of $2.16 which is $0.08 above our guidance midpoint. These results include an $0.88 unfavora

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SEC filings for ABBV · Claim quote is verbatim from the 2024Q4 earnings call.