AbbVie Seeks FDA Nod for Tavapadon to Treat Parkinson's Disease

AbbVie ABBV announced that it has submitted a regulatory filing with the FDA, which seeks approval for its investigational drug tavapadon as a once-daily oral treatment for Parkinson’s disease (PD).

The FDA filing is supported by results from three late-stage studies — TEMPO-1, TEMPO-2 and TEMPO-3 — which demonstrated symptomatic improvement across a broad PD population. While TEMPO-1 and TEMPO-2 studies showed that tavapadon significantly reduced disease burden in early PD patients, TEMPO-3 results highlighted benefits when the drug was used as an add-on to levodopa, the current standard of care for PD symptoms.

If approved, tavapadon would represent AbbVie’s second recent FDA clearance in the PD indication, further reinforcing its presence in the space. Last year in October, the FDA approved Vyalev as the first and only subcutaneous 24-hour continuous infusion of carbidopa and levodopa prodrugs to treat motor fluctuations in advanced PD.

A novel first-in-class dopamine D1/D5 selective partial agonist, tavapadon was added to AbbVie’s pipeline following the acquisition of Cerevel Therapeutics for around $8.7 billion, which was completed last year.

ABBV Stock Performance

Year to date, shares of AbbVie have surged 24% against the industry‘s 2% decline.

ABBV’s Growing Neuroscience Portfolio

Over the years, the company has built a robust neuroscience segment. The franchise was initially led by blockbuster medications like Botox Therapeutic and the depression drug Vraylar. The company has since broadened its offerings to include migraine drugs Qulipta and Ubrelvy, and most recently, Vyalev.

Sales from the neuroscience franchise now account for over 17% of the company’s total revenues. The segment’s sales rose nearly 21% year over year in the first half of 2025, driven by higher sales of Botox Therapeutic and Vraylar, combined with the increasing uptake for Ubrelvy and Qulipta.

AbbVie continues to invest in new and promising therapies in the neuroscience space. It recently entered into a definitive agreement to acquire Gilgamesh Pharmaceuticals’ lead pipeline drug for a total deal value of nearly $1.2 billion. Once closed, the deal will add Gilgamesh’s novel psychedelic compound, which is being developed in a mid-stage study for major depressive disorder (MDD). This follows the $1.4 billion acquisition of Aliada Therapeutics, completed in December, which added an investigational antibody for Alzheimer’s disease.

However, the franchise has also faced setbacks. Apart from tavapadon, the Cerevel acquisition brought emraclidine into AbbVie’s pipeline, but development was discontinued after the drug failed two registration-enabling phase II studies in schizophrenia. This setback was a huge disappointment for the company as emraclidine was a key reason for buying Cerevel, raising questions about the viability of the deal. Post the failure, the company also recorded a $3.5 billion impairment charge

ABBV’s Zacks Rank

AbbVie currently carries a Zacks Rank #3 (Hold).

AbbVie Inc. Price

 

AbbVie Inc. price | AbbVie Inc. Quote

Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are ANI Pharmaceuticals ANIP, argenx ARGX and Halozyme Therapeutics HALO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, EPS estimates for ANI Pharmaceuticals’ 2025 have risen from $6.55 to $7.28. EPS estimates for 2026 have increased from $7.08 to $7.78 during the same period. ANIP stock has soared over 68% year to date.

ANI’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 22.66%.

argenx's EPS estimates for 2025 have significantly increased from $12.75 to $15.74 in the past 60 days. During the same timeframe, EPS estimates for 2026 have risen from $20.29 to $23.87. ARGX stock has risen nearly 16% so far this year.

argenx’s earnings beat estimates in three of the trailing four quarters while missing the mark on one occasion, delivering an average surprise of 329.81%.

Halozyme Therapeutics’ EPS estimates for 2025 have risen from $5.48 to $6.18 in the past 60 days. During the same timeframe, EPS estimates for 2026 have increased from $6.43 to $7.57. HALO stock has surged over 54% so far this year.

Halozyme’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.74%.

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This article originally published on Zacks Investment Research (zacks.com).

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