AbbVie ABBV introduced that it has submitted a regulatory submitting with the FDA, which seeks approval for its investigational drug tavapadon as a once-daily oral remedy for Parkinson’s illness (PD).
The FDA submitting is supported by outcomes from three late-stage research — TEMPO-1, TEMPO-2 and TEMPO-3 — which demonstrated symptomatic enchancment throughout a broad PD inhabitants. Whereas TEMPO-1 and TEMPO-2 research confirmed that tavapadon considerably decreased illness burden in early PD sufferers, TEMPO-3 outcomes highlighted advantages when the drug was used as an add-on to levodopa, the present customary of take care of PD signs.
If permitted, tavapadon would signify AbbVie’s second latest FDA clearance within the PD indication, additional reinforcing its presence within the house. Final yr in October, the FDA permitted Vyalev as the primary and solely subcutaneous 24-hour steady infusion of carbidopa and levodopa prodrugs to deal with motor fluctuations in superior 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 round $8.7 billion, which was accomplished final yr.
ABBV Inventory Efficiency
Yr to this point, shares of AbbVie have surged 24% in opposition to the trade‘s 2% decline.
Picture Supply: Zacks Funding Analysis
ABBV’s Rising Neuroscience Portfolio
Through the years, the corporate has constructed a strong neuroscience phase. The franchise was initially led by blockbuster medicines like Botox Therapeutic and the melancholy drug Vraylar. The corporate has since broadened its choices to incorporate migraine medication Qulipta and Ubrelvy, and most just lately, Vyalev.
Gross sales from the neuroscience franchise now account for over 17% of the corporate’s whole revenues. The phase’s gross sales rose almost 21% yr over yr within the first half of 2025, pushed by greater gross sales of Botox Therapeutic and Vraylar, mixed with the growing uptake for Ubrelvy and Qulipta.
AbbVie continues to put money into new and promising therapies within the neuroscience house. It just lately entered right into a definitive settlement to accumulate Gilgamesh Prescription drugs’ lead pipeline drug for a complete deal worth of almost $1.2 billion. As soon as closed, the deal will add Gilgamesh’s novel psychedelic compound, which is being developed in a mid-stage examine for main depressive dysfunction (MDD). This follows the $1.4 billion acquisition of Aliada Therapeutics, accomplished in December, which added an investigational antibody for Alzheimer’s illness.
Nonetheless, the franchise has additionally confronted setbacks. Aside from tavapadon, the Cerevel acquisition introduced emraclidine into AbbVie’s pipeline, however growth was discontinued after the drug failed two registration-enabling part II research in schizophrenia. This setback was an enormous disappointment for the corporate as emraclidine was a key purpose for purchasing Cerevel, elevating questions concerning the viability of the deal. Submit the failure, the corporate additionally recorded a $3.5 billion impairment cost
ABBV’s Zacks Rank
AbbVie at present carries a Zacks Rank #3 (Maintain).
AbbVie Inc. Worth
AbbVie Inc. worth | AbbVie Inc. Quote
Key Picks Amongst Biotech Shares
Some better-ranked shares from the sector are ANI Prescription drugs ANIP, argenx ARGX and Halozyme Therapeutics HALO, every sporting a Zacks Rank #1 (Sturdy Purchase) at current. You possibly can see the whole listing of immediately’s Zacks #1 Rank shares right here.
Prior to now 60 days, EPS estimates for ANI Prescription drugs’ 2025 have risen from $6.55 to $7.28. EPS estimates for 2026 have elevated from $7.08 to $7.78 throughout the identical interval. ANIP inventory has soared over 68% yr to this point.
ANI’s earnings beat estimates in every of the trailing 4 quarters, delivering a mean shock of twenty-two.66%.
argenx’s EPS estimates for 2025 have considerably elevated from $12.75 to $15.74 previously 60 days. Throughout the identical timeframe, EPS estimates for 2026 have risen from $20.29 to $23.87. ARGX inventory has risen almost 16% up to now this yr.
argenx’s earnings beat estimates in three of the trailing 4 quarters whereas lacking the mark on one event, delivering a mean shock of 329.81%.
Halozyme Therapeutics’ EPS estimates for 2025 have risen from $5.48 to $6.18 previously 60 days. Throughout the identical timeframe, EPS estimates for 2026 have elevated from $6.43 to $7.57. HALO inventory has surged over 54% up to now this yr.
Halozyme’s earnings beat estimates in every of the trailing 4 quarters, delivering a mean shock of 19.74%.
5 Shares Set to Double
Every was handpicked by a Zacks professional as the favourite inventory to realize +100% or extra within the months forward. They embody
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Inventory #2: Bullish Indicators Signaling to Purchase the Dip
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Inventory #5: Fashionable Omni-Channel Platform Coiled to Spring
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Halozyme Therapeutics, Inc. (HALO) : Free Inventory Evaluation Report
AbbVie Inc. (ABBV) : Free Inventory Evaluation Report
ANI Prescription drugs, Inc. (ANIP) : Free Inventory Evaluation Report
argenex SE (ARGX) : Free Inventory Evaluation Report
This text initially revealed on Zacks Funding Analysis (zacks.com).
The views and opinions expressed herein are the views and opinions of the writer and don’t essentially mirror these of Nasdaq, Inc.
