Biopharmaceutical company, Abbvie sign in front of Illinois offices.

AbbVie's Botox Shows Improvement In Movement Disorder Study

AbbVie Inc. (NYSE:ABBV) on Monday shared topline results from the Phase 2 ELATE trial evaluating onabotulinumtoxinA (BOTOX) compared to placebo for upper limb essential tremor.

Upper limb essential tremor is a progressive movement disorder characterized by rhythmic, involuntary shaking of the hands and arms, most pronounced during action or specific postures.

The study met its primary endpoint, demonstrating statistically significant improvements in the Tremor Disability Scale-Revised (TREDS-R) of onabotulinumtoxinA compared to placebo at week 18.

Specifically, the onabotulinumtoxinA group showed a greater reduction in TREDS-R total unilateral score compared to placebo, with scores of -2.61 versus -1.61 (p=0.029). The study also met all six secondary endpoints.

Safety results were generally consistent with the well-established safety profile of onabotulinumtoxinA.

“No new pharmacological treatments have been approved in the U.S. for essential tremor for more than 30 years. These results represent a significant advance and demonstrate further proof of mechanism for a neurotoxin as a potential treatment option…,” said Daniel Mikol, vice president, neuroscience development, AbbVie.

On Friday, AbbVie announced that reported GAAP earnings and adjusted non-GAAP earnings for the third quarter of 2025 are expected to include acquired IPR&D and milestone expenses of $2.7 billion on a pre-tax basis.

In an SEC filing, the drug maker stated that the expenses represent an unfavorable impact of $1.50 to GAAP earnings per share and adjusted earnings per share.

Also Read: Novartis, AbbVie Face Legal Defeat Over 340B Contract Pharmacies

AbbVie's full-year 2025 adjusted earnings per share guidance range, including the impact of third quarter 2025 acquired IPR&D and milestones expense, is $10.38 – $10.58.

During its second-quarter earnings release, AbbVie raised its fiscal 2025 adjusted earnings from $11.67-$11.87 per share to $11.88-$12.08, compared to the analysts' estimate of $12.24.

The guidance included an unfavorable impact of 55 cents per share related to acquired IPR&D and milestone expenses incurred year-to-date through the second quarter of 2025.

AbbVie's third-quarter 2025 adjusted diluted earnings per share guidance range, including the impact of third-quarter 2025 acquired IPR&D and milestones expense, is $1.74 – $1.78.

Last week, AbbVie began constructing its $70 million expansion at its AbbVie Bioresearch Center in Worcester, Mass., for biologics research, development, and manufacturing. This expansion is part of the company’s previously announced commitment to invest more than $10 billion in the U.S.

Price Action: ABBV stock is down 1.35% at $230.75 at the last check on Monday.

Loading...
Loading...

Read Next:

Photo: Shutterstock

Market News and Data brought to you by Benzinga APIs

Comments
Loading...