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ABBV's Newly Added Parkinson's Disease Drug Meets Second Study Goal
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AbbVie (ABBV - Free Report) announced positive top-line results from the pivotal phase III TEMPO-1 study which evaluated its recently acquired investigational drug tavapadon in adults with early Parkinson’s disease (PD).
The study achieved its primary endpoint, patients who received two fixed doses (5mg and 15mg) of once-daily tavapadon for 26 weeks achieved statistically significant improvement in disease burden. This was measured using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score, a scale developed to evaluate various aspects of PD.
Treatment with the drug also met the key secondary endpoint of statistically significant and clinically meaningful improvement in motor aspects of patients in their daily living across both dose groups for a 26-week treatment period. The safety profile of the drug was also consistent with previously reported clinical studies.
AbbVie intends to use the data from this study when it seeks regulatory approval for tavapadon in PD indication. Management plans to present detailed results from this study at a future medical meeting.
ABBV Stock Performance
Year to date, AbbVie’s shares have moved up 23.8% compared with the industry’s 21.6% rise.
Image Source: Zacks Investment Research
Recent Developments Related to ABBV’s Tavapadon
The TEMPO-1 study is one of the four clinical studies in the late-stage TEMPO clinical development program, which is evaluating tavapadon across a broad PD population.
Earlier this year, AbbVie reported data from the late-stage TEMPO-3 study that evaluated the drug as an adjunctive therapy to levodopa in adult patients with PD. The study met its primary endpoint, the drug, when used as an add-on to levodopa, improved symptom control. Levodopa is the current standard of care for PD symptoms.
The company also plans to report data from the phase III TEMPO-3 study, which is evaluating flexible doses of the drug in early PD patients, by this year’s end. The fourth study, named TEMPO-4, is an open-label extension study to assess the long-term safety and tolerability of the drug in PD patients.
A 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. The completion of this acquisition was announced last month. Through this transaction, management intends to strengthen its neuroscience pipeline by adding Cerevel’s novel pipeline candidates being studied across a range of psychiatric and neurological disorders, which also include schizophrenia and mood disorders.
Apart from tavapadon, the Cerevel acquisition also added some other promising neuroscience pipeline candidates to AbbVie’s pipeline, like emraclidine (in phase II studies for schizophrenia) and darigabat (in phase II studies for epilepsy and panic disorder).
In the past 60 days, estimates for Bioventus’ 2024 earnings per share (EPS) have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 109.7%.
BVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have risen from $2.09 to $2.38. Estimates for 2025 have increased from $4.33 to $7.31 during the same period. Year to date, Krystal Biotech’s shares have surged 43.8%.
Earnings of Krystal Biotech beat estimates in three of the last four quarters and missed the mark on one occasion. Krystal Biotech delivered a four-quarter average earnings surprise of 45.95%.
In the past 60 days, estimates for ADMA Biologics’ 2024 EPS have risen from 35 cents to 49 cents. EPS Estimates for 2025 have increased from 53 cents to 64 cents during the same period. Year to date, shares of ADMA Biologics have skyrocketed 330.1%.
ADMA’s earnings beat estimates in each of the last four quarters. ADMA Biologics delivered a four-quarter average earnings surprise of 105.63%.
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ABBV's Newly Added Parkinson's Disease Drug Meets Second Study Goal
AbbVie (ABBV - Free Report) announced positive top-line results from the pivotal phase III TEMPO-1 study which evaluated its recently acquired investigational drug tavapadon in adults with early Parkinson’s disease (PD).
The study achieved its primary endpoint, patients who received two fixed doses (5mg and 15mg) of once-daily tavapadon for 26 weeks achieved statistically significant improvement in disease burden. This was measured using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score, a scale developed to evaluate various aspects of PD.
Treatment with the drug also met the key secondary endpoint of statistically significant and clinically meaningful improvement in motor aspects of patients in their daily living across both dose groups for a 26-week treatment period. The safety profile of the drug was also consistent with previously reported clinical studies.
AbbVie intends to use the data from this study when it seeks regulatory approval for tavapadon in PD indication. Management plans to present detailed results from this study at a future medical meeting.
ABBV Stock Performance
Year to date, AbbVie’s shares have moved up 23.8% compared with the industry’s 21.6% rise.
Image Source: Zacks Investment Research
Recent Developments Related to ABBV’s Tavapadon
The TEMPO-1 study is one of the four clinical studies in the late-stage TEMPO clinical development program, which is evaluating tavapadon across a broad PD population.
Earlier this year, AbbVie reported data from the late-stage TEMPO-3 study that evaluated the drug as an adjunctive therapy to levodopa in adult patients with PD. The study met its primary endpoint, the drug, when used as an add-on to levodopa, improved symptom control. Levodopa is the current standard of care for PD symptoms.
The company also plans to report data from the phase III TEMPO-3 study, which is evaluating flexible doses of the drug in early PD patients, by this year’s end. The fourth study, named TEMPO-4, is an open-label extension study to assess the long-term safety and tolerability of the drug in PD patients.
A 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. The completion of this acquisition was announced last month. Through this transaction, management intends to strengthen its neuroscience pipeline by adding Cerevel’s novel pipeline candidates being studied across a range of psychiatric and neurological disorders, which also include schizophrenia and mood disorders.
Apart from tavapadon, the Cerevel acquisition also added some other promising neuroscience pipeline candidates to AbbVie’s pipeline, like emraclidine (in phase II studies for schizophrenia) and darigabat (in phase II studies for epilepsy and panic disorder).
ABBV’s Zacks Rank
AbbVie currently carries a Zacks Rank #3 (Hold).
AbbVie Inc. Price
AbbVie Inc. price | AbbVie Inc. Quote
Our Key Picks Among Biotech Stocks
Some better-ranked stocks include Bioventus (BVS - Free Report) , Krystal Biotech (KRYS - Free Report) and ADMA Biologics (ADMA - Free Report) . While BVS and KRYS each sport a Zacks Rank #1 (Strong Buy), ADMA carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share (EPS) have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 109.7%.
BVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have risen from $2.09 to $2.38. Estimates for 2025 have increased from $4.33 to $7.31 during the same period. Year to date, Krystal Biotech’s shares have surged 43.8%.
Earnings of Krystal Biotech beat estimates in three of the last four quarters and missed the mark on one occasion. Krystal Biotech delivered a four-quarter average earnings surprise of 45.95%.
In the past 60 days, estimates for ADMA Biologics’ 2024 EPS have risen from 35 cents to 49 cents. EPS Estimates for 2025 have increased from 53 cents to 64 cents during the same period. Year to date, shares of ADMA Biologics have skyrocketed 330.1%.
ADMA’s earnings beat estimates in each of the last four quarters. ADMA Biologics delivered a four-quarter average earnings surprise of 105.63%.