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AbbVie Wins FDA Nod for New Parkinson's Disease Drug Juvmo
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Key Takeaways
AbbVie's Juvmo wins FDA approval as a once-daily oral treatment for Parkinson's disease.
Juvmo can be used alone or with levodopa to improve motor symptoms and daily functioning.
AbbVie expects Juvmo, Vyalev and Duopa to represent a Parkinson's opportunity exceeding $5 billion.
AbbVie (ABBV - Free Report) announced that the FDA has approved tavapadon as a once-daily oral treatment for Parkinson’s disease (PD). The drug, which will be marketed under the brand name Juvmo, will be commercially launched next month.
Per the company, this approval marks the first ‘dopaminergic breakthrough’ for PD in decades. Juvmo can be used alone or in combination with levodopa, the current standard of care for PD symptoms. This may be particularly relevant as PD progresses, as patients often require increasing doses of levodopa to maintain symptom control, which can be accompanied by motor complications. By providing an additional mechanism for controlling motor symptoms, Juvmo may help reduce reliance on escalating doses of levodopa.
The FDA approval 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 the TEMPO-1 and TEMPO-2 studies showed that tavapadon significantly improved daily functioning and motor symptoms in early PD patients, the TEMPO-3 results highlighted benefits when the drug was used as an add-on to levodopa.
Juvmo is the first selective D1/D5 dopamine receptor agonist approved for PD. AbbVie gained the drug through its acquisition of Cerevel Therapeutics for approximately $8.7 billion, which was completed in 2024.
ABBV’s Stock Performance
Year to date, the company’s shares have risen about 17% compared with the industry‘s 13% growth.
Image Source: Zacks Investment Research
Juvmo Nod Boosts AbbVie’s PD Franchise
With the latest approval, the company successfully expands its PD portfolio, which previously included Vyalev and Duopa. Management expects the three therapies to collectively represent a PD opportunity of more than $5 billion in peak sales.
Juvmo’s approval represents AbbVie’s second FDA clearance in the PD space in two years, further strengthening its presence in the market. In October 2024, the FDA approved Vyalev as the first 24-hour continuous subcutaneous infusion of carbidopa and levodopa prodrugs for the treatment of motor fluctuations in patients with advanced PD.
PD represents the newest pillar of AbbVie’s neuroscience franchise, with Vyalev emerging as a significant growth driver. The therapy generated $457 million in first-half 2026 sales, up sharply from the prior-year period, while second-quarter sales increased more than 27% sequentially. AbbVie said Vyalev is on track to achieve blockbuster sales this year.
The approval also provides a potential commercial payoff from AbbVie’s Cerevel acquisition, which came under scrutiny after emraclidine failed in two registration-enabling phase II studies for schizophrenia. The setback was particularly significant because emraclidine was one of the key assets underpinning the acquisition and led AbbVie to record a $3.5 billion impairment charge.
Over the past 60 days, estimate for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimate for 2027 have risen from 25 cents to 73 cents. PGEN shares have gained 87% year to date.
Precigen’s earnings beat the Zacks Consensus Estimate in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimate for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimate for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 17% year-to-date.
AC Immune’s earnings beat Zacks Consensus Estimate in each of the trailing four quarters, with the average surprise being 33.25%.
View the Zacks #1 Rank List
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AbbVie Wins FDA Nod for New Parkinson's Disease Drug Juvmo
Key Takeaways
AbbVie (ABBV - Free Report) announced that the FDA has approved tavapadon as a once-daily oral treatment for Parkinson’s disease (PD). The drug, which will be marketed under the brand name Juvmo, will be commercially launched next month.
Per the company, this approval marks the first ‘dopaminergic breakthrough’ for PD in decades. Juvmo can be used alone or in combination with levodopa, the current standard of care for PD symptoms. This may be particularly relevant as PD progresses, as patients often require increasing doses of levodopa to maintain symptom control, which can be accompanied by motor complications. By providing an additional mechanism for controlling motor symptoms, Juvmo may help reduce reliance on escalating doses of levodopa.
The FDA approval 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 the TEMPO-1 and TEMPO-2 studies showed that tavapadon significantly improved daily functioning and motor symptoms in early PD patients, the TEMPO-3 results highlighted benefits when the drug was used as an add-on to levodopa.
Juvmo is the first selective D1/D5 dopamine receptor agonist approved for PD. AbbVie gained the drug through its acquisition of Cerevel Therapeutics for approximately $8.7 billion, which was completed in 2024.
ABBV’s Stock Performance
Year to date, the company’s shares have risen about 17% compared with the industry‘s 13% growth.
Image Source: Zacks Investment Research
Juvmo Nod Boosts AbbVie’s PD Franchise
With the latest approval, the company successfully expands its PD portfolio, which previously included Vyalev and Duopa. Management expects the three therapies to collectively represent a PD opportunity of more than $5 billion in peak sales.
Juvmo’s approval represents AbbVie’s second FDA clearance in the PD space in two years, further strengthening its presence in the market. In October 2024, the FDA approved Vyalev as the first 24-hour continuous subcutaneous infusion of carbidopa and levodopa prodrugs for the treatment of motor fluctuations in patients with advanced PD.
PD represents the newest pillar of AbbVie’s neuroscience franchise, with Vyalev emerging as a significant growth driver. The therapy generated $457 million in first-half 2026 sales, up sharply from the prior-year period, while second-quarter sales increased more than 27% sequentially. AbbVie said Vyalev is on track to achieve blockbuster sales this year.
The approval also provides a potential commercial payoff from AbbVie’s Cerevel acquisition, which came under scrutiny after emraclidine failed in two registration-enabling phase II studies for schizophrenia. The setback was particularly significant because emraclidine was one of the key assets underpinning the acquisition and led AbbVie to record 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
Our Key Picks Among Biotech Stocks
Some better-ranked stocks in the sector include Precigen (PGEN - Free Report) and AC Immune (ACIU - Free Report) . While PGEN sports a Zacks Rank #1 (Strong Buy) at present, ACIU carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimate for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimate for 2027 have risen from 25 cents to 73 cents. PGEN shares have gained 87% year to date.
Precigen’s earnings beat the Zacks Consensus Estimate in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimate for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimate for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 17% year-to-date.
AC Immune’s earnings beat Zacks Consensus Estimate in each of the trailing four quarters, with the average surprise being 33.25%.