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AbbVie (ABBV) Files for Rinvoq in Giant Cell Arteritis in US & EU
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AbbVie Inc. (ABBV - Free Report) announced that it has submitted regulatory applications to the FDA and the European Medicines Agency (EMA), seeking approval for its JAK inhibitor, Rinvoq (upadacitinib), for a new indication.
The company is seeking approval for once-daily Rinvoq (15 mg) for treating adult patients with giant cell arteritis (GCA), an autoimmune disease-causing inflammation of the large arteries.
The regulatory filings for GCA were based on data from the phase III SELECT-GCA study, which evaluated the safety and efficacy of Rinvoq in GCA patients.
Data from the SELECT-GCA study showed that 46% of the GCA patients treated with Rinvoq plus 26-week steroid taper regimen achieved the primary endpoint of sustained remission (absence of GCA signs and symptoms) from week 12 through week 52 versus 29% of patients administered placebo with a 52-week steroid taper regimen. The study also met its key secondary endpoints, with 37% of patients in the Rinvoq arm achieving sustained complete remission compared to 16% of patients in the placebo arm.
Shares of AbbVie have gained 9.9% so far this year compared with the industry’s growth of 24.2%.
Image Source: Zacks Investment Research
Rinvoq, a JAK inhibitor, was initially approved in 2019 to treat moderate-to-severe rheumatoid arthritis (RA). Apart from RA, the drug is also approved for psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, axial spondyloarthropathy, Crohn’s disease and ulcerative colitis.
Last month, ABBV launched Rinvoq, as a tablet and oral solution, in the United States for pediatric patients, two years and older, with polyarticular juvenile idiopathic arthritis and psoriatic arthritis who had an inadequate response or intolerance to one or more tumor necrosis factor blockers. These are the first pediatric indications for Rinvoq, which is now approved for eight indications across immune-mediated inflammatory diseases.
Label-expanding studies evaluating Rinvoq in several immune-mediated diseases, including GCA, systemic lupus erythematosus, hidradenitis suppurativa vitiligo and takayasu arteritis, are ongoing.
Rinvoq is a key top-line driver for AbbVie. The drug generated sales of $1.09 billion in the first quarter of 2024, which was up 61.9% year over year, owing to continuous label expansions of the drug to include new patient populations.
Rinvoq and AbbVie’s other inflammatory disease drug, Skyrizi, are performing extremely well, bolstered by approvals in new indications. The drugs have the potential to replace revenues lost from blockbuster drug Humira, which started facing generic erosion in the United States in early 2023. Skyrizi and Rinvoq are expected to collectively exceed the peak revenues achieved by Humira by 2027. AbbVie expects the combined sales (risk-adjusted) of Skyrizi and Rinvoq to be more than $27 billion by 2027.
In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.05 to $2.47. Loss per share estimates for 2025 have narrowed from $3.04 to $2.55. Year to date, ACRV’s shares have rallied 51.4%.
ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 3.56%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Year to date, ADPT’s shares have declined 18.3%.
ADPT’s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, RAPT’s shares have declined 86%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.
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AbbVie (ABBV) Files for Rinvoq in Giant Cell Arteritis in US & EU
AbbVie Inc. (ABBV - Free Report) announced that it has submitted regulatory applications to the FDA and the European Medicines Agency (EMA), seeking approval for its JAK inhibitor, Rinvoq (upadacitinib), for a new indication.
The company is seeking approval for once-daily Rinvoq (15 mg) for treating adult patients with giant cell arteritis (GCA), an autoimmune disease-causing inflammation of the large arteries.
The regulatory filings for GCA were based on data from the phase III SELECT-GCA study, which evaluated the safety and efficacy of Rinvoq in GCA patients.
Data from the SELECT-GCA study showed that 46% of the GCA patients treated with Rinvoq plus 26-week steroid taper regimen achieved the primary endpoint of sustained remission (absence of GCA signs and symptoms) from week 12 through week 52 versus 29% of patients administered placebo with a 52-week steroid taper regimen. The study also met its key secondary endpoints, with 37% of patients in the Rinvoq arm achieving sustained complete remission compared to 16% of patients in the placebo arm.
Shares of AbbVie have gained 9.9% so far this year compared with the industry’s growth of 24.2%.
Image Source: Zacks Investment Research
Rinvoq, a JAK inhibitor, was initially approved in 2019 to treat moderate-to-severe rheumatoid arthritis (RA). Apart from RA, the drug is also approved for psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, axial spondyloarthropathy, Crohn’s disease and ulcerative colitis.
Last month, ABBV launched Rinvoq, as a tablet and oral solution, in the United States for pediatric patients, two years and older, with polyarticular juvenile idiopathic arthritis and psoriatic arthritis who had an inadequate response or intolerance to one or more tumor necrosis factor blockers. These are the first pediatric indications for Rinvoq, which is now approved for eight indications across immune-mediated inflammatory diseases.
Label-expanding studies evaluating Rinvoq in several immune-mediated diseases, including GCA, systemic lupus erythematosus, hidradenitis suppurativa vitiligo and takayasu arteritis, are ongoing.
Rinvoq is a key top-line driver for AbbVie. The drug generated sales of $1.09 billion in the first quarter of 2024, which was up 61.9% year over year, owing to continuous label expansions of the drug to include new patient populations.
Rinvoq and AbbVie’s other inflammatory disease drug, Skyrizi, are performing extremely well, bolstered by approvals in new indications. The drugs have the potential to replace revenues lost from blockbuster drug Humira, which started facing generic erosion in the United States in early 2023. Skyrizi and Rinvoq are expected to collectively exceed the peak revenues achieved by Humira by 2027. AbbVie expects the combined sales (risk-adjusted) of Skyrizi and Rinvoq to be more than $27 billion by 2027.
Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Acrivon Therapeutics, Inc. (ACRV - Free Report) , Adaptive Biotechnologies Corporation (ADPT - Free Report) and RAPT Therapeutics, Inc. (RAPT - Free Report) , each holding a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.05 to $2.47. Loss per share estimates for 2025 have narrowed from $3.04 to $2.55. Year to date, ACRV’s shares have rallied 51.4%.
ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 3.56%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Year to date, ADPT’s shares have declined 18.3%.
ADPT’s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, RAPT’s shares have declined 86%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.