We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
AbbVie's Rinvoq Wins EU Approval in Juvenile Idiopathic Arthritis
Read MoreHide Full Article
Key Takeaways
ABBV's Rinvoq gains EU approval for pJIA in patients aged two years and older with inadequate DMARD. response.
Rinvoq's pJIA approval was supported by SELECT-YOUTH data showing gains in disease activity by week 12.
By week 48, Rinvoq's ACR Pediatric 70 response reached 79.5%, while clinical remission rose to 43.4%.
AbbVie (ABBV - Free Report) announced that the European Commission ("EC") has approved its blockbuster immunology drug, Rinvoq (upadacitinib), for a new indication. The drug is approved in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients aged two years and older who have had an inadequate response or intolerance to disease-modifying antirheumatic drugs (DMARDs).
The approval marks the 11th indication for Rinvoq in the European Union, further expanding the drug’s use across chronic inflammatory diseases. For pJIA, Rinvoq can be used either as monotherapy or in combination with methotrexate.
Rinvoq is already approved in the United States for the treatment of pJIA. In the European Union, the drug is approved across several other chronic inflammatory conditions, including ulcerative colitis, Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, giant cell arteritis and atopic dermatitis.
In July, the EC approved Rinvoq for alopecia areata and vitiligo. Regulatory applications for both indications are currently under review in the United States.
Juvenile idiopathic arthritis is the most common rheumatic disease in children, affecting an estimated 126,000 children in Europe. pJIA is a subtype that causes inflammation in joints, including the hands, feet, knees, hips and ankles, lasting for at least six weeks.
Year to date, ABBV's shares have rallied 18.5% compared with the industry’s 14.2% growth.
Image Source: Zacks Investment Research
Rinvoq’s EC Approval for pJIA Validates ABBV’s Clinical Data
The EC approval for pJIA was supported by results from the open-label phase I SELECT-YOUTH study, along with data from adult patients with rheumatoid arthritis. The study showed meaningful improvements in disease activity as early as week 12, with responses continuing to improve through week 48. At week 12, 66.4% of patients achieved an ACR Pediatric 70 response, which increased to 79.5% by week 48.
The proportion of patients achieving clinical remission increased from 23% at week 12 to 43.4% at week 48. Patients additionally reported improvements in physical functioning and pain, supporting the potential benefits of Rinvoq in children with pJIA.
The treatment response in children with pJIA was generally similar to that seen in adults with rheumatoid arthritis.
Rinvoq: A Key Growth Driver for ABBV
Rinvoq is a key growth driver for AbbVie. Sales of the drug soared 22.2% year over year to $4.64 billion in the first half of 2026, driven by strong demand for all approved indications. In 2026, AbbVie expects Rinvoq revenues to be around $10.2 billion.
The drug is being evaluated in late-stage studies for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus. It is also being studied in children with systemic juvenile idiopathic arthritis, atopic dermatitis, ulcerative colitis and Crohn’s disease. Phase III data for Rinvoq in hidradenitis suppurativa and systemic lupus erythematosus are expected in 2026.
ABBV, Iambic Join Hands to Advance AI-Driven Drug Discovery
In a separate press release, the company announced a multi-year collaboration with Iambic to accelerate the discovery and development of small-molecule therapies. The partnership will focus on potential first-in-class and best-in-class treatments in immunology, neuroscience and oncology.
Per the deal, AbbVie will use Iambic’s AI-powered drug discovery platform, including its next-generation Enchant v3 model, to improve the design and selection of promising drug candidates. Iambic will receive an upfront payment and is eligible for milestone payments and tiered royalties on net sales of products developed through the collaboration.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents per share. PGEN's shares have gained 84.2% year to date.
Precigen’s earnings beat estimates 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, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU's shares have lost 15.5% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX's shares have plunged 74% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
View the Zacks #1 Rank List
Image: Bigstock
AbbVie's Rinvoq Wins EU Approval in Juvenile Idiopathic Arthritis
Key Takeaways
AbbVie (ABBV - Free Report) announced that the European Commission ("EC") has approved its blockbuster immunology drug, Rinvoq (upadacitinib), for a new indication. The drug is approved in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients aged two years and older who have had an inadequate response or intolerance to disease-modifying antirheumatic drugs (DMARDs).
The approval marks the 11th indication for Rinvoq in the European Union, further expanding the drug’s use across chronic inflammatory diseases. For pJIA, Rinvoq can be used either as monotherapy or in combination with methotrexate.
Rinvoq is already approved in the United States for the treatment of pJIA. In the European Union, the drug is approved across several other chronic inflammatory conditions, including ulcerative colitis, Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, giant cell arteritis and atopic dermatitis.
In July, the EC approved Rinvoq for alopecia areata and vitiligo. Regulatory applications for both indications are currently under review in the United States.
Juvenile idiopathic arthritis is the most common rheumatic disease in children, affecting an estimated 126,000 children in Europe. pJIA is a subtype that causes inflammation in joints, including the hands, feet, knees, hips and ankles, lasting for at least six weeks.
Year to date, ABBV's shares have rallied 18.5% compared with the industry’s 14.2% growth.
Image Source: Zacks Investment Research
Rinvoq’s EC Approval for pJIA Validates ABBV’s Clinical Data
The EC approval for pJIA was supported by results from the open-label phase I SELECT-YOUTH study, along with data from adult patients with rheumatoid arthritis. The study showed meaningful improvements in disease activity as early as week 12, with responses continuing to improve through week 48. At week 12, 66.4% of patients achieved an ACR Pediatric 70 response, which increased to 79.5% by week 48.
The proportion of patients achieving clinical remission increased from 23% at week 12 to 43.4% at week 48. Patients additionally reported improvements in physical functioning and pain, supporting the potential benefits of Rinvoq in children with pJIA.
The treatment response in children with pJIA was generally similar to that seen in adults with rheumatoid arthritis.
Rinvoq: A Key Growth Driver for ABBV
Rinvoq is a key growth driver for AbbVie. Sales of the drug soared 22.2% year over year to $4.64 billion in the first half of 2026, driven by strong demand for all approved indications. In 2026, AbbVie expects Rinvoq revenues to be around $10.2 billion.
The drug is being evaluated in late-stage studies for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus. It is also being studied in children with systemic juvenile idiopathic arthritis, atopic dermatitis, ulcerative colitis and Crohn’s disease. Phase III data for Rinvoq in hidradenitis suppurativa and systemic lupus erythematosus are expected in 2026.
ABBV, Iambic Join Hands to Advance AI-Driven Drug Discovery
In a separate press release, the company announced a multi-year collaboration with Iambic to accelerate the discovery and development of small-molecule therapies. The partnership will focus on potential first-in-class and best-in-class treatments in immunology, neuroscience and oncology.
Per the deal, AbbVie will use Iambic’s AI-powered drug discovery platform, including its next-generation Enchant v3 model, to improve the design and selection of promising drug candidates. Iambic will receive an upfront payment and is eligible for milestone payments and tiered royalties on net sales of products developed through the collaboration.
ABBV’s Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents per share. PGEN's shares have gained 84.2% year to date.
Precigen’s earnings beat estimates 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, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU's shares have lost 15.5% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX's shares have plunged 74% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.