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.
ABBV Seeks FDA Nod for Rinvoq Label Expansion in Alopecia Areata
Read MoreHide Full Article
Key Takeaways
AbbVie filed with the FDA to expand Rinvoq use to treat severe alopecia areata in adults and adolescents.
Rinvoq showed strong hair regrowth, meeting key endpoints in phase III UP-AA studies vs placebo.
Long-term data showed sustained efficacy and safety, with no new risks observed in a year.
AbbVie (ABBV - Free Report) announced that it has submitted a regulatory filing to the FDA seeking approval for a new indication of its blockbuster immunology drug, Rinvoq (upadacitinib). The filing seeks approval for the drug to treat adults and adolescents with severe alopecia areata (AA), a chronic immune-mediated condition.
The drug is currently approved to treat a wide range of chronic inflammatory conditions. These include ulcerative colitis (UC), Crohn's disease (CD), rheumatoid arthritis, active psoriatic arthritis (PsA), ankylosing spondylitis, non-radiographic axial spondyloarthritis, giant cell arteritis, atopic dermatitis and active polyarticular juvenile idiopathic arthritis.
Year to date, ABBV shares have declined 13.5% compared with the industry’s 7.5% decline.
Image Source: Zacks Investment Research
FDA Filing for Rinvoq Backed by Pivotal Phase III Program
The application to the FDA is supported by data from the phase III UP-AA clinical program, which evaluated Rinvoq once-daily at 15 mg and 30 mg doses in patients with severe AA. The program included two replicate studies, with period A lasting 24 weeks, followed by period B, a blinded extension that lasted 52 weeks.
The treatment with Rinvoq demonstrated robust and sustained efficacy across the studies. At 24 weeks, both the 15 mg and 30 mg doses of Rinvoq met the primary endpoint of achieving at least 80% scalp hair coverage (SALT ≤20), significantly outperforming placebo. A meaningful proportion of patients also achieved complete scalp coverage (SALT = 0). These responses continued to improve through 52 weeks in the extension phase, highlighting durable benefits over time. The safety profile of Rinvoq remained consistent through one year of treatment, aligning with previously reported findings and no new safety signals were observed.
Alopecia areata is an unpredictable autoimmune disorder that can cause patchy to complete loss of all body hair, leading to stigma and a reduced quality of life.
A similar regulatory filing is also under review by the European Medicines Agency.
Rinvoq: A Key Revenue Generator for ABBV
Rinvoq is a key growth driver for AbbVie. Sales of the drug soared 23.3% year over year to nearly $2.1 billion in the first quarter 2026, accounting for 14% of the company’s total revenues.
Beyond AA, the drug is currently being evaluated in several late-stage studies for hidradenitis suppurativa, takayasu arteritis, systemic lupus erythematosus and vitiligo.
Phase III data for Rinvoq in hidradenitis suppurativa and systemic lupus erythematosus are expected in 2026. AbbVie believes that the next wave of potential approvals in Rinvoq could add roughly $2 billion to peak-year sales for the product.
Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $7.32 to $6.36. Over the same period, loss per share estimates for 2027 have also narrowed from $5.97 to $4.64. AMRN shares have witnessed no change year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 51.29%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.42 to $1.40. Over the same period, loss per share estimates for 2027 have also narrowed from 79 cents to 78 cents. CSTL shares have lost 36.5% year to date.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.59 to $2.87. Over the same period, EPS estimates for 2027 have surged from $3.01 to $3.25. CPRX shares have gained 26.2% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
View the Zacks #1 Rank List
Image: Bigstock
ABBV Seeks FDA Nod for Rinvoq Label Expansion in Alopecia Areata
Key Takeaways
AbbVie (ABBV - Free Report) announced that it has submitted a regulatory filing to the FDA seeking approval for a new indication of its blockbuster immunology drug, Rinvoq (upadacitinib). The filing seeks approval for the drug to treat adults and adolescents with severe alopecia areata (AA), a chronic immune-mediated condition.
The drug is currently approved to treat a wide range of chronic inflammatory conditions. These include ulcerative colitis (UC), Crohn's disease (CD), rheumatoid arthritis, active psoriatic arthritis (PsA), ankylosing spondylitis, non-radiographic axial spondyloarthritis, giant cell arteritis, atopic dermatitis and active polyarticular juvenile idiopathic arthritis.
Year to date, ABBV shares have declined 13.5% compared with the industry’s 7.5% decline.
Image Source: Zacks Investment Research
FDA Filing for Rinvoq Backed by Pivotal Phase III Program
The application to the FDA is supported by data from the phase III UP-AA clinical program, which evaluated Rinvoq once-daily at 15 mg and 30 mg doses in patients with severe AA. The program included two replicate studies, with period A lasting 24 weeks, followed by period B, a blinded extension that lasted 52 weeks.
The treatment with Rinvoq demonstrated robust and sustained efficacy across the studies. At 24 weeks, both the 15 mg and 30 mg doses of Rinvoq met the primary endpoint of achieving at least 80% scalp hair coverage (SALT ≤20), significantly outperforming placebo. A meaningful proportion of patients also achieved complete scalp coverage (SALT = 0). These responses continued to improve through 52 weeks in the extension phase, highlighting durable benefits over time. The safety profile of Rinvoq remained consistent through one year of treatment, aligning with previously reported findings and no new safety signals were observed.
Alopecia areata is an unpredictable autoimmune disorder that can cause patchy to complete loss of all body hair, leading to stigma and a reduced quality of life.
A similar regulatory filing is also under review by the European Medicines Agency.
Rinvoq: A Key Revenue Generator for ABBV
Rinvoq is a key growth driver for AbbVie. Sales of the drug soared 23.3% year over year to nearly $2.1 billion in the first quarter 2026, accounting for 14% of the company’s total revenues.
Beyond AA, the drug is currently being evaluated in several late-stage studies for hidradenitis suppurativa, takayasu arteritis, systemic lupus erythematosus and vitiligo.
Phase III data for Rinvoq in hidradenitis suppurativa and systemic lupus erythematosus are expected in 2026. AbbVie believes that the next wave of potential approvals in Rinvoq could add roughly $2 billion to peak-year sales for the product.
ABBV’s Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amarin Corporation (AMRN - Free Report) and Castle Biosciences (CSTL - Free Report) ), each currently sporting a Zacks Rank #1 (Strong Buy), and Catalyst Pharmaceuticals (CPRX - Free Report) , which 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, estimates for Amarin’s 2026 loss per share have narrowed from $7.32 to $6.36. Over the same period, loss per share estimates for 2027 have also narrowed from $5.97 to $4.64. AMRN shares have witnessed no change year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 51.29%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.42 to $1.40. Over the same period, loss per share estimates for 2027 have also narrowed from 79 cents to 78 cents. CSTL shares have lost 36.5% year to date.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.59 to $2.87. Over the same period, EPS estimates for 2027 have surged from $3.01 to $3.25. CPRX shares have gained 26.2% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.