AbbVie ABBV 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.
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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 and Castle Biosciences (CSTL), each currently sporting a Zacks Rank #1 (Strong Buy), and Catalyst Pharmaceuticals CPRX, 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%.
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AbbVie Inc. (ABBV): Free Stock Analysis Report
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This article originally published on Zacks Investment Research (zacks.com).