AbbVie Seeks FDA Approval for Subcutaneous Skyrizi
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 27 2026
0mins
Should l Buy ABBV?
Source: seekingalpha
- FDA Application Filed: AbbVie has submitted an application to the US FDA for approval of a subcutaneous formulation of Skyrizi (risankizumab), aiming to provide a more convenient administration method that is expected to enhance patient adherence.
- Clinical Trial Support: The application is backed by data from the phase 3 AFFIRM trial, which enrolled patients with moderately to severely active Crohn's disease, demonstrating significant clinical efficacy.
- Efficacy Metrics Achieved: At week 12, Skyrizi surpassed placebo on both co-primary endpoints, Crohn's Disease Activity Index (CDAI) clinical remission and endoscopic response, indicating its substantial therapeutic effect.
- Expected Approval Timeline: AbbVie anticipates receiving approval for subcutaneous Skyrizi by the end of the year, which will further bolster the company's competitive position in the Crohn's disease treatment market.
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Analyst Views on ABBV
Wall Street analysts forecast ABBV stock price to rise
18 Analyst Rating
12 Buy
6 Hold
0 Sell
Moderate Buy
Current: 208.160
Low
223.00
Averages
252.00
High
289.00
Current: 208.160
Low
223.00
Averages
252.00
High
289.00
About ABBV
AbbVie Inc. is a global, diversified research-based biopharmaceutical company. It is engaged in research and development, manufacturing, commercialization and sale of medicines and therapies. Its product portfolio includes Immunology, Oncology, Aesthetics, Neuroscience, Eye Care and Other Key Products. Immunology products include rheumatology, dermatology and gastroenterology. Oncology products include Imbruvica, Venclexta/Venclyxto, Elahere and Epkinly. Aesthetics portfolio consists of facial injectables, plastics and regenerative medicine, body contouring, and skincare products. Its Neuroscience products include Botox Therapeutic, Vraylar, Duopa and Duodopa, Ubrelvy, and Qulipta. Eye Care products include Ozurdex, Lumigan/Ganfort, Alphagan/Combigan, Restasis, and other eye care. Other key products include Mavyret/Maviret, Creon, and Linzess/Constella. Its investigational candidate, bretisilocin, is for the treatment of patients with moderate-to-severe major depressive disorder (MDD).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
AbbVie Surprises with Strong Q1 Earnings, Boosting Stock
- Significant Revenue Growth: AbbVie's Q1 revenue reached $15 billion, marking a 12.4% year-over-year increase and surpassing the expected $14.7 billion, showcasing the company's strong performance in immunology and boosting investor confidence.
- Strong Immunology Business: Sales of Skyrizi and Rinvoq exceeded management's expectations, with AbbVie now projecting combined revenues of over $31 billion for these drugs in 2023, four years ahead of the previous 2027 target, reflecting the company's competitive edge in the market.
- Potential Expansion Opportunities: Rinvoq is awaiting approval for alopecia areata treatment, while Skyrizi could gain a new indication for Crohn's disease, which will further drive sales growth and enhance AbbVie's market position.
- Long-Term Growth Outlook: AbbVie has raised its earnings per share guidance for 2026, and with its strong product lineup and robust dividend policy, the company remains an attractive investment despite a 10% decline in stock price year-to-date.
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- Clinical Data Support: The studies indicate a low switch rate for SKYRIZI among Crohn's disease patients and a significant reduction in hospitalization rates after switching to RINVOQ, providing critical evidence for treatment decisions.
- Quality of Life Improvement: SKYRIZI has demonstrated improvements in health-related quality of life for Crohn's disease patients, with year-one results from the ASPIRE-CD study showing significant symptom relief, indicating its clinical application potential.
- FDA Application Progress: On April 27, 2026, AbbVie submitted an application to the FDA seeking approval for SKYRIZI's subcutaneous induction treatment in adult patients with Crohn's disease, which, if approved, will further expand its market share.
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- Significant Revenue Growth: AbbVie's Q1 revenue reached $15 billion, marking a 12.4% year-over-year increase and surpassing the expected $14.7 billion, showcasing the company's strong performance in immunology and boosting investor confidence.
- Strong Immunology Business: Sales of Skyrizi and Rinvoq exceeded management's expectations, with AbbVie now projecting combined revenues of over $31 billion for these drugs in 2023, four years ahead of the previous 2027 target, reflecting the company's competitive edge in the market.
- Potential Expansion Opportunities: Rinvoq is awaiting approval for alopecia areata treatment, while Skyrizi could gain a new indication for Crohn's disease, which will further drive sales growth and enhance AbbVie's market position.
- Long-Term Growth Outlook: AbbVie has raised its earnings per share guidance for 2026, and with its strong product lineup and robust dividend policy, the company remains an attractive investment despite a 10% decline in stock price year-to-date.
See More
AbbVie Presents New Data at Digestive Disease Week 2026
- Research Presentation: AbbVie showcased 18 abstracts at the 2026 Digestive Disease Week, highlighting long-term efficacy data for SKYRIZI and RINVOQ in Crohn's disease and ulcerative colitis, reinforcing its leadership in gastroenterology.
- Clinical Data Support: The studies indicate a low switch rate for SKYRIZI among Crohn's disease patients and a significant reduction in hospitalization rates after switching to RINVOQ, providing critical evidence for treatment decisions.
- Quality of Life Improvement: SKYRIZI has demonstrated improvements in health-related quality of life for Crohn's disease patients, with year-one results from the ASPIRE-CD study showing significant symptom relief, indicating its clinical application potential.
- FDA Application Progress: On April 27, 2026, AbbVie submitted an application to the FDA seeking approval for SKYRIZI's subcutaneous induction treatment in adult patients with Crohn's disease, which, if approved, will further expand its market share.
See More
Three Dividend Stocks Worth Investing In
- AbbVie's Growth Potential: AbbVie successfully expanded its product portfolio and added Botox through a $63 billion acquisition of Allergan, and despite losing patent protection for its flagship drug Humira, the company still achieved over 12% revenue growth in Q1 2026, demonstrating strong growth potential.
- Verizon's Acquisition Advantage: With a dividend yield of 5.9%, Verizon attracts investors, and despite a 17% stock price increase this year, its forward P/E ratio is only 10; the acquisition of Frontier is expected to enhance its fiber access capabilities, further boosting future growth prospects.
- Canadian Natural Resources' Inflation Hedge: Canadian Natural Resources has seen its stock price rise 40% this year amid rising oil prices, and while its dividend yield stands at 3.8%, its forward P/E remains below 14, indicating strong profitability even in economic uncertainty.
- Sustained Dividend Growth: Canadian Natural Resources has raised its dividend for 26 consecutive years, averaging a compounded annual growth rate of about 20%, maintaining stable dividend payments even during periods of low oil prices, showcasing its appeal as a high-dividend stock.
See More
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- AbbVie's Growth Potential: AbbVie expanded its product portfolio and added Botox through a $63 billion acquisition of Allergan in 2020, successfully growing its revenue by over 12% in Q1 2026 despite losing patent protection on its top drug, Humira.
- Verizon's Acquisition Advantage: With a 5.9% dividend yield, Verizon remains attractive to investors; despite a 17% stock price increase this year, its forward P/E is just 10, and the acquisition of Frontier will enhance its fiber access and future growth prospects.
- Canadian Natural Resources' Inflation Hedge: Canadian Natural Resources stock has surged 40% due to rising oil prices, and while this affects its 3.8% dividend yield, it has consistently raised dividends for 26 years, demonstrating stability amid economic uncertainty.
- Investment Value of Dividend Stocks: These high-dividend stocks not only provide stable income but also reduce overall portfolio risk, making AbbVie, Verizon, and Canadian Natural Resources noteworthy investment options right now.
See More
Analysis of the Best Stocks to Invest in Now
- Amazon's Sustained Growth: Amazon (AMZN) reported a 17% year-over-year increase in net sales for Q1 2026, reaching $181.5 billion, with expectations of 16% to 19% growth in Q2, indicating strong market demand and business resilience.
- Cloud Services Driving Profitability: Amazon Web Services (AWS) contributed 59% of total operating income in Q1, with revenue soaring 28% year-over-year to $37.6 billion, underscoring the company's continued leadership and profitability in the cloud computing sector.
- AbbVie's Stability: AbbVie (ABBV), a member of the Dividend Kings, has increased its dividend for 50 consecutive years, currently offering a 3.3% yield, highlighting its long-term stability and appeal amid rising market uncertainties.
- Viking's Market Leadership: Viking Holdings (VIK) commands a 52% market share in North American outbound river cruises, with 86% of its 2026 capacity sold out, reflecting strong demand and financial visibility in the luxury cruise market.
See More
Biotech Dealmaking Accelerates Ahead of Patent Cliffs
- Surge in M&A Activity: Biotech M&A deal value reached $84 billion in Q1 2026, a staggering 89.4% increase from $44.4 billion a year earlier, indicating a robust market recovery, with projections suggesting total annual deal value could exceed $250 billion, ranking second only to 2019.
- Patent Cliffs Catalyst: Pharmaceutical companies are accelerating M&A due to impending patent cliffs, with over $300 billion in revenue facing loss of exclusivity in the next five years, particularly with Merck's Keytruda losing exclusivity in 2028, adding to market uncertainty.
- Strong Cash Reserves Fuel Acquisitions: Eli Lilly, for instance, ended 2025 with over $7.27 billion in cash and equivalents, having spent over $35 billion on acquisitions in 2023, demonstrating that strong financial positions make M&A decisions more justifiable at the board level.
- Mid-Sized Deals Dominate: Recent CEO transitions at GSK and Novo Nordisk have led to more aggressive M&A strategies, with analysts noting that the global revenue exposed to patent expirations over the next seven years is 2.5 times higher than in the last 16 years, further driving the activity in mid-sized deals.
See More
