AbbVie Seeks FDA Approval for SKYRIZI in Crohn's Disease Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy ABBV?
Source: Newsfilter
- FDA Application Submitted: AbbVie has submitted an application to the U.S. FDA for SKYRIZI (risankizumab-rzaa) for subcutaneous administration in adult patients with moderately to severely active Crohn's disease, which, if approved, will provide a new treatment option for approximately 1 million Americans, enhancing the company's market position in immunotherapy.
- Clinical Trial Support: The application is backed by positive data from the Phase 3 AFFIRM study, which demonstrated the efficacy and safety of risankizumab SC in moderately to severely active Crohn's disease patients, involving 289 participants, with 65% having previously failed advanced therapies, indicating significant market demand for the drug.
- Diverse Treatment Options: If approved by the FDA, patients will have the choice to receive SKYRIZI induction treatment via subcutaneous injection or intravenous infusion, followed by subcutaneous maintenance dosing every eight weeks, which will help improve patient adherence and quality of life.
- Broad Market Outlook: Crohn's disease is a chronic inflammatory condition that significantly impacts patients' quality of life, and AbbVie's ongoing investment and innovative solutions aim to elevate the standard of care, which is expected to further drive the company's growth in the global immunotherapy 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: 211.320
Low
223.00
Averages
252.00
High
289.00
Current: 211.320
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.
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- Investment Expansion: The company announced a $1.4 billion investment to build a pharmaceutical manufacturing campus in North Carolina and a $380 million investment for two new plants in North Chicago, aimed at enhancing production capacity to meet future product demand and solidifying its market position.
- Guidance Upgrade: AbbVie raised its full-year adjusted earnings per share guidance to between $14.08 and $14.28, with total net revenues expected to be approximately $67.3 billion, reflecting a positive outlook driven by key products like Skyrizi and Rinvoq.
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See More
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- Immunology Product Performance: Global net revenues from the immunology portfolio were $7.290 billion, up 16.4%, with Skyrizi generating $4.483 billion, Rinvoq $2.119 billion, and Humira $688 million, demonstrating the driving force of new products in the company's growth.
- Adjusted EPS Guidance Raised: AbbVie raised its adjusted diluted EPS guidance for 2026 from $13.96-$14.16 to $14.08-$14.28, despite accounting for a $0.41 per share impact from acquisition-related expenses, reflecting the company's confidence in future performance.
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See More
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- 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
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- Laboratory Support: Award recipient RIME Therapeutics will receive one year of laboratory and office space, including access to shared equipment and services, significantly enhancing its research capabilities and accelerating drug discovery processes.
- Industry Impact: RIME Therapeutics focuses on developing therapies for inflammation and immunology using its function-first Disruptide platform, which aims to address critical challenges in drug discovery and expedite the development of new therapies.
- Strategic Collaboration Significance: This award not only underscores AbbVie's commitment to fostering a thriving biotech ecosystem in Quebec but also supports Canadian life sciences companies in becoming globally competitive through infrastructure and mentorship.
See More
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- Equinix Upgrade: Raymond James upgraded Equinix from Market Perform to Strong Buy, citing a robust recovery driven by AI-based demand after last year's adjustments, indicating a strong market rebound potential for the company.
- SiteOne's Positive Outlook: Deutsche Bank upgraded SiteOne from Hold to Buy, anticipating a guidance beat with a price target of $160, implying a 32% upside, reflecting market recognition of its attractive low valuation.
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See More
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- Funding Challenges: Despite SoftBank's commitment of tens of billions to the AI sector, investors have raised concerns about how the company will fund these investments, particularly its backing of unprofitable OpenAI, which could impact Roze's IPO plans.
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See More
