Track market-moving stories before they get noisy

The market expects AbbVie (ABBV - Free Report) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.

The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on July 31. On the other hand, if they miss, the stock may move lower.

While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.

Zacks Consensus EstimateThis drugmaker is expected to post quarterly earnings of $3.66 per share in its upcoming report, which represents a year-over-year change of +23.2%.

Revenues are expected to be $16.81 billion, up 9% from the year-ago quarter.

Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 0.11% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.

Price, Consensus and EPS Surprise

Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for AbbVie?For AbbVie, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -1.01%.

On the other hand, the stock currently carries a Zacks Rank of #3.

So, this combination makes it difficult to conclusively predict that AbbVie will beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that AbbVie would post earnings of $2.62 per share when it actually produced earnings of $2.65, delivering a surprise of +1.15%.

Over the last four quarters, the company has beaten consensus EPS estimates four times.

Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

AbbVie doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.

On June 22, AbbVie (ABBV +0.04%) announced that it would acquire Apogee Therapeutics (APGE 0.06%) for $10.9 billion in cash. Some investors celebrated the move, since it will add zumilokibart, a promising investigational medicine for eczema, to AbbVie's lineup and help it solidify its leadership in immunology. However, others may fear that, given how much it will spend on this buyout, the transaction may impact AbbVie's dividend program, one of the company's key selling points. My view is that income seekers have nothing to worry about. Here's why.

Image source: The Motley Fool.

A precedent that speaks volumes Expensive acquisitions can put downward pressure on a company's dividend program if they significantly reduce the cash available to be returned to shareholders. With AbbVie ending 2025 with $17.8 billion in free cash flow, some fear that this is what will happen. But it's worth noting that AbbVie is a Dividend King, or a corporation with 50 (or more) consecutive years of dividend increases, once we factor in the time it spent under Abbott Laboratories' wing.

Management is committed to maintaining this streak, because if AbbVie misses a single year of dividend increase, it will have to start from scratch and hope to join the ranks of Dividend King again in another 50 years. Besides, AbbVie will fund the acquisition with debt, meaning it won't deplete its cash balance.

It's worth considering how the largest acquisition in AbbVie's history -- and one of the largest ever in the pharmaceutical industry -- impacted its dividend program. The company bought Allergan for $63 billion in a mix of cash and stock in May 2020. This massive transaction did not harm AbbVie's dividend. Since 2020, the drugmaker's payouts have increased by 46.6%.

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The business is improving AbbVie's acquisition of Apogee Therapeutics may also lead to the company launching zumilokibart. This product could help drive solid revenue, earnings, and free cash flow growth, thereby strengthening the business and helping it maintain its dividend program. Once again, that's arguably what the Allergan acquisition did for AbbVie. The drugmaker was able to expand and diversify its lineup thanks to it, and products such as its Botox franchise and Vraylar, a schizophrenia medicine, helped it move beyond Humira's patent cliff.

So, this buyout will arguably be a net positive for AbbVie, especially if zumilokibart becomes as successful as the company expects. In the meantime, AbbVie is still depending on its two biggest growth drivers, Skyrizi and Rinvoq, to post strong financial results. And the company boasts several other exciting pipeline candidates, including in the fast-growing weight loss market. AbbVie remains a strong buy, given all these factors, especially for dividend-seeking investors.

AbbVie (ABBV 0.73%) is listed as a Dividend King, but in fairness, it has only been a stand-alone company since it was spun off from Abbott (ABT 0.46%) at the start of 2013. AbbVie hasn't been around for the 50 years required to qualify as a Dividend King; instead, it has inherited Abbott's track record. Still, it has increased its dividend annually since the spin-off.

So the real story is what AbbVie has been doing to maintain its place among the Dividend Kings. The most recent answer to that is to agree to buy Apogee Therapeutics (APGE +0.06%). Here's why that's so important for the future.

Image source: Getty Images.

AbbVie has a strong portfolio, for now AbbVie has a strong portfolio of drugs. Biologics are a big part of its business, with Humira, Skyrizi, and Rinvoq all notable products. The interesting thing about this trio is that Humira lost patent protection in 2023, leading to a decline in its revenues. But Skyrizi and Rinvoq are newer drugs and helping to pick up the slack. This is how the pharmaceutical sector works: companies like AbbVie are always on the lookout for new drugs to replace older ones that will eventually lose patent protection.

The purchase of Apogee Theraputics brings with it a number of attractive drug candidates. AbbVie highlighted zumilokibart, a late-stage drug for atopic dermatitis, in its release. This is a core therapeutic area for AbbVie. But the release also noted Apogree's pipeline of drugs in the respiratory space, which could help to build AbbVie's presence in this area.

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Simply put, this $10.9 billion deal highlights AbbVie's ability to support its drug pipeline, which is what will allow it to maintain its Dividend King status over time. What's interesting here, and sets AbbVie apart from most of its competitors, is that the company also makes Botox, which was an acquired product as well. Botox is off-patent, but it has an important brand name in the cosmetic space. That gives the company a consistent revenue stream, which is unusual in the drug space. And it makes Botox a good example of AbbVie's ability to make strong acquisitions.

Is AbbVie a dynasty in the making? Some of the world's best-known drug companies have been in business for over 100 years. AbbVie obviously isn't at that point yet. However, the Apogee Therapeutics acquisition shows, again, why it can compete with much older drug-makers. With an attractive 2.7% dividend yield, AbbVie is a worthwhile deep dive for conservative dividend lovers who think in decades.

Key Takeaways AbbVie won EU approval for Tepkinly R2 in adult patients with R/R FL after prior therapy.ABBV's phase III study showed a 79% lower risk of progression or death versus R2 alone, with higher responses.AbbVie and Genmab continue to advance epcoritamab across blood cancers through late-stage clinical studies. AbbVie (ABBV - Free Report) announced that the European Commission (EC) approved the expanded use of Tepkinly (epcoritamab) for the relapsed or refractory follicular lymphoma (R/R FL) indication. The EC approved the drug in combination with rituximab and lenalidomide (Tepkinly+R2) for adult patients with R/R FL after at least one line of systemic therapy.

The approval represents Tepkinly's third indication in the European Union (EU) and marks the first EU approval of a bispecific-based, chemotherapy-free therapy for second-line relapsed or refractory follicular lymphoma.

To remind investors, ABBV markets epcoritamab under the brand name Epkinly in the United States and Japan, and as Tepkinly in the EU.

Tepkinly is already approved as monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma and R/R FL after two or more lines of systemic therapy in the EU.

The FDA approved Epkinly in combination with rituximab and lenalidomide for a similar indication in the United States in November 2025.

Year to date, ABBV shares have rallied 11.5% compared with the industry’s 13.8% growth.

Image Source: Zacks Investment Research

ABBV's Tepkinly Combo EU Nod Backed by Phase III StudyThe EU approval is based on data from the pivotal phase III EPCORE FL-1 study, which demonstrated that Tepkinly+R2 significantly improved outcomes compared to the standard-of-care R2 alone in second-line patients with R/R FL. The combination reduced the risks of disease progression or death by 79% and achieved higher overall and complete response rates versus R2 alone. Its safety profile was consistent with the known profiles of the previous individual therapies, with no new safety signals identified.

The most common adverse events included neutropenia, rash, infections, fatigue, diarrhea, COVID-19 and cytokine release syndrome, while serious adverse events occurred in 44% of patients.

Follicular lymphoma is a slow-growing type of B-cell non-Hodgkin lymphoma and the second most common subtype of the disease. Although treatment can induce remission, FL remains incurable, with many patients experiencing relapses and requiring additional therapies over time. The disease is more prevalent in European populations than in non-European populations.

AbbVie has partnered with Genmab (GMAB - Free Report) to jointly develop epcoritamab under the companies' oncology collaboration agreement. While both companies share commercialization rights in the United States and Japan, AbbVie is responsible for commercialization in other global markets. AbbVie and Genmab continue to advance their global development and regulatory expansion while evaluating the therapy as a monotherapy and in combination regimens across multiple hematologic malignancies through several late-stage clinical studies.

ABBV’s Zacks Rank & Stocks to ConsiderAbbVie currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) and Amarin Corporation (AMRN - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents per share. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 8% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.

Over the past 60 days, loss per share estimates for Amarin have narrowed from $15.20 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $13.00 to 51 cents for 2027. AMRN shares have risen 12.5% year to date.

Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.

Key Takeaways AbbVie's Q2 results will hinge on Skyrizi and Rinvoq as Humira sales continue to decline.ABBV expects Skyrizi and Rinvoq momentum, backed by market share gains, to lift immunology sales.AbbVie is expanding in oncology and neuroscience while facing immunology competition from J&J and Lilly. AbbVie (ABBV - Free Report) remains a dominant force in the immunology segment, from where it generates nearly half of its top line. This growth is mainly driven by the continued uptake of its two blockbuster medications, Skyrizi and Rinvoq, which have helped the company return to top-line growth despite the U.S. loss of exclusivity for its legacy drug, Humira, in 2023. Investors’ focus will primarily be on the sales performance of these two drugs when AbbVie reports its second-quarter 2026 results on July 31.

The Zacks Consensus Estimate for Skyrizi sales is pegged at $5.49 billion, while the same for Rinvoq stands at $2.47 billion. Continued momentum from these therapies, supported by market share gains, is expected to drive immunology sales in the quarter. Meanwhile, Humira sales are expected to continue their downward trajectory, with the Zacks Consensus Estimate pegged at $744 million for the quarter.

AbbVie successfully launched Skyrizi and Rinvoq across Humira's major indications, as well as a distinct new indication, atopic dermatitis. Both drugs have delivered strong performance across approved indications, especially in the popular inflammatory bowel disease (IBD) space, which includes ulcerative colitis (UC) and Crohn’s disease (CD).

The company has also been expanding its presence beyond immunology into oncology and neuroscience. In recent years, ABBV has added Elahere, Emrelis and, most recently, Decnupaz, bringing its total number of oncology therapies to six. Growth in its neuroscience segment has also been supported by the increasing uptake of its migraine drugs, Ubrelvy and Qulipta, as well as the Parkinson’s disease drug Vyalev.

ABBV’s Competition in the Immunology SpaceThe immunology market is highly competitive. A key player in this area is Johnson & Johnson (JNJ - Free Report) , which already markets two blockbuster drugs — Stelara and Tremfya. These medications are approved across multiple immunology indications, including UC and CD. Since Stelara lost U.S. patent exclusivity last year, J&J has shifted its focus to Tremfya. It recently secured approval for a new immunology drug, Icotyde, to treat moderate-to-severe plaque psoriasis. While still in the early stages of launch, the drug could pose a competitive threat to Skyrizi.

Another pharma giant expanding its presence in immunology is Eli Lilly (LLY - Free Report) , following the FDA approval of Omvoh for the UC indication in late 2023. Omvoh marked LLY’s first immunology drug approved for a type of IBD in the United States, playing a key role in expanding its immunology portfolio. The Eli Lilly drug is approved for the CD indication.

ABBV’s Price Performance, Valuation and EstimatesShares of AbbVie have outperformed the industry year to date, as seen in the chart below.

Image Source: Zacks Investment Research

From a valuation standpoint, AbbVie is trading at a discount to the industry. Based on the price/earnings (P/E) ratio, the company’s shares currently trade at 17.2 times forward earnings, lower than its industry’s average of 19.1.

Image Source: Zacks Investment Research

The bottom-line estimate per share for 2026 has declined from $14.30 to $14.28, while the 2027 estimate has fallen from $16.30 to $16.03 over the past 30 days.

Image Source: Zacks Investment Research

AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A bipartisan group of United States lawmakers has opened national security investigations into whether five major pharmaceutical companies, including Merck and AbbVie, were involved in clinical trials conducted in China that may have supported the country’s military capabilities, according to a Reuters report.

The inquiry, led by Republican Representative John Moolenaar of Michigan, chair of the House Select Committee on China, focuses on whether the drugmakers conducted adequate due diligence and maintained sufficient data protection standards at trial sites in China.

In letters dated Monday and first reported by Reuters on Tuesday, lawmakers requested detailed information from Merck & Co Inc (NYSE:MRK, XETRA:6MK) and Abbvie Inc (NYSE:ABBV) by July 17, including documentation on research practices, safeguards, and oversight mechanisms.

The scrutiny also extends to Eli Lilly and Co (NYSE:LLY), Pfizer Inc (NYSE:PFE, XETRA:PFE), and Bristol-Myers Squibb Co (NYSE:BMY, XETRA:RM, OTC:BMYMP), which received similar requests from the committee.

Lawmakers specifically asked for information related to clinical trial locations in China, including sites in the Xinjiang region and military-affiliated hospitals, and raised broader concerns about whether sensitive biomedical data could be accessed or repurposed in ways that pose national security risks.

Merck stated that patient safety and ethical integrity are central to its clinical research operations and said it adheres to global regulatory standards governing clinical trials. AbbVie declined to comment. Pfizer confirmed receipt of the letter but did not provide further comment. Bristol Myers Squibb and Eli Lilly did not immediately respond to requests for comment, according to the Reuters report.

The Chinese embassy in Washington rejected the premise of the investigation, saying in an email that there is “nothing credible” in the committee’s actions and reiterating opposition to what it described as efforts to politicize trade and technology issues.

The developments add to growing US-China tensions over scientific collaboration, particularly in sectors involving sensitive data and dual-use technologies, where commercial research may intersect with national security concerns.

The companies’ shares initially moved lower following the news, but were little changed by the early afternoon.

If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune disease Positive CHMP opinion is supported by data from the Phase 3 Viti-Up clinical studies, in which upadacitinib achieved both co-primary endpoints demonstrating at least a 50% improvement in total body repigmentation (T-VASI 50) and at least a 75% improvement in facial repigmentation (F-VASI 75) from baseline at week 481 , /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; 15 mg, once daily) for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV). The final European Commission decision is expected in the coming months. If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo.

"Vitiligo is an autoimmune skin disease with high stigma and significant burden to patients with limited treatment options available," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "A positive opinion for upadacitinib in non-segmental vitiligo is an important step forward in providing patients with a systemic treatment option."

The CHMP positive opinion is supported by data from the ongoing Phase 3 Viti-Up clinical program, including two replicate, randomized, placebo-controlled, double-blind studies evaluating the efficacy and safety of upadacitinib in adult and adolescent patients with NSV. Upadacitinib 15 mg met both co-primary endpoints and key secondary endpoints, with significant improvements in total body and facial repigmentation.1 The safety profile of upadacitinib 15 mg was consistent with that observed in approved indications, with no new safety signals.1

Upadacitinib is approved in the European Union (EU) for the treatment of adults and adolescents with atopic dermatitis, and adults with radiographic axial spondylarthritis, non-radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis. Use of upadacitinib in NSV is not currently approved in the EU.

About Vitiligo
Vitiligo is a chronic, autoimmune disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches of skin that can appear anywhere on the body and at any time.2 It imposes a significant psychosocial burden, profoundly affecting an individual's confidence, identity and daily life.3 Non-segmental vitiligo (NSV), the most common form of vitiligo afflicting approximately 84% of patients, is marked by symmetrical and bilateral depigmented white patches and is prone to unpredictable progression even after long periods of stability.2,4-6 While location varies, many patients report patches on critical areas such as the face, feet, hands and groin. Despite its immune-mediated nature, vitiligo is often considered primarily a cosmetic problem, which can lead to stigma and psychological impact on patients' lives.7-9 Vitiligo management is anchored in three primary treatment goals: disease stabilization, repigmentation, and maintaining repigmentation.10,11 There are currently no approved systemic medicines specifically indicated for these treatment goals in vitiligo.

About Viti-Up Clinical Trials
Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate Phase 3 studies (Study 1 and Study 2) with independent randomization, investigative sites, data collection, analysis and reporting for each study. The trials were designed to evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with non-segmental vitiligo (NSV) who were eligible for systemic therapy. In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks. The two trials randomized 614 participants with NSV across 90 sites worldwide. More information on these trials can be found at www.clinicaltrials.gov (NCT06118411).

The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV.

The secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, and the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV.

About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in non-segmental vitiligo is not approved; its safety and efficacy are under regulatory review by the U.S. FDA and the European Medicines Agency.

EU Indications and Important Safety Information about RINVOQ® (upadacitinib)12

Indications

Rheumatoid arthritis

RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis

RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

Axial spondyloarthritis

Non-radiographic axial spondyloarthritis (nr-axSpA)

RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Giant cell arteritis

RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

Atopic dermatitis

RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.

Ulcerative colitis

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Crohn's disease

RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Important Safety Information

Contraindications
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

Special warnings and precautions for use
RINVOQ should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
 - patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers);
 - patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another Janus Kinase (JAK) inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.

Immunosuppressive medicinal products
Use in combination with other potent immunosuppressants is not recommended.

Serious infections
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.

Tuberculosis
Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.

Viral reactivation
Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.

Vaccination
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.

Malignancy
Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.

Hematological abnormalities
Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.

Gastrointestinal perforations
Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.

Major adverse cardiovascular events
MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.

Lipids
RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.

Hepatic transaminase elevations
Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.

Venous thromboembolism
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose‑dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.

Retinal vein occlusion
Retinal vein occlusion has been reported in patients treated with JAK inhibitors, including upadacitinib. Patients should be advised to promptly seek medical care in case they experience symptoms suggestive of retinal vein occlusion.

Hypersensitivity reactions
Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.

Hypoglycemia in patients treated for diabetes
There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs.

Medication Residue in Stool
Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response.

Giant Cell Arteritis
RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Corticosteroids should be given according to medical judgement and practice guidelines.

Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.

The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg and 30 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups.

The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.

Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ.

The most common serious adverse reactions were serious infections.

The safety profile of RINVOQ with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications.

This is not a complete summary of all safety information.

See RINVOQ full Summary of Product Characteristics (SmPC) at www.ema.europa.eu

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of actions and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.

Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 19 immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

AbbVie. Data on file ABVRRTI82545 Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7 Krüger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012;51(10):1206-1212. doi:10.1111/j.1365-4632.2011.05377.x Mazzei Weiss ME. Vitiligo: to biopsy or not to biopsy?. Cutis. 2020;105(4):189-190. Ezzedine K, Lim HW, Suzuki T, et al. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25(3):E1-13 Taneja N, Sreenivas V, Sahni K, Gupta V, Ramam M. Disease Stability in Segmental and Non-Segmental Vitiligo. Indian Dermatol Online J. 2021 Aug 2;13(1):60-63. doi: 10.4103/idoj.IDOJ_154_21. PMID: 35198469; PMCID: PMC8809159 Hlača N, Žagar T, Kaštelan M, Brajac l, Prpić-Massari L. Current concepts of vitiligo immunopathogenesis. Biomedicines. 2022;10(7):1639. doi:10.3390/biomedicines10071639 Abdel-Malek ZA, Jordan C, Ho T, Upadhyay PR, Fleischer A, Hamzavi l. The enigma and challenges of vitiligo pathophysiology and treatment. Pigment Cell Melanoma Res. 2020;33(6):778-787. doi:10.1111/pcmr.12878 Birlea SA, Goldstein NB, Norris DA. Repigmentation through melanocyte regeneration in vitiligo. Dermatol Clin. 2017;35(2):205-218. doi:10.1016/j.det.2016.11.015 van Geel N, Speeckaert R, Taïeb A, et al. Worldwide expert recommendations for the diagnosis and management of vitiligo: position statement from the International Vitiligo Task Force part 1: towards a new management algorithm. J Eur Acad Dermatol Venereol. 2023;37(11):2173-2184. doi:10.1111/jdv.19451 Seneschal J, Boniface K. Vitiligo: Current therapies and future treatments. Dermatol Pract Concept. 2023;13(4S2):e2023313S. doi:10.5826/dpc.1304S2a313 RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026 SOURCE AbbVie

Key Takeaways AbbVie gets EU approval for Skyrizi in children aged six and older with moderate-to-severe plaque psoriasis.Skyrizi's approval includes a new 55 mg pre-filled syringe for patients weighing under 40 kg.EU clears Maviret in acute HCV, making it the only treatment cleared for acute & chronic HCV in the region. AbbVie (ABBV - Free Report) announced that the European Commission (EC) has approved its blockbuster immunology drug, Skyrizi (risankizumab), for treating children and adolescents aged six years and above with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

The latest approval in the EU includes a new 55 mg pre-filled syringe designed for patients who weigh less than 40 kg, helping ensure appropriate dosing based on body weight.

The approval was based on data from the phase III OptIMMize-1 pediatric psoriasis program, which included data from two lead-in pharmacokinetic cohorts as well as data from the phase III OptIMMize-2 open-label extension study.

Skyrizi is currently approved for the treatment of adult patients with plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, both in the United States and in Europe.

Skyrizi remains a key growth driver for AbbVie. Sales of the drug soared 29.2% year over year on an operational basis to $4.48 billion in the first quarter of 2026, accounting for nearly 30% of the company’s total revenues. The drug is seeing strong performance across all its approved indications.

ABBV’s Price PerformanceYear to date, shares of AbbVie have risen 4.4% compared with the industry’s growth of 4.5%.

Image Source: Zacks Investment Research

ABBV Wins EU Nod for Maviret in Acute HCVIn a separate press release, AbbVie announced that the European Commission has approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection with compensated liver disease (with or without cirrhosis) in adults and children aged three years and above.

Following the latest nod, Maviret became the only treatment to be approved for both acute and chronic HCV infection in the European Union. The broader indication could simplify treatment decisions and support ongoing efforts to eliminate HCV across the region.

The latest nod was based on data from the phase III study, which demonstrated Maviret to be a highly efficacious treatment for patients with acute HCV infection.

Maviret is approved in the United States under the trade name Mavyret for the treatment of acute and chronic HCV infection in adults and children aged three years and older.

Mavyret sales increased 8.6% on an operational basis year over year to $351 million in the first quarter of 2026.

ABBV’s Zacks Rank & Stocks to ConsiderAbbVie currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Kiniksa Pharmaceuticals (KNSA - Free Report) , Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 EPS have increased from $1.09 to $1.24. Over the same period, EPS estimates for 2027 have risen from $1.54 to $1.70. KNSA shares have surged 44.2% year to date.

Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed in the remaining two quarters, with the average surprise being 1.53%.

Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 15.8% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 114.7% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.