A Tiny Biotech Just Beat AbbVie's $17 Billion Drug. Should Investors Be Worried?

AbbVie's (NYSE: ABBV) financial results have been pretty strong lately. In its first-quarter update released on April 29, it generated $15 billion in revenue -- above its own guidance of $14.7 billion -- with the top line increasing 12.4% year over year. The drugmaker's shares jumped on the heels of its earnings release. AbbVie's immunology segment is currently doing the heavy lifting, with its two most important growth drivers, Skyrizi and Rinvoq, continuing to exceed expectations.

But what if one of them encounters significant competition soon? That's what some investors believe might happen, given recent clinical progress by Oruka Therapeutics (NASDAQ: ORKA), a clinical-stage biotech. Is it time to worry about AbbVie's growth pillars?

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Challenging a giant

AbbVie's Skyrizi is approved to treat moderate-to-severe plaque psoriasis (a chronic disease that causes itchy, thick patches of dry skin), among other conditions. Last year, it generated $17.6 billion in revenue, well above Rinvoq's $8.3 billion in sales. What's more, Skyrizi's revenue grew faster, 49.9% year over year, compared to Rinvoq's 39.1% year over year increase. As of the fourth quarter of 2025, Skyrizi had a more than 45% share of the U.S. biologic psoriasis market, which includes plaque psoriasis as its largest segment.

It's also worth noting that plaque psoriasis was Skyrizi's very first approval before it earned label expansions in other niches. All of this tells us that the plaque psoriasis market is one of the most important for the medicine. It is a competitive one, but Skyrizi has established itself as an undisputed leader. But what if that changes?

On April 27, Oruka Therapeutics reported strong results from a phase 2a clinical trial of ORKA-001 in moderate-to-severe plaque psoriasis. For context, the PASI (Psoriasis Area Severity Index) score is used to measure the severity of the disease. A PASI score of 100 means complete clearing of the skin. During Oruka's phase 2a study, 40 out of 63 (63.5% of participants) achieved a PASI score of 100 at week 16.

Meanwhile, Skyrizi typically achieved PASI 100 rates of up to 51% in clinical trials. This suggests that ORKA-001 may be more effective. It is also being developed as a long-acting option that could be administered once a year. Skyrizi is given every 12 weeks for maintenance dosing for plaque psoriasis patients. It is for all those reasons that the market cheered Oruka's results and sent the stock flying. The company's shares are up by 134% this year. AbbVie has moved in the opposite direction, with its stock down 11% to date. And although the pharmaceutical giant climbed following its recent quarterly update, it has already lost that momentum.

Should investors give up on AbbVie?

AbbVie preparing to face even more competition -- potentially from a more effective drug -- for its biggest growth driver sounds scary. However, it will take some time before ORKA-001 hits the market, and that's if it goes that far. No matter how strong phase 2a results were, there is the very real possibility that ORKA-001 will flop in late-stage clinical trials. It wouldn't be the first time -- or even the second -- something like that happens to a clinical-stage biotech company. And even if ORKA-001 earns approval and takes some of Skyrizi's market share eventually, it shouldn't be a death blow to the franchise, given that it is approved in other indications and could earn additional label expansions.

Meanwhile, AbbVie has several other growth drivers, even beyond its immunology segment. They include Qulipta for migraine as well as its Botox franchise. AbbVie also has a deep pipeline and should launch new products to reduce its reliance on its immunology business. That includes a promising early stage weight loss candidate. That's why AbbVie's prospects remain attractive, especially considering its excellent dividend program. AbbVie is a Dividend King, or a corporation with 50 or more consecutive dividend hikes. Despite recent developments, the company remains a top pick for long-term income seekers.

Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends AbbVie. The Motley Fool has a disclosure policy.