AbbVie (AbbVie (ABBV)) just had a pretty good week in the regulatory world. On Friday, the FDA approved Skyrizi (risankizumab-rzaa) for kids aged six and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis. And on Monday, European regulators gave a thumbs-up to Rinvoq (upadacitinib) for two more skin conditions: vitiligo and alopecia areata. That's a lot of regulatory wins in a short span, and it shows AbbVie is serious about expanding its dermatology footprint.
Let's start with the FDA news. Skyrizi was already approved for adults with plaque psoriasis, but now it's available for children who need systemic therapy or phototherapy. The approval also includes a new 55 mg pre-filled syringe for weight-based dosing in patients under 40 kg. For kids who weigh 40 kg or more, the existing 150 mg syringe or pen works fine. This is a nice touch—pediatric dosing isn't one-size-fits-all, and having a lower-dose option makes life easier for doctors and families.
The data behind this comes from the Phase 3 OptIMMize trial program. At week 16, kids treated with risankizumab showed meaningful improvements in skin clearance, measured by sPGA and PASI scores, and those results held up over time with continued treatment. Dr. Amy Paller, a study investigator, put it well: "These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with plaque psoriasis or psoriatic arthritis."
Now, across the Atlantic, the European Medicines Agency's CHMP adopted a positive opinion for Rinvoq in two new indications. First, for non-segmental vitiligo in adults and adolescents—if approved, this would be the first systemic medication for vitiligo in the EU. That's a big deal because vitiligo treatment has mostly been limited to topical creams and light therapy. The CHMP opinion is backed by the Phase 3 Viti-Up studies, where Rinvoq hit both co-primary endpoints: at least 50% improvement in total body repigmentation and at least 75% improvement in facial repigmentation from baseline at week 48.
Second, the CHMP also recommended Rinvoq for severe alopecia areata in adults and adolescents, at both 15 mg and 30 mg doses. The data comes from the ongoing Phase 3 UP-AA program, where both doses met the primary endpoint of SALT score ≤ 20 at week 24—meaning patients achieved at least 80% scalp hair coverage. Key secondary endpoints, including complete scalp hair regrowth (SALT = 0), were also met. So, if you're counting, that's three potential new uses for Rinvoq in Europe, pending final approval from the European Commission.
Investors seem to like what they're seeing. AbbVie stock edged up 0.16% on Monday to $253.76, outperforming the broader healthcare sector. But the technical picture is a bit mixed. The stock is trading about 11% above its 20-day moving average and 14% above its 200-day moving average—strong momentum, but also a sign that it might be due for a breather. The relative strength index is at 75.8, which is overbought territory. That doesn't mean the stock is about to crash, but it does suggest that the recent rally might be getting a little stretched.
On the longer-term trend, there's a bit of a tug-of-war. The 50-day moving average is still below the 200-day moving average, a hangover from the bearish "death cross" in April. But the 20-day moving average is above the 50-day, which suggests short-term momentum is improving. Support sits around $209.50, where buyers stepped in during the spring pullback.
Looking ahead, AbbVie is scheduled to report second-quarter earnings on July 31. Wall Street expects earnings of $3.77 per share, up from $2.97 a year ago, on revenue of $16.77 billion, compared with $15.42 billion last year. The stock trades at about 124 times earnings, which is a premium valuation, but analysts are still bullish. The average price target is $257.09, with a consensus Buy rating. Recent analyst notes include Piper Sandler maintaining an Overweight rating with a $298 target, Canaccord Genuity raising its target to $273 with a Buy, and Evercore ISI keeping an Outperform rating with a $235 target.
So, AbbVie is firing on all cylinders: regulatory wins, a strong pipeline, and analyst support. The only question is whether the stock's momentum can hold until earnings, or if it needs a little consolidation first. Either way, the dermatology market just got a lot more interesting.













