AbbVie Extends Reach Across Dermatology Markets With Dual Regulatory Wins

On Friday, the U.S.

Food and Drug Administration (FDA) approved AbbVie Inc.’s (NYSE: ABBV ) SKYRIZI (risankizumab-rzaa) for children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis.

A new 55 mg pre-filled syringe (PFS) has also been approved to support weight-based dosing for patients weighing less than 40 kg, while the currently available 150 mg PFS and Pen are approved for patients weighing 40 kg or greater.

Read Also: AbbVie’s Costly Apogee Acquisition Has Long-Term Upside: Analyst Data Supporting SKYRIZI Pediatric Approvals The pediatric psoriasis approval is supported by data from the Phase 3 OptIMMize psoriasis clinical trial program. “At Week 16 in part 2 of the OptIMMize psoriasis clinical trial program, risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment,” said Amy Paller, study investigator in the OptIMMize program. “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.” European Regulators Back RINVOQ For Additional Dermatology Uses Separately, on Monday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of AbbVie’s upadacitinib (RINVOQ; 15 mg, once daily) for adult and adolescent patients with non-segmental vitiligo.

If approved, upadacitinib is expected to be the first systemic medication for patients with non-segmental vitiligo.

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 48.

The CHMP also recommended approving upadacitinib (15 mg and 30 mg, once daily) for adult and adolescent patients with severe alopecia areata.

The CHMP positive opinion is supported by data from the ongoing Phase 3 UP-AA clinical program.

Both the 15 mg and 30 mg doses of upadacitinib in each study met the primary endpoint of SALT score ≤ 20 at week 24, with significantly more patients achieving ≥ 80% scalp hair coverage compared with placebo.

Key secondary endpoints were also met for both doses in both studies, including complete scalp hair regrowth (SALT = 0) at week 24.

AbbVie Technical Picture Remains Strong But Overbought AbbVie stock edged higher on Monday, outperforming the broader healthcare sector.

ABBV is trading roughly 11% above its 20-day simple moving average of $227.72 and about 14% above its 200-day simple moving average of $221.47.

While that confirms strong upward momentum, it also increases the likelihood of short-term consolidation.

The relative strength index stands at 75.80, placing the stock in overbought territory.

An RSI above 70 typically indicates strong buying momentum but can also signal that a stock is becoming stretched.

The longer-term trend remains mixed.

The 50-day moving average is still below the 200-day moving average following a bearish “death cross” in April.

However, the 20-day moving average remains above the 50-day average, suggesting shorter-term momentum continues to improve.

Technical support is near $209.50, where buyers previously stepped in during the spring pullback.

Earnings And Analyst Outlook AbbVie is scheduled to report second-quarter results on July 31.

Wall Street expects earnings of $3.77 per share, up from $2.97 a year earlier, on revenue of $16.77 billion compared with $15.42 billion last year.

The stock trades at about 124 times earnings, reflecting a premium valuation.

Analysts maintain an overall Buy rating with an average price forecast of $257.09.

Recent research includes Piper Sandler maintaining an Overweight rating with a $298 price forecast, Canaccord Genuity raising its price forecast to $273 while reiterating Buy, and Evercore ISI maintaining an Outperform rating with a $235 price forecast.

ABBV Stock Price Activity: AbbVie shares were up 0.16% at $253.76 at the time of publication on Monday, according to Pro data.

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