AbbVie's Rinvoq Achieves Phase 3 Success in Severe Alopecia Areata: Undervalued or Not?

Monday, Aug 25, 2025 6:44 am ET1min read

AbbVie announced positive results from late-stage studies of upadacitinib (Rinvoq) for severe alopecia areata, achieving primary and secondary endpoints with significant hair regrowth. The company is preparing Rinvoq for potential regulatory submission, further strengthening its immunology position and introducing a new growth opportunity. AbbVie's shares have risen 11% over the past month and are up 10% for the year, with continued robust growth in immunology driving sustained top-line revenue growth. The community narrative views AbbVie as slightly undervalued, with a fair value of $214.77.

AbbVie (NYSE: ABBV) has announced positive topline results from the second replicate study of the pivotal Phase 3 UP-AA clinical program, which evaluates the safety and efficacy of upadacitinib (RINVOQ®) in adult and adolescent patients with severe alopecia areata (AA). The study, conducted at 248 sites worldwide, randomized 1,399 participants with severe AA aged 12 to 64 [1].

In the study, upadacitinib achieved the primary endpoint, demonstrating that 45.2% and 55.0% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage (SALT score ≤ 20) at week 24 compared to 1.5% of patients receiving placebo (p0.001). Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤ 10) and complete scalp hair coverage (SALT=0) at week 24, were also met [1].

The safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period (Period A) was generally consistent with that observed in approved indications. Treatment-emergent serious adverse events occurred in 1.9% and 1.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and 0.7% in the placebo group [1].

AbbVie's shares have risen 11% over the past month and are up 10% for the year, with continued robust growth in immunology driving sustained top-line revenue growth. The community narrative views AbbVie as slightly undervalued, with a fair value of $214.77 [1].

References:
[1] https://news.abbvie.com/2025-08-21-AbbVie-Announces-Positive-Topline-Results-from-Second-Phase-3-UP-AA-Trial-Evaluating-Upadacitinib-RINVOQ-R-for-Alopecia-Areata

AbbVie's Rinvoq Achieves Phase 3 Success in Severe Alopecia Areata: Undervalued or Not?

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