AbbVie reports positive results for alopecia areata treatment

NORTH CHICAGO - AbbVie (NYSE:ABBV), a prominent player in the biotechnology industry with a market capitalization of $369 billion, announced Thursday that its drug upadacitinib (RINVOQ) met its primary endpoint in the second of two pivotal Phase 3 clinical trials for severe alopecia areata, showing significant hair regrowth in treated patients. According to InvestingPro data, the company’s strong financials, including a 71% gross profit margin, support its robust drug development pipeline.

The study demonstrated that 45.2% of patients receiving the 15 mg dose and 55.0% of those on the 30 mg dose achieved at least 80% scalp hair coverage after 24 weeks of treatment, compared to just 1.5% of patients on placebo.

Additionally, 35.2% and 45.8% of patients on the 15 mg and 30 mg doses respectively reached 90% or more scalp hair coverage, versus 0.7% in the placebo group. The trial also met key secondary endpoints related to improvements in eyebrows and eyelashes.

"These positive results strengthen the growing body of evidence supporting the potential of upadacitinib to improve the lives of people with AA," said Kori Wallace, vice president of global immunology clinical development at AbbVie, according to the company’s press release. With annual revenue of $58.3 billion and 13 analysts recently revising earnings estimates upward, AbbVie continues to demonstrate strong market performance. InvestingPro subscribers can access over 30 additional key metrics and insights about AbbVie’s financial health and growth potential.

The safety profile was generally consistent with that observed in approved indications. The most common treatment-emergent adverse events included upper respiratory tract infection, acne, increased blood creatine phosphokinase, and nasopharyngitis.

Serious adverse events occurred in 1.9% and 1.8% of patients in the 15 mg and 30 mg groups respectively, compared to 0.7% in the placebo group. No deaths, major adverse cardiovascular events, or venous thromboembolic events were reported.

Alopecia areata is an autoimmune disease that causes hair loss on the scalp, face, and body. The results from this study align with the previously reported findings from the first parallel replicate study of the Phase 3 program.

Upadacitinib is not currently approved for use in alopecia areata, and its safety and efficacy for this indication have not yet been evaluated by regulatory authorities, according to the company statement. While trading near its 52-week high, detailed analysis available in the InvestingPro Research Report suggests the stock may be currently overvalued, though the company maintains strong fundamentals and growth prospects.

In other recent news, AbbVie has completed its acquisition of Capstan Therapeutics, bringing Capstan’s lead asset CPTX2309 into its portfolio. This asset, currently in Phase 1 clinical trials, is a targeted lipid nanoparticle therapy for B cell-mediated autoimmune diseases. Additionally, AbbVie announced a $195 million investment to expand its active pharmaceutical ingredient manufacturing capabilities in North Chicago, enhancing its production in neuroscience, immunology, and oncology medicines.

Cantor Fitzgerald raised its price target for AbbVie to $215, citing strong quarterly results and impressive Skyrizi sales. Piper Sandler assumed coverage of AbbVie with an Overweight rating and a price target of $231, highlighting the company’s favorable position regarding loss of exclusivity exposure. Meanwhile, Bernstein reiterated a Market Perform rating with a $203 price target after AbbVie’s second-quarter earnings report exceeded expectations in both revenue and earnings per share. These developments reflect AbbVie’s strategic moves and analyst perspectives.

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