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NORTH CHICAGO, Ill. - AbbVie (NYSE:ABBV) has officially applied for approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to use its drug upadacitinib for treating adults with giant cell arteritis (GCA). This autoimmune disease affects medium and large arteries, potentially leading to severe headaches, jaw pain, and vision loss.
The company's submission is backed by the Phase 3 SELECT-GCA study, which showed that upadacitinib, at a 15 mg dose with a 26-week steroid taper regimen, met its primary endpoint of sustained remission from week 12 through week 52. The study involved 428 patients and compared upadacitinib combined with a shorter steroid regimen to placebo with a longer steroid regimen. The safety profile of upadacitinib in GCA patients was generally consistent with its use in other approved indications.
GCA, often referred to as temporal arteritis, can lead to sudden and permanent vision loss if not treated promptly. It is more commonly diagnosed in Caucasian women over the age of 50, particularly between 70 and 80 years old, though it can affect men, who may experience more severe ocular manifestations of the disease.
Developed by AbbVie, upadacitinib is a selective and reversible JAK inhibitor that has been studied in various immune-mediated inflammatory diseases. While it is currently approved for other conditions such as rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis, its use for GCA has not yet been evaluated by regulatory authorities.
The SELECT-GCA study is ongoing, with a second period assessing the long-term safety and efficacy of upadacitinib in maintaining remission in patients who responded during the first phase. The applications to the FDA and EMA represent a potential new treatment option for GCA, aiming to reduce reliance on steroids, which are the standard treatment but can have significant side effects.
AbbVie's commitment to rheumatology spans over two decades, focusing on the discovery and delivery of transformative therapies. The company emphasizes the importance of providing new treatment options for diseases with limited therapies available. This submission for a new indication of upadacitinib underscores their ongoing efforts in this therapeutic area.
The information for this article is based on a press release statement.
In other recent news, AbbVie has made several significant updates. The company has adjusted its earnings outlook for 2024, citing significant research and development expenses, with the full-year guidance now standing at an adjusted diluted EPS range of $10.61 to $10.81. AbbVie has also announced the appointment of Roopal Thakkar, M.D., as the new Executive Vice President of Research & Development and Chief Scientific Officer.
In addition to these changes, AbbVie recently acquired Celsius Therapeutics for $250 million, adding the investigational drug CEL383 to its immunology portfolio. The company also launched Allē Payment Plans, aimed at making aesthetic treatments more financially accessible to patients.
On the regulatory front, AbbVie received a Complete Response Letter from the FDA regarding its New Drug Application for ABBV-951, a treatment for Parkinson's disease. In terms of analyst activity, Piper Sandler raised its price target for AbbVie from $185.00 to $190.00, maintaining an Overweight rating, while Deutsche Bank reiterated its Hold rating on AbbVie.
InvestingPro Insights
As AbbVie (NYSE:ABBV) seeks to expand the use of upadacitinib for treating giant cell arteritis, investors are closely monitoring the company's performance and prospects. With a robust market capitalization of $300.04 billion, AbbVie stands as a significant player in the biopharmaceutical sector. The company's dedication to innovation in rheumatology is underpinned by a strong financial foundation, as evidenced by its impressive gross profit margin of 69.17% over the last twelve months as of Q1 2024.
One of the notable InvestingPro Tips for AbbVie is its consistent track record of dividend growth, having raised its dividend for 11 consecutive years. This commitment to shareholder returns is complemented by a dividend yield of 3.65%, making it an attractive stock for income-focused investors. Additionally, AbbVie's valuation implies a strong free cash flow yield, suggesting that the company is generating sufficient cash to support its operations and strategic initiatives.
Despite some analysts revising their earnings expectations downwards for the upcoming period, the company's net income is expected to grow this year. This aligns with the broader outlook for AbbVie, which is trading near its 52-week high, reflecting investor confidence in its performance and future growth potential. Moreover, with a P/E ratio (adjusted for the last twelve months as of Q1 2024) of 22.83, AbbVie is trading at a high earnings multiple, indicating that the market has high expectations for its future earnings capacity.
For those interested in a deeper analysis of AbbVie and its position within the biotechnology industry, InvestingPro offers additional insights and metrics. There are 12 additional InvestingPro Tips available, which can provide valuable context for investors evaluating the company's long-term prospects. To explore these further, visit https://www.investing.com/pro/ABBV and consider using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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