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NORTH CHICAGO - The U.S. Food and Drug Administration has approved an updated indication for AbbVie’s (NYSE:ABBV) RINVOQ (upadacitinib) for treating adults with moderately to severely active ulcerative colitis and Crohn’s disease, the company announced Monday. AbbVie, a prominent player in the biotechnology industry with a market capitalization of $412.7 billion, has demonstrated strong financial health according to InvestingPro analysis.
The updated indication allows physicians to prescribe RINVOQ for patients who have received at least one approved systemic therapy when tumor necrosis factor (TNF) blockers are clinically inadvisable. Previously, RINVOQ was only indicated for patients who had an inadequate response or intolerance to TNF blockers. This expansion could contribute to AbbVie’s already impressive annual revenue of $58.3 billion. InvestingPro subscribers can access detailed analysis of AbbVie’s growth potential through comprehensive Pro Research Reports, along with 14 additional ProTips about the company’s performance.
"This label update gives healthcare providers the option to prescribe RINVOQ for patients with moderately to severely active inflammatory bowel disease after the use of one approved systemic therapy if TNF blockers are deemed clinically inadvisable by the prescribing physician," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development at AbbVie. The company’s strong market position is reflected in its consistent dividend payments, having maintained and raised dividends for 13 consecutive years.
RINVOQ, a JAK inhibitor, carries warnings about serious side effects including infections, increased risk of death in people over 50 with heart disease risk factors, cancer, major cardiovascular events, blood clots, and allergic reactions.
Inflammatory bowel disease, which includes ulcerative colitis and Crohn’s disease, is characterized by chronic inflammation of the gastrointestinal tract. These progressive conditions can cause persistent diarrhea, abdominal pain, rectal bleeding, and other symptoms that significantly impact patients’ quality of life.
The approval was based on a supplemental new drug application submitted by AbbVie, according to the company’s press release statement. The stock is currently trading near its 52-week high, with a gross profit margin of 71.25% demonstrating the company’s operational efficiency.
In other recent news, AbbVie has announced several significant developments that may interest investors. The company reported that its Phase 2 trial for onabotulinumtoxinA (BOTOX) in treating upper limb essential tremor met its primary endpoint, demonstrating statistically significant improvement compared to a placebo. Additionally, AbbVie has updated its 2025 earnings guidance to reflect a $2.7 billion expense related to acquired in-process research and development, which is expected to impact earnings per share by $1.50. On the expansion front, AbbVie has commenced a $70 million project to increase its biologics manufacturing capacity at the AbbVie Bioresearch Center in Worcester, Massachusetts.
Analyst firms have also shown confidence in AbbVie’s performance. Piper Sandler raised its price target for AbbVie to $284, citing strong performance across the company’s portfolio, excluding aesthetics. Meanwhile, Cantor Fitzgerald increased its price target to $250, highlighting the strong performance of the drug Skyrizi, which exceeded consensus estimates by $51 million. These recent developments indicate a period of growth and strategic investment for AbbVie.
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