Abbvie Inc Stock Price, News & Analysis

AbbVie reported its first-quarter 2023 financial results with a GAAP diluted EPS of $0.13, down 94.8% from the previous year, and an adjusted diluted EPS of $2.46, a decrease of 22.2%. Net revenues fell 9.7% to $12.225 billion, with notable declines in its Immunology and Hematologic Oncology portfolios. Humira revenue plunged 25.2% to $3.541 billion, while Skyrizi and Rinvoq saw increases of 44.7% and 47.5%, respectively. A full-year 2023 adjusted EPS guidance was raised to a range of $10.72 - $11.12, excluding future IPR&D impacts. Significant events included the approval of Rinvoq for Crohn's disease and positive Skyrizi trial results, but AbbVie also announced the withdrawal of certain U.S. approvals for Imbruvica.

AbbVie has announced positive results from its Phase 3 ELEVATE study of atogepant, evaluating its effectiveness for preventing episodic migraines in patients who have previously failed multiple oral medications. The study showed a statistically significant reduction in mean monthly migraine days (MMDs) of 4.20 days for those taking atogepant 60 mg once daily, compared to a 1.85-day reduction in the placebo group (p<0.0001). This study included 309 participants, with 56% having failed two classes of preventive medications, and demonstrated that atogepant was well tolerated, consistent with its safety profile. The results will be presented at the American Academy of Neurology Annual Meeting on April 25, 2023.

AbbVie announced that the FDA has approved QULIPTA® (atogepant) for the preventive treatment of chronic migraine in adults, making it the first and only oral CGRP receptor antagonist for this purpose.

This expanded indication offers a new treatment option for those suffering from chronic migraines, defined as experiencing headaches on 15 or more days per month.

The approval follows a Phase 3 clinical trial demonstrating a statistically significant reduction in average monthly migraine days and improvements in overall functioning.

AbbVie notably holds a competitive edge with three prescription treatments for migraine, including QULIPTA, BOTOX® (for chronic migraine), and UBRELVY® (for acute migraine attacks).

AbbVie announced the European Commission's approval of RINVOQ (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor for treating adults with moderately to severely active Crohn's disease. This marks the seventh approved indication for RINVOQ in the EU and the third for AbbVie's inflammatory bowel disease portfolio within a year. RINVOQ demonstrated significant efficacy in achieving clinical and endoscopic remission in clinical trials compared to placebo, with 35%-51% of patients achieving remission at 12 weeks. Safety data indicated results consistent with RINVOQ's known profile, with no new safety concerns reported. This approval may enhance AbbVie's market position in the ongoing treatment of inflammatory bowel diseases.

AbbVie has announced the opening of applications for the AbbVie Cystic Fibrosis Scholarship for the 2023-2024 academic year. Eligible undergraduate and graduate students living with cystic fibrosis (CF) can apply until May 24, 2023, at 11:00 a.m. U.S. Eastern Time. The scholarship awards $3,000 each to 40 students for academic excellence and community involvement. Additionally, two students will be selected as the 2023 'Thriving Students', receiving $22,000 each, with winners determined partially by public voting. Since its inception, the program has invested over $3.8 million in scholarships to support the nearly 40,000 CF patients in the U.S. This initiative demonstrates AbbVie's commitment to supporting the CF community and alleviating their financial burdens.