Abbvie Inc Stock Price, News & Analysis

AbbVie (NYSE: ABBV) announced the acceptance of its New Drug Application (NDA) by the FDA for atogepant, an oral CGRP receptor antagonist, aimed at preventing migraine in adults. This decision is expected to lead to a regulatory decision by late Q3 2021. The NDA is backed by clinical data from nearly 2,500 participants, indicating atogepant's effectiveness in reducing migraine days significantly compared to placebo. The pivotal Phase 3 ADVANCE study demonstrated substantial results, with all treatment doses meeting primary efficacy endpoints.

AbbVie (NYSE:ABBV) announced an extension of the FDA review period for its supplemental New Drug Application (sNDA) for upadacitinib in treating adults with active psoriatic arthritis. The PDUFA action date has been pushed back by three months to late Q2 2021 due to an FDA request for further assessment of the drug's benefit-risk profile. Additionally, AbbVie is preparing a similar sNDA for upadacitinib's use in atopic dermatitis. The company remains confident about the approval process and its commitment to patient treatment options.

Allergan, an AbbVie company, submitted a New Drug Application (NDA) to the FDA for AGN-190584, a treatment for presbyopia, affecting 128 million U.S. adults. Expected FDA action is by end of 2021. AGN-190584 showed significant improvement in near vision in clinical studies without compromising distance vision. No serious adverse events were reported, with headache and conjunctival hyperemia as common non-serious side effects. This novel treatment could revolutionize care for presbyopia, offering a non-invasive option for those affected.

AbbVie announced FDA approval for HUMIRA® (adalimumab) to treat moderately to severely active ulcerative colitis in pediatric patients aged 5 and older. This marks the first subcutaneous biologic for these patients, allowing home administration. The approval stems from the Phase 3 ENVISION I study, which demonstrated that HUMIRA induced remission by Week 8 and maintained it at Week 52. This advancement aims to address the significant unmet needs in pediatric ulcerative colitis, providing a new, effective treatment option for children suffering from this chronic condition.

AbbVie has launched REFRESH® DIGITAL, a new lubricant eye drop designed to alleviate dryness and irritation from prolonged screen use, which affects over half of American adults. This product incorporates HydroCell™ technology to support tear film hydration. With Americans averaging 13 hours daily on digital devices, optometrist Dr. Selina McGee emphasizes the importance of this advancement for eye comfort. REFRESH® DIGITAL is available in multidose bottles and preservative-free vials at retail locations nationwide.

AbbVie announced that its drug, upadacitinib (45 mg daily), achieved significant results in the Phase 3 U-ACCOMPLISH study for treating moderate to severe ulcerative colitis. 33% of patients reached clinical remission by week 8, compared to 4% on placebo (p<0.001). All primary and ranked secondary endpoints were met, demonstrating effective clinical response and endoscopic improvements. Common adverse events included acne and increased blood creatine phosphokinase, but no new safety risks were observed. Full results will be shared at a future meeting.

AbbVie (NYSE: ABBV), Evolus (NASDAQ: EOLS), and Medytox have settled all litigation related to Jeuveau®, resolving a case filed by Medytox against Evolus. Under the agreement, AbbVie and Medytox release claims against Evolus and allow the commercialization of Jeuveau® in the U.S. and Nuceiva™ elsewhere. Evolus will pay milestone and royalty fees and issue stock to Medytox. This settlement follows an ITC decision from December 16, 2020, that found misappropriation of Medytox's trade secrets but does not affect ongoing legal matters with Daewoong.

AbbVie (NYSE: ABBV) will participate in the Cowen 41st Annual Health Care Conference on March 3, 2021, at 10:40 a.m. CT. Key executives including Michael Severino, Robert A. Michael, and Jeffrey R. Stewart will present virtually. A live audio webcast will be available on AbbVie's Investor Relations website, with an archived version accessible later the same day.

AbbVie focuses on delivering innovative medicines across multiple therapeutic areas, including immunology, oncology, and neuroscience.

AbbVie declared a quarterly cash dividend of $1.30 per share, payable on May 14, 2021, to stockholders of record as of April 15, 2021. Since its inception in 2013, AbbVie has increased its dividend by 225%. The company is part of the S&P Dividend Aristocrats Index, recognizing firms that have consistently raised dividends for at least 25 years. AbbVie focuses on innovative therapeutics across various areas, including immunology and oncology.