ABBVIE INC. - ABBV STOCK NEWS

AbbVie (NYSE: ABBV) will participate in the Cowen 42^nd Annual Health Care Conference on March 8, 2021, presenting virtually at 11:50 a.m. Central Time. Key executives include Robert A. Michael, Michael E. Severino, M.D., and Jeffrey R. Stewart. A live audio webcast will be available on AbbVie's Investor Relations website, with an archived edition accessible later that day. AbbVie focuses on innovative medicines across various therapeutic areas, including immunology, oncology, and neuroscience, aimed at addressing serious health challenges.

AbbVie (NYSE: ABBV) has successfully completed the acquisition of Syndesi Therapeutics for an upfront payment of $130 million, with potential milestone payments up to $870 million. This strategic move enhances AbbVie's neuroscience portfolio, particularly focusing on the development of the lead molecule SDI-118, aimed at treating cognitive impairments linked to neuropsychiatric disorders and neurodegenerative diseases. SDI-118 is currently undergoing Phase 1b clinical trials, targeting synaptic efficiency to address unmet medical needs in patients.

AbbVie has announced that the FDA has extended its review of SKYRIZI (risankizumab-rzaa) for treating moderate to severe Crohn's disease by three months. This extension is to assess additional data concerning the on-body injector for this new indication. Previously, SKYRIZI was approved for treating moderate to severe plaque psoriasis and active psoriatic arthritis. This ongoing FDA review does not affect existing approved indications.

On February 28, 2022, AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for IMBRUVICA (ibrutinib) to treat pediatric patients aged one year and older with chronic graft versus host disease (cGVHD). A New Drug Application for an oral suspension formulation was also submitted, aiming to provide a more suitable dosage form for younger patients. The iMAGINE clinical trial, which included 59 participants, showed an overall response rate of 78%. If approved, it would be the first FDA-approved treatment option for pediatric cGVHD.

Allergan, a subsidiary of AbbVie (NYSE: ABBV), announced the presentation of new data on its eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting from March 3-6 in Nashville, TN. Key presentations will focus on DURYSTA® (bimatoprost intracameral implant) and XEN® Gel Stent, highlighting findings two years post-FDA approval of DURYSTA. Research includes studies on efficacy, safety, and real-world effectiveness of these treatments, aiming to enhance outcomes for glaucoma patients.

AbbVie announced promising top-line results from the U-EXCEL Phase 3 study, revealing that upadacitinib (45 mg daily) met its primary endpoints for clinical remission and endoscopic response in adults with moderate to severe Crohn's disease. At week 12, 49% of patients achieved clinical remission versus 29% on placebo (p<0.0001), and 46% achieved endoscopic response compared to 13% on placebo (p<0.0001). The safety profile was consistent with previous studies, with no new risks identified. Full results are to be presented in medical conferences and published in peer-reviewed journals.

AbbVie has submitted a supplemental New Drug Application (sNDA) for cariprazine (VRAYLAR) to the FDA for treating major depressive disorder (MDD) as an adjunct therapy with ongoing antidepressants. The submission is backed by Phase 3 studies indicating significant improvement in depression scores. Two studies, 3111-301-001 and RGH-MD-75, demonstrated substantial changes in the Montgomery-Åsberg Depression Rating Scale after treatment. Safety profiles remained consistent with previous data, supporting the potential for addressing treatment gaps for patients with MDD.

The board of directors of AbbVie declared a quarterly cash dividend of $1.41 per share, payable on May 16, 2022. Stockholders of record by April 15, 2022 will receive this dividend. Since its inception in 2013, AbbVie has increased its dividend by over 250%, making it a member of the S&P Dividend Aristocrats Index, which includes companies with at least 25 consecutive years of annual dividend increases.

Healis Therapeutics has secured ownership of a crucial botulinum toxin patent from AbbVie (NYSE: ABBV). This license transfer allows Healis to develop this treatment for Major Depressive Disorder (MDD), following successful results in eight Phase II trials. The acquisition is poised to expedite Healis' mission in the neuromuscular therapeutics space. However, it's important to note that, as of February 2022, botulinum toxin is still not FDA approved for MDD and remains under investigational use only.