ABBVIE INC. - ABBV STOCK NEWS

AbbVie (NYSE: ABBV) is set to present nearly 30 abstracts at the upcoming American Society of Hematology (ASH) Annual Meeting, scheduled for December 11-14 in Atlanta, Georgia. Key studies include the Phase 2 CAPTIVATE and Phase 3 GLOW trials, which assess treatments for chronic lymphocytic leukemia (CLL) using ibrutinib and venetoclax. Additional research will cover various hematologic cancers, focusing on venetoclax's efficacy in CLL and multiple myeloma. The findings aim to advance care standards for patients with significant unmet medical needs.

AbbVie (NYSE: ABBV) will present new data on RINVOQ®, SKYRIZI®, and HUMIRA® at the ACR Convergence 2021, held virtually from November 3-9. This includes 38 abstracts focusing on rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Notable presentations highlight long-term safety and efficacy data for RINVOQ in rheumatoid arthritis, along with efficacy data for risankizumab in psoriatic arthritis. However, use of RINVOQ and risankizumab in psoriatic arthritis is not yet FDA-approved.

Allergan, a subsidiary of AbbVie (NYSE: ABBV), announced FDA approval for VUITY (pilocarpine HCl ophthalmic solution) 1.25% to treat presbyopia, affecting 128 million Americans. This marks VUITY as the first FDA-approved eye drop for this condition, providing rapid relief within 15 minutes and lasting up to 6 hours. The approval is based on two phase 3 studies (GEMINI 1 and GEMINI 2) showing significant improvement in near vision without distance vision loss. The most common side effects are headache and eye redness.

AbbVie announced results from two Phase 3 trials of cariprazine (VRAYLAR) as an adjunctive treatment for major depressive disorder (MDD). In Study 3111-301-001, patients on 1.5 mg/day of cariprazine showed significant improvement in their MADRS scores compared to placebo (p=0.0050). However, 3.0 mg/day did not reach significance. Study 3111-302-001 did not meet its primary endpoint. Positive findings from a prior Phase 2/3 study prompted AbbVie to plan an sNDA with the FDA for expanded cariprazine use. Safety data aligned with established profiles, with common side effects including akathisia and nausea.

AbbVie (NYSE:ABBV) reported robust financial results for Q3 2021, with worldwide net revenues reaching $14.342 billion, an increase of 11.2% year-over-year. The company raised its full-year 2021 EPS guidance to between $6.29 and $6.33. AbbVie also announced a dividend increase of 8.5%, reflecting a 250% increase since inception. Key contributors included strong sales from its immunology portfolio, particularly Humira and Skyrizi. Notable approvals and submissions for new treatments further bolster its long-term growth prospects.

AbbVie announced that ABBV-951 (foslevodopa/foscarbidopa) outperformed oral levodopa/carbidopa in a Phase 3 trial for advanced Parkinson's disease. After 12 weeks, patients receiving ABBV-951 experienced an increase in "On" time without troublesome dyskinesia of 2.72 hours, compared to 0.97 hours for oral LD/CD (p=0.0083). The trial met its primary endpoint, demonstrating a significant reduction in "Off" time as well. While most adverse events were mild, discontinuation due to adverse events was notably higher in the ABBV-951 group (21.6%) versus the oral group (1.5%).

Allergan, an AbbVie company, announced it will present new analyses from Phase 3 trials of AGN-190584 (pilocarpine HCl ophthalmic solution 1.25%) at Academy 2021 from November 3-6. The treatment aims to improve near vision for those with presbyopia, a common age-related condition. Dr. Michael R. Robinson highlighted the significance of these results for practitioners. Phase 3 studies demonstrated significant improvements in near vision without compromising distance vision. ABBV submitted a New Drug Application to the FDA earlier in the year, anticipating market launch as VUITY™.

AbbVie (NYSE: ABBV) announced a positive opinion from the European Medicines Agency's CHMP recommending approval of risankizumab (SKYRIZI^®) for treating active psoriatic arthritis in adults with inadequate response to DMARDs. Supported by Phase 3 studies KEEPsAKE-1 and KEEPsAKE-2, the drug demonstrated significant efficacy at week 24. If approved, this will be risankizumab's second indication in the EU, following its 2019 approval for plaque psoriasis. The drug's safety profile remains consistent through 52 weeks of exposure, with common adverse reactions including upper respiratory infections and fatigue.

Allergan Aesthetics, part of AbbVie (NYSE: ABBV), is intensifying its commitment to breast cancer awareness through a series of initiatives under the campaign The Power of You, starting in October and continuing into 2022. Key actions include a limited edition apparel collection with GOLDSHEEP, a virtual fundraiser, a book launch highlighting breast reconstruction, and a film addressing the BRCA1 mutation. Allergan Aesthetics aims to empower women and educate them on breast health, contributing financially to various breast cancer organizations through these programs.