Abbvie Inc Stock Price, News & Analysis

NORTH CHICAGO, Ill., Nov. 8, 2021 – Allergan, part of AbbVie (NYSE: ABBV), will present new analyses of VUITY^TM (pilocarpine HCl) and DURYSTA^® (bimatoprost) at the AAO 2021 Annual Meeting (Nov. 12-15). VUITY is the first FDA-approved eye drop for presbyopia, aiding nearly 128 million U.S. adults. DURYSTA aims to reduce intraocular pressure in glaucoma patients. Key presentations include pooled safety and efficacy data and real-world studies of glaucoma treatment. This reflects AbbVie's commitment to advancing eye care.

AbbVie presented integrated data from two Phase 3 trials, KEEPsAKE 1 and KEEPsAKE 2, showing that treatment with risankizumab (SKYRIZI) significantly improved signs and symptoms of psoriatic arthritis (PsA) after 24 weeks compared to placebo. Patients receiving risankizumab achieved an ACR20 response rate of 55.5% versus 31.3% for placebo. No new safety signals were reported, with serious treatment-emergent adverse events at 3.0% for risankizumab and 4.4% for placebo. Regulatory reviews for approval in the U.S. and EU are ongoing.

Genmab A/S (GMAB) announced several abstract presentations at the 63rd Annual ASH Meeting, showcasing the efficacy of epcoritamab (DuoBody®-CD3xCD20) for treating B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia. Over 20 abstracts from Genmab and its partners, including AbbVie (ABBV) and Janssen, will be shared, highlighting clinical trial results. A virtual R&D Update and ASH Data Review is scheduled for December 14, focusing on these advancements in oncology.

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%).