Abbvie Inc Stock Price, News & Analysis

AbbVie has submitted applications for upadacitinib (RINVOQ^®) to the FDA and EMA to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA) who inadequately respond to NSAIDs. Based on the Phase 3 SELECT-AXIS 2 trial, upadacitinib showed efficacy in reducing symptoms and improving physical function. Additionally, AbbVie requested label enhancements for upadacitinib in the EU for active ankylosing spondylitis (AS). The safety profile remained consistent with previously known data, with no new risks identified.

AbbVie (NYSE: ABBV) is set to report its fourth-quarter and full-year 2021 financial results on February 2, 2022, before market opening. A live webcast of the earnings call will occur at 8 a.m. CT on the same day, accessible via AbbVie's Investor Relations website. Following the event, an archived version will be available for later viewing. AbbVie focuses on delivering innovative medicines across various therapeutic areas including immunology, oncology, and neuroscience.

AbbVie (NYSE: ABBV) has received Breakthrough Therapy Designation (BTD) from the FDA for its investigational drug telisotuzumab vedotin (Teliso-V). This designation targets patients with advanced/metastatic non-small cell lung cancer (NSCLC) characterized by high c-Met overexpression and disease progression post-platinum therapy. Teliso-V aims to address the significant unmet medical needs in NSCLC treatments. Data from the ongoing Phase 2 study (LUMINOSITY) shows promising preliminary efficacy, with an overall response rate of 53.8% among patients with c-Met overexpressing tumors.

AbbVie (NYSE: ABBV) is set to participate in the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 2:45 p.m. CT. Key executives, including Robert A. Michael, Michael E. Severino, M.D., and Jeffrey R. Stewart, will present virtually. A live audio webcast will be accessible on AbbVie's Investor Relations website, with an archived session available later that day. AbbVie focuses on innovative medicines across various therapeutic areas including immunology and oncology.

On December 16, 2021, Allergan Aesthetics, part of AbbVie (NYSE: ABBV), completed its acquisition of Soliton, Inc. (NASDAQ: SOLY). This acquisition enhances Allergan's offering of non-invasive body contouring solutions by adding the RESONIC™ device, which is FDA-cleared for long-term cellulite improvement and tattoo removal. Clinical data showed that 97.6% of participants reported significant cellulite improvement post-treatment. The acquisition reflects Allergan's commitment to innovation in aesthetic treatments, addressing consumer concerns about cellulite.

AbbVie announced the FDA's approval of RINVOQ (upadacitinib) for treating adults with active psoriatic arthritis (PsA) who are unresponsive or intolerant to TNF blockers. This approval is backed by two Phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, where RINVOQ met its primary endpoint with ACR20 responses of 71% and 57% vs. placebo. It demonstrated significant improvements in joint efficacy, physical function, and fatigue. Despite its benefits, RINVOQ carries risks of serious infections and cardiovascular events, particularly in older patients with heart disease risk factors.

Allergan, part of AbbVie, announced the availability of VUITY^™ (pilocarpine HCl ophthalmic solution) 1.25%, the first FDA-approved eye drop for treating presbyopia, affecting around 128 million Americans. The innovative formulation utilizes proprietary pHast™ technology to enhance near vision while maintaining distance focus. Clinical studies demonstrated significant efficacy, with participants achieving notable improvements in visual acuity.

VUITY is now available by prescription in pharmacies across the U.S., emphasizing AbbVie's commitment to advancing eye care.

AbbVie announced promising top-line results from the Phase 3 U-EXCEED study of upadacitinib for moderate to severe Crohn's disease. At week 12, 39% of patients achieved clinical remission via CDAI, and 40% showed remission via SF/AP, significantly outperforming the placebo (21% and 14%, respectively; p<0.0001). Endoscopic response was seen in 35% of the upadacitinib group versus 4% in placebo (p<0.0001). The safety profile remains consistent with previous studies, with common adverse events predominantly mild. Full data will be presented at medical conferences soon.

AbbVie has updated the U.S. prescribing information for RINVOQ (upadacitinib) for moderate to severe rheumatoid arthritis (RA) treatment. This follows an FDA Drug Safety Communication on Sept. 1, 2021, which flagged risks like malignancy and major adverse cardiac events (MACE) associated with JAK inhibitors. The updated label now emphasizes these risks in the warnings section. RINVOQ is now indicated for patients with an inadequate response or intolerance to TNF blockers. The FDA is also reviewing supplemental applications for RINVOQ for several additional conditions.