ABBVIE INC. - ABBV STOCK NEWS

AbbVie announced that upadacitinib successfully met its primary and secondary endpoints in a Phase 3 study for ulcerative colitis. At week 52, clinical remission rates for 15 mg and 30 mg doses were 42% and 52%, respectively, compared to 12% for placebo (p<0.001). Additionally, significant improvements were noted in endoscopic measures and corticosteroid-free remission. The safety profile remained consistent with prior studies, with no new risks identified. Positive results have potential implications for treatment options in moderate to severe ulcerative colitis.

AbbVie announced that new data on upadacitinib for ulcerative colitis and risankizumab for Crohn's disease will be presented at the 16th Congress of ECCO on July 2-3 and July 8-10. The company will share nine abstracts, including five oral presentations, focusing on inflammatory bowel diseases (IBD). Key findings from pivotal Phase 3 studies for both drugs will be highlighted, showcasing efficacy, safety, and patient-reported outcomes. AbbVie aims to enhance understanding of patient preferences and improve standards of care in gastrointestinal diseases.

AbbVie announced that the U.S. FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for RINVOQ® (upadacitinib) targeting psoriatic arthritis and ankylosing spondylitis due to ongoing reviews related to a post-marketing study of a competitor's drug. No formal regulatory action has been taken yet. Despite this setback, AbbVie remains committed to collaborating with the FDA to deliver RINVOQ to patients.

AbbVie announced that the European Medicines Agency's CHMP has issued a positive opinion for RINVOQ^® (upadacitinib) to treat moderate to severe atopic dermatitis in adults and adolescents. The recommendation is based on data from three Phase 3 studies involving over 2,500 patients, showing significant improvements in skin clearance and itch reduction compared to placebo. The approval would mark RINVOQ as the first JAK inhibitor in the EU for this indication. If approved by the European Commission, RINVOQ will expand its indications, enhancing AbbVie's portfolio in dermatology.

AbbVie (NYSE: ABBV) has announced the acquisition of TeneoOne and its lead asset TNB-383B, a promising immunotherapeutic targeting relapsed or refractory multiple myeloma. This move comes after positive interim results from a Phase 1 study, which reported a 79% objective response rate and a 63% very good partial response rate. The recommended Phase 2 dosing aims for less frequent administration, enhancing patient convenience. The acquisition awaits customary closing conditions, including antitrust clearance.

AbbVie Inc. (NYSE: ABBV) has declared a quarterly cash dividend of $1.30 per share, payable on August 16, 2021, to stockholders of record by July 15, 2021. This dividend reflects AbbVie's strong performance, having increased its dividend by 225% since its founding in 2013. AbbVie is part of the S&P Dividend Aristocrats Index, recognizing companies that have increased dividends annually for over 25 years.

AbbVie announced promising results from the Phase 3 GLOW study evaluating the combination of IMBRUVICA® (ibrutinib) and VENCLEXTA®/VENCLYXTO® (venetoclax) versus chlorambucil plus obinutuzumab in first-line treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study achieved its primary endpoint, showing a 78% reduction in disease progression risk with I+V. Secondary endpoints indicated higher rates of undetectable minimal residual disease and better complete response rates. The safety profile was consistent with previous treatments, indicating I+V's potential as a new standard therapy.

AbbVie (NYSE: ABBV) reported results from a four-year follow-up of the Phase 3 CLL14 trial, demonstrating that patients with chronic lymphocytic leukemia (CLL) treated with the VENCLYXTO/VENCLEXTA and obinutuzumab combination had significantly improved progression-free survival (PFS) and higher undetectable minimal residual disease (MRD) rates compared to those receiving standard chemoimmunotherapy. The PFS rate at four years for the combination was 74%, while it was 35.4% for the standard treatment. No new safety concerns were reported, affirming the treatment’s effectiveness.

Allergan Aesthetics, part of AbbVie (NYSE: ABBV), is launching a new campaign titled 'See Yourself' for BOTOX^® Cosmetic. This initiative highlights the personal stories of diverse patients, promoting transparency and a judgment-free dialogue about aesthetic treatment. The campaign aims to connect with consumers as interest in aesthetic treatments rises post-pandemic. Directed by acclaimed documentarian Errol Morris, the documentary shorts feature real patient experiences. The campaign reflects BOTOX^® Cosmetic's commitment to authenticity and inclusivity in personal aesthetic choices.