ABBVIE INC. - ABBV STOCK NEWS

AbbVie (NYSE: ABBV) announced significant findings from the Phase 3 VIALE-A clinical study, published in the New England Journal of Medicine. The study focused on newly-diagnosed Acute Myeloid Leukemia (AML) patients, showing that the combination of venetoclax and azacitidine improved overall survival compared to azacitidine alone. Patients in the venetoclax group had a median survival of 14.7 months versus 9.6 months for the placebo group, with a 34% reduced risk of death (HR=0.66). AbbVie is seeking full FDA approval for this treatment.

AbbVie reported strong Q2 2020 results with net revenues of $10.425 billion, a 26.3% increase, despite a 5.3% decline on an operational basis due to COVID-19. Key drivers included an 8.1% revenue increase in immunology, with Humira revenues of $4.837 billion. The integration of Allergan is progressing positively, enhancing AbbVie's growth platform. Adjusted diluted EPS was $2.34, while the full-year guidance for adjusted diluted EPS is now set at $10.35 to $10.45, reflecting a 11% annualized growth from Allergan. The company also announced significant clinical advancements in its pipeline.

AbbVie (NYSE: ABBV) announced positive results from the Phase 3 ADVANCE trial for atogepant, a CGRP receptor antagonist, indicating significant reductions in mean monthly migraine days compared to placebo. The trial involved 910 patients, with all doses (10 mg, 30 mg, 60 mg) achieving statistically significant improvements. Approximately 55.6% - 60.8% of patients in treatment groups reported over 50% reduction in migraine days. AbbVie plans regulatory submissions in the US and other countries based on these findings.

AbbVie announced that upadacitinib (15 mg and 30 mg) plus topical corticosteroids met all co-primary and secondary endpoints in the Phase 3 AD Up study for treating moderate to severe atopic dermatitis. At week 16, 65% and 77% of patients on upadacitinib achieved a 75% improvement in eczema severity (EASI 75) compared to 26% on placebo. Additionally, significant reductions in itch and a higher number of topical corticosteroid-free days were noted. Safety profiles were consistent with previous studies, with no new risks identified.

AbbVie announced that upadacitinib, administered as monotherapy (15 mg and 30 mg daily), successfully met both primary and all secondary endpoints in the Phase 3 Measure Up 2 study for moderate to severe atopic dermatitis. The study demonstrated significant improvement in skin clearance and itch reduction, with 60% for 15 mg and 73% for 30 mg achieving EASI 75, compared to 13% in the placebo group. Early itch reduction was noted as well. No new safety risks were observed, and the study results indicate upadacitinib's potential to address the needs of patients suffering from this condition.

On July 9, 2020, AbbVie announced FDA approval for a supplemental Biologics License Application (sBLA) expanding BOTOX® use in pediatric patients aged 2 and older for treating spasticity due to cerebral palsy. This approval builds on previous approvals for upper and lower limb spasticity. The decision supports enhanced treatment options for children experiencing debilitating muscle stiffness, which can hinder their motor development and quality of life. BOTOX® has an established safety and efficacy profile, backed by extensive research and a Phase 3 clinical study involving over 300 pediatric patients.

AbbVie (NYSE: ABBV) is set to announce its second-quarter 2020 financial results on July 31, 2020, prior to market opening. A live webcast of the earnings conference call will take place at 8 a.m. Central time and will be available on AbbVie's Investor Relations website. An archived version will be accessible later that same day. AbbVie focuses on delivering innovative medicines across various therapeutic areas, including immunology, oncology, and neuroscience.

On June 26, 2020, AbbVie (NYSE: ABBV) and Molecular Partners announced that the FDA issued a Complete Response Letter for the Biologics License Application (BLA) of Abicipar pegol, a treatment for neovascular (wet) age-related macular degeneration (nAMD). The FDA cited an unfavorable benefit-risk ratio due to high rates of intraocular inflammation associated with the treatment. AbbVie plans to discuss next steps with the FDA to address these concerns.

AbbVie (NYSE: ABBV) announced FDA review of a supplemental New Drug Application for IMBRUVICA (ibrutinib) in combination with rituximab to treat Waldenström's macroglobulinemia (WM). This application is based on over five years of data from the Phase 3 iNNOVATE clinical trial. IMBRUVICA, the only FDA-approved treatment for WM, was initially approved in 2015 and further expanded in 2018 for combination therapy. The iNNOVATE study involved 150 patients and assessed progression-free survival rates among other outcomes. Presentations of the long-term data are planned for future medical congresses.