Abbvie Inc Stock Price, News & Analysis

AbbVie announced that the FDA has approved VRAYLAR (cariprazine) as an adjunctive treatment for major depressive disorder (MDD) in adults who experience a partial response to standard antidepressant therapy. This approval marks the fourth indication for VRAYLAR, which is the first dopamine and serotonin partial agonist approved for common forms of depression. The clinical trials showed statistically significant improvements in depression symptoms and established tolerability, enhancing treatment options for approximately 20% of U.S. adults who may suffer from MDD.

AbbVie has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS®) to the U.S. FDA, seeking approval for treating functional constipation in children and adolescents aged 6 to 17. This submission is based on positive results from a Phase 3 trial involving 330 patients, where linaclotide significantly increased spontaneous bowel movement frequency and improved stool consistency compared to placebo. Safety assessments show acceptable tolerability, with diarrhea being the most common adverse event, occurring in 4.3% of linaclotide-treated patients.

AbCellera (Nasdaq: ABCL) has initiated a strategic collaboration with AbbVie (NYSE: ABBV) targeting the development of therapeutic antibodies. This multi-year partnership aims to leverage AbCellera's innovative antibody discovery capabilities for up to five targets across various indications. AbCellera will receive research payments, clinical milestones, and royalties from product sales, indicating potential significant revenue streams. CEO Carl Hansen emphasized the collaboration's focus on solving complex antibody discovery challenges to address critical health issues.

AbbVie presented data on investigational epcoritamab at the 64th ASH Annual Meeting on December 11, 2022. Epcoritamab is being evaluated for relapsed/refractory follicular lymphoma, previously untreated follicular lymphoma, relapsed/refractory diffuse large B-cell lymphoma, and Richter's syndrome. In the EPCORE™ NHL-2 study, 95% of patients with R/R FL achieved an overall response rate, while 94% in the previously untreated FL arm also showed positive results. Epcoritamab's safety profile indicated manageable low-grade cytokine release syndrome (CRS) and common treatment-emergent adverse events.

AbbVie recently presented data from Cohort 3 of the Phase 2 REFINE study at the ASH Annual Meeting, focusing on its investigational drug navitoclax combined with ruxolitinib for JAK inhibitor-naïve myelofibrosis patients. This combination therapy showed promise in reducing bone marrow fibrosis and variant allele frequency associated with myelofibrosis. Notably, spleen volume reduction was observed in various high-risk patient subgroups, and BMF grade improvement was seen in 81% of participants. The study indicates potential disease-modifying effects, although safety assessments showed common adverse events.

AbbVie presented new data at the 64th ASH Annual Meeting on IMBRUVICA (ibrutinib) for chronic lymphocytic leukemia (CLL), focusing on the CAPTIVATE and GLOW studies. Findings showed that patients with confirmed undetectable minimal residual disease experienced high progression-free survival rates, with 95% for those continuing IMBRUVICA vs. 88% for placebo. Additionally, real-world studies indicated that IMBRUVICA treatment yielded longer time to next treatment compared to other therapies. The continued investigation of IMBRUVICA reinforces its position in CLL treatment.

AbbVie has announced a collaboration with HotSpot Therapeutics to develop the first small molecule IRF5 inhibitor for treating autoimmune diseases. The deal includes an upfront payment of $40 million and potential total payments of $295 million in milestones and royalties. This collaboration aims to enhance AbbVie's immunology pipeline, targeting conditions like systemic lupus erythematosus. HotSpot’s Smart Allostery™ platform has enabled the discovery of this novel inhibitor, marking significant progress in the treatment of poorly managed autoimmune disorders.

AbbVie (NYSE: ABBV) will present 15 abstracts showcasing its migraine treatment portfolio at the 16th European Headache Federation Congress (EHC 2022) in Vienna from December 7-10, 2022. The highlights include late-breaking data from the CaMEO-I study on neck pain and the PROGRESS Phase 3 trial results for atogepant, aimed at preventing chronic migraine in Europe. AbbVie emphasizes its commitment to addressing the challenges faced by those living with migraines, asserting its leadership in migraine research and treatment solutions.