ABBVIE INC. - ABBV STOCK NEWS

AbbVie announced positive results from Study 3111-301-001, where cariprazine (VRAYLAR) demonstrated statistically significant improvement in major depressive disorder (MDD) patients inadequately responsive to current antidepressants. The study achieved its primary endpoint based on the Montgomery-Åsberg Depression Rating Scale (MADRS), with p-value 0.0050. The FDA is reviewing AbbVie's supplemental New Drug Application (sNDA) for cariprazine's expanded use in MDD, with a decision expected by year-end. The safety profile remained consistent with previous studies, with no deaths reported and manageable adverse events.

AbbVie announced that the European Medicines Agency's CHMP has issued a positive opinion recommending the approval of upadacitinib (RINVOQ) for treating adults with moderately to severely active ulcerative colitis (UC). This recommendation is supported by data from three Phase 3 studies, showing significant clinical remission rates compared to placebo. If approved by the European Commission, this would mark the fifth indication for upadacitinib in the EU, with a decision expected in Q3 2022.

AbbVie has submitted a New Drug Application (NDA) to the FDA for ABBV-951 (foscarbidopa/foslevodopa) to treat motor fluctuations in advanced Parkinson's disease. This application is supported by a Phase 3 study showing significant improvement in "On" time without troublesome dyskinesia compared to oral carbidopa/levodopa. ABBV-951 aims to provide continuous subcutaneous delivery, enhancing symptom control. The study involved around 130 participants across the U.S. and Australia, with mostly mild adverse events reported. AbbVie plans further regulatory submissions internationally.

AbbVie will present 27 abstracts at the Digestive Disease Week (DDW) Annual Meeting from May 21-24, 2022, highlighting its leadership in gastroenterology research, especially in inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS).

Key presentations will include data from Phase 3 studies of RINVOQ (upadacitinib) for ulcerative colitis and Crohn's disease. A late-breaking presentation will focus on the effectiveness of upadacitinib in Crohn's patients who have not responded to previous biologics.

AbbVie has secured an exclusive worldwide license option for CUG252, a Treg-selective IL-2 mutein from Cugene, aimed at treating autoimmune and inflammatory diseases. The agreement requires Cugene to conduct a Phase 1a study and a Phase 1b study during the option period. AbbVie will pay an upfront fee of $48.5 million and could incur further milestone payments. This partnership underscores AbbVie's commitment to developing innovative immunology therapies, addressing unmet needs in patient care amidst the complexity of autoimmune disorders.

AbbVie will showcase 46 abstracts at the ASCO Annual Meeting and EHA Congress, focusing on six investigational and approved medicines across eight cancer types. Key presentations include a five-year update on the CLL14 trial involving venetoclax and obinutuzumab for untreated chronic lymphocytic leukemia. Investigational epcoritamab data from the EPCORE™ NHL-2 trial will also be highlighted, alongside findings on navitoclax combined with ruxolitinib for myelofibrosis. These findings underscore AbbVie's commitment to advancing cancer treatment and innovation.

Genmab A/S (Nasdaq: GMAB) announced that multiple abstracts showcasing preliminary efficacy and safety findings of epcoritamab (DuoBody-CD3xCD20) will be presented at the European Hematology Association (EHA) Annual Congress in Vienna, Austria, from June 9-12. The studies include various clinical trials, focusing on B-cell non-Hodgkin lymphoma treatments. Epcoritamab is co-developed with AbbVie (NYSE: ABBV), underscoring a commitment to deliver new treatment options for patients.

AbbVie has awarded the 2022-2023 AbbVie Immunology Scholarship to 45 students in the U.S. living with chronic immune-mediated diseases, following over 1,000 applications. This initiative, since its inception in 2016, has supported more than 300 students pursuing higher education. The scholarship aims to empower these students by alleviating financial burdens and inspiring them to overcome challenges in their academic journeys. AbbView emphasizes its commitment to transforming patients' lives and enhancing community welfare through such programs.

AbbVie announced positive topline results from the U-ENDURE Phase 3 study, showing upadacitinib's effectiveness in adult patients with moderate to severe Crohn's disease. Patients receiving upadacitinib at 15 mg and 30 mg doses achieved higher rates of clinical remission and endoscopic response at week 52 compared to placebo, with remission rates of 37% and 48%, respectively, versus 15% in placebo (p<0.0001). Safety data indicated no new risks associated with upadacitinib. These findings support AbbVie's commitment to improving treatment options for Crohn's disease.