Abbvie Inc - ABBV STOCK NEWS

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.

AbbVie announced that the FDA has approved RINVOQ (upadacitinib) for treating adults with active ankylosing spondylitis (AS) who inadequately responded to TNF blockers. In pivotal trials, 51% and 44.5% of patients achieved ASAS40 response at 14 weeks with RINVOQ, compared to 26% and 18.2% with placebo. This approval marks RINVOQ's fifth indication for chronic immune-mediated diseases and provides patients lacking effective TNF blocker treatment an additional oral option. The company remains committed to advancing treatment standards for rheumatic diseases.

AbbVie reported a first-quarter diluted EPS of $2.51, up 26.1% year-over-year, with an adjusted diluted EPS of $3.16, a 9.3% increase. Total net revenues reached $13.538 billion, a 4.1% rise. The immunology portfolio generated $6.141 billion, representing a 6.9% growth. Humira sales dropped 2.7%, reflecting biosimilar competition. The company updated its 2022 adjusted diluted EPS guidance to $13.92 - $14.12, accounting for an $0.08 unfavorable impact from acquired IPR&D. Overall, AbbVie emphasized strong performance across its growth drivers.