ABBVIE INC. - ABBV STOCK NEWS

AbbVie (NYSE: ABBV) announced the commencement of its CERVINO Phase 3 trial, evaluating the efficacy, safety, and tolerability of its investigational drug, ABBV-383, for treating relapsed/refractory multiple myeloma (r/r MM).

ABBV-383 is a B-cell maturation antigen (BCMA) bispecific antibody T-cell engager with distinctive bivalent BCMA-binding domains and a low-affinity CD3 binding domain, designed for high BCMA-avidity. The trial involves a multicenter, randomized, open-label study comparing ABBV-383 monotherapy to standard available therapies (SATs) in patients who have undergone at least two prior treatment lines.

Multiple myeloma is a significant global health concern, affecting 176,000 new patients and causing 117,000 deaths in 2020. The study aims to offer a novel treatment option with a monthly dosing regimen, potentially simplifying treatment for both physicians and patients.

AbbVie announced that RINVOQ (upadacitinib) is now approved in the U.S. for treating pediatric patients aged two years and older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA), who have not responded well to TNF blockers.

This marks the first pediatric indication for RINVOQ, which is now approved for eight immune-mediated inflammatory diseases. A new weight-based oral solution, RINVOQ LQ, is also available.

The approval is based on data from adult and pediatric studies showing comparable plasma exposures and safety profiles in children and adults.

RINVOQ may cause serious side effects, including infections, cancer, and cardiovascular issues.

Allergan Aesthetics, a company under AbbVie (NYSE: ABBV), has introduced a new Refer a Friend feature for its Allē Loyalty Rewards Program. Starting June 4, 2024, Allē Members can invite friends and family to join, allowing both parties to earn up to $50 in savings on Allergan Aesthetics products and treatments such as BOTOX® Cosmetic, JUVÉDERM® Fillers, and CoolSculpting®. Members can refer up to five new users per offer period and receive $10 per referral. With over 7 million members, Allē aims to educate consumers about aesthetic treatments while offering rewards.

AbbVie (NYSE: ABBV) will participate in the Goldman Sachs 45th Annual Global Healthcare Conference on June 12, 2024. Key executives, including President and COO Robert A. Michael, CFO Scott T. Reents, CCO Jeffrey R. Stewart, and Chief Medical Officer Dr. Roopal Thakkar, will present at 9:00 a.m. Central time. Investors can access a live audio webcast through AbbVie's Investor Relations website, with an archived version available later in the day.

AbbVie received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for risankizumab (SKYRIZI®) to treat adults with moderately to severely active ulcerative colitis. This recommendation is based on two Phase 3 trials, INSPIRE and COMMAND, which showed that the treatment met the primary endpoint of clinical remission and key secondary endpoints. The induction dose is 1200 mg IV, followed by maintenance doses of 180 mg or 360 mg SC. The final decision from the European Commission is expected in Q3 2024.

The trials demonstrated that risankizumab provides long-term management beyond symptom control, including histologic-endoscopic mucosal healing. The safety profile was consistent with previous studies, with no new safety risks observed. AbbVie collaborates with Boehringer Ingelheim on risankizumab, and AbbVie leads its development and commercialization globally.

AbbVie has announced new data from its innovative antibody-drug conjugate (ADC) platform, which will be showcased across three oral presentations at the ASCO 2024 Annual Meeting. Key highlights include:

1. Phase 1 study of ABBV-400 in metastatic colorectal cancer (CRC) showing promising antitumor activity with an objective response rate (ORR) of up to 24% in heavily pre-treated patients.

2. First-in-human study of ABBV-706 in small cell lung cancer (SCLC) and high-grade neuroendocrine neoplasms (NENs), demonstrating an ORR of 43.8% overall and 60.9% in the SCLC group.

3. Phase 2 LUMINOSITY trial data for Telisotuzumab vedotin (Teliso-V) in advanced non-small cell lung cancer (NSCLC), previously treated and c-Met-overexpressing.

The ADCs target unique protein biomarkers like c-Met and SEZ6, delivering potent cancer cell death-inducing agents to tumors. Additional data will be presented on the safety and efficacy of these treatments.

AbbVie has completed its acquisition of Landos Biopharma, enhancing its portfolio with NX-13, a first-in-class oral NLRX1 agonist currently in Phase 2 trials for treating ulcerative colitis (UC) and Crohn's disease (CD). The acquisition, priced at $20.42 per share plus up to $11.14 per share upon achieving a clinical milestone, aims to offer a novel, dual-action treatment approach to inflammatory bowel disease (IBD), combining anti-inflammatory properties and epithelial repair. Landos' stock will stop trading on NASDAQ from May 24, 2024. AbbVie expressed its commitment to transforming the standard of care for IBD patients.

AbbVie announced its participation at the 2024 Digestive Disease Week (DDW) Annual Meeting, presenting 15 abstracts focused on inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis. Key presentations include data from the SEQUENCE trial comparing risankizumab (SKYRIZI) and ustekinumab (STELARA) in Crohn's disease, and findings from the INSPIRE and COMMAND Phase 3 studies on risankizumab for ulcerative colitis. The company highlighted advancements in treatment outcomes, including symptom relief, economic impacts, and long-term efficacy and safety across its gastroenterology portfolio.

AbbVie and Gilgamesh Pharmaceuticals have announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. This partnership aims to leverage AbbVie's expertise in psychiatry and Gilgamesh's innovative research platform to discover novel neuroplastogens targeting mechanisms that may provide significant clinical benefits while minimizing challenging side effects seen with first-generation compounds. The agreement includes a significant upfront payment, potential milestone fees, and royalties for Gilgamesh, showcasing AbbVie's commitment to advancing mental health treatment through innovative technologies.