Abbvie Inc Stock Price, News & Analysis

AbbVie and Genmab announced the publication of results from the dose escalation part of the Phase 1/2 EPCORE NHL-1 trial for epcoritamab, an investigational therapy targeting relapsed/refractory B-cell non-Hodgkin's lymphoma. The trial identified a recommended Phase 2 dose of 48mg with an overall response rate of 88% and a complete response rate of 38% in patients with DLBCL. Epcoritamab demonstrated a favorable safety profile, with common adverse events being primarily grade 1-2. The results underline significant interest in new treatment options for patients with hematologic malignancies.

AbbVie (NYSE: ABBV) announced the presentation of data from its migraine portfolio at the International Headache Congress 2021 from September 8-12. The company will share 23 abstracts, including clinical findings on atogepant, an investigational CGRP receptor antagonist for preventive migraine treatment. Key studies include a 40-week evaluation of atogepant's safety and efficacy, and real-world data on ubrogepant for acute migraine treatment. AbbVie aims to further advance its commitment to migraine research and improve patient outcomes.

On August 24, 2021, the European Commission approved RINVOQ (upadacitinib), a selective JAK inhibitor, for treating moderate to severe atopic dermatitis in patients aged 12 and older. The recommended doses are 15 mg or 30 mg daily for adults and 15 mg daily for adolescents. This approval follows robust Phase 3 clinical trials involving over 2,500 participants, which demonstrated a significant reduction in eczema symptoms. RINVOQ is already approved in several countries and is under review in the U.S. The treatment option aims to improve the quality of life for affected individuals.

AbbVie announced that the New England Journal of Medicine published results from the Phase 3 ADVANCE trial of atogepant for preventing migraines in adults with episodic migraine. The study showed all dose groups (10 mg, 30 mg, 60 mg) significantly reduced mean monthly migraine days compared to placebo, with reductions of 3.7, 3.9, and 4.2 days, respectively. Atogepant is under FDA review and aims to be the first oral treatment for episodic migraine prevention. The study included 910 patients and demonstrated significant efficacy across multiple endpoints.

AbbVie announced the launch of SKYRIZI^® (risankizumab-rzaa) in the U.S. as a 150 mg single-dose injection for adults with moderate to severe plaque psoriasis. This new formulation reduces the administration frequency from two 75 mg injections to one 150 mg injection every 12 weeks after two starter doses. The FDA approved this dosage change based on clinical trials showing it offers the same efficacy and safety as the previous method. This innovation aims to enhance patient experience, reducing the number of injections required annually.

AbbVie announced the publication of 24-week results from the Phase 3b Heads Up study in JAMA Dermatology, showcasing the efficacy of RINVOQ (upadacitinib) over DUPIXENT (dupilumab) in treating moderate to severe atopic dermatitis in adults. At week 16, 71% of RINVOQ patients achieved at least a 75% improvement in eczema severity versus 61% for DUPIXENT. RINVOQ also resulted in faster reductions in itch and skin clearance. Despite a consistent safety profile, serious adverse events were noted, including one treatment-related death. The study will influence clinical treatment strategies for atopic dermatitis.

AbbVie reported strong Q2 2021 results with worldwide net revenues of $13.959 billion, a year-over-year increase of 33.9%. The immunology portfolio contributed $6.120 billion, while Skyrizi and Rinvoq showed significant growth. Adjusted diluted EPS rose to $3.11. AbbVie is raising its full-year EPS guidance to $12.57-$12.62. Recent developments include positive EMA recommendations for Rinvoq and successful Phase 3 trials for both Rinvoq and Skyrizi in various indications. The company also announced a collaboration extension with Calico Life Sciences, committing an additional $500 million.

The FDA has approved a label expansion for BOTOX^®, a product by AbbVie (NYSE: ABBV), allowing treatment of eight additional muscles in adults suffering from upper limb spasticity. This includes muscles in the elbow, forearm, and hand, enhancing therapy options for patients affected by conditions like stroke and multiple sclerosis. The new label also permits ultrasound guidance for muscle localization. While BOTOX^® has shown effectiveness in reducing muscle stiffness, it does not improve functional abilities in cases with fixed contractures.

AbbVie and Calico Life Sciences have extended their collaboration, initially established in 2014, to develop therapies for age-related diseases including neurodegeneration and cancer. The partnership, now set to continue until 2025, allows Calico to handle early research while AbbVie offers support for clinical development. Both companies will invest an additional $500 million each into the collaboration. To date, the partnership has led to over 20 early-stage programs related to immuno-oncology and neurodegeneration, and three targets have progressed to clinical trials.