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AbbVie Inc. (ABBV) is a global biopharmaceutical leader driving innovation in immunology, oncology, and neuroscience therapies. This page provides real-time access to AbbVie's official press releases, regulatory milestones, and strategic developments.
Investors and industry professionals will find a curated collection of earnings reports, FDA approval updates, clinical trial results, and partnership announcements. Our comprehensive resource eliminates the need to track multiple sources, offering verified information directly from corporate communications and trusted financial publications.
Key content includes updates on AbbVie's R&D pipeline, mergers & acquisitions like the Allergan integration, patent developments, and market expansion initiatives. All materials are organized chronologically for efficient analysis of the company's trajectory.
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Allergan Aesthetics, a division of AbbVie (NYSE: ABBV), announced the acquisition of Soliton (NASDAQ: SOLY) for $22.60 per share, valuing the deal at approximately $550 million. The acquisition includes Soliton's FDA-cleared RESONIC™ device, which offers a non-invasive treatment for cellulite. This technology enhances Allergan’s body contouring portfolio, complementing its existing products like CoolSculpting®. The transaction is subject to regulatory approvals and shareholder consent.
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced an agreement to acquire Soliton (NASDAQ: SOLY) for $22.60 per share in cash, valuing the transaction at approximately $550 million. This acquisition aims to enhance Allergan's portfolio with Soliton's RESONICTM device, which has received FDA 510(k) clearance as a non-invasive cellulite treatment. The deal, approved by both companies' boards, is subject to customary closing conditions. Allergan's established market presence is expected to maximize the commercial potential of Soliton's technology.
AbbVie reported strong first-quarter results for 2021, with worldwide GAAP net revenues of $13.010 billion, up 51%. Adjusted net revenues increased 5.2% to $12.935 billion. The immunology portfolio contributed $5.744 billion. Notable products include Humira with revenues of $4.867 billion, and Skyrizi at $574 million. AbbVie anticipates multiple product approvals in 2021, raising full-year GAAP diluted EPS guidance to $6.89-$7.47 and adjusted EPS to $12.37-$12.57.
Allergan, a subsidiary of AbbVie (NYSE: ABBV), will present new data on its eye care portfolio at the 2021 ARVO Annual Virtual Meeting from May 1-7. This includes patient-reported outcomes for AGN-190584, an investigational treatment for presbyopia, for which a New Drug Application has been submitted to the FDA. Key presentations will cover the effectiveness of DURYSTA™ in lowering intraocular pressure and real-world data from the multicenter EXPAND study involving the XEN® Gel Stent. The meeting will showcase advancements in treating challenging eye conditions.
AbbVie (NYSE: ABBV) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for VENCLYXTO® (venetoclax) combined with hypomethylating agents to treat adults with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive chemotherapy. This recommendation supports AbbVie’s mission to enhance treatment options for patients facing this aggressive cancer. The final decision from the European Commission is anticipated in the first half of 2021, following promising trial results indicating improved survival rates.
AbbVie has submitted applications to the FDA and EMA for SKYRIZI® (risankizumab-rzaa) to treat adults with active psoriatic arthritis. These submissions are based on two pivotal Phase 3 trials, KEEPsAKE-1 and KEEPsAKE-2, demonstrating significant improvements in disease activity and skin clearance at week 24. SKYRIZI, an IL-23 inhibitor, aims to provide effective treatment for patients who have not responded to other therapies. The safety profile remains consistent with previous studies, showing no new risks.
AbbVie (NYSE: ABBV) will showcase new data from its neuroscience portfolio at the virtual 2021 American Academy of Neurology (AAN) Annual Meeting, occurring from April 17-22. A total of 33 abstracts will be presented, including one podium and three oral presentations, focusing on migraine, advanced Parkinson's disease, and spasticity. Highlights include pivotal Phase 3 data on atogepant for migraine prevention and the study of ABBV-951, a continuous infusion treatment for advanced Parkinson's disease. AbbVie aims to make significant impacts on neurological disorders through its innovative treatments.
AbbVie announced an extension of the FDA review period for the supplemental New Drug Application (sNDA) of upadacitinib for moderate to severe atopic dermatitis. The action date has been moved to early Q3 2021, a three-month extension. This request from the FDA was for an updated assessment of the drug's benefit-risk profile, expected due to the complexity of the review process. AbbVie remains optimistic about the application and continues to collaborate with the FDA to expedite the approval process for this important treatment option.
Allergan Aesthetics, part of AbbVie, has launched SkinMedica® Neck Correct Cream to target neck and décolleté aging. This innovative product is designed to firm, tighten, and improve the appearance of moderate to severe neck aging, featuring efficacy in clinical studies with users reporting significant satisfaction. It targets key aging concerns using a blend of peptides, antioxidants, and botanical extracts. Priced at $135, it’s available through licensed physicians and spas, supported by a digital campaign highlighting its performance. For more details, visit SkinMedica.com.
AbbVie (NYSE: ABBV) announced the publication of the 24-week results from its Phase 3 SELECT-PsA 1 trial evaluating RINVOQ™ (upadacitinib) for active psoriatic arthritis. The trial demonstrated that RINVOQ 15 mg and 30 mg significantly improved clinical outcomes, including ACR20 response and resolution of enthesitis, compared to placebo. The European Commission has approved RINVOQ for psoriatic arthritis, while the U.S. regulatory evaluation is ongoing. The safety profile was comparable to adalimumab, with upper respiratory infections as the most common adverse effect.