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AbbVie (ABBV) Stock News, Apr-May 2025

ABBV NYSE

AbbVie Inc. reports pharmaceutical developments across immunology, neuroscience, oncology and Allergan Aesthetics. Recurring updates include financial results by product portfolio, clinical and real-world data for therapies such as SKYRIZI and RINVOQ, FDA regulatory submissions and response letters, and medical-conference presentations in inflammatory bowel disease and other immune-mediated conditions.

Company news also covers pipeline spending, acquired in-process research and development, manufacturing capacity for medicines in core therapeutic areas, and investor conference appearances. AbbVie’s product references commonly include SKYRIZI, RINVOQ, Botox Therapeutic, Vraylar, Ubrelvy, Qulipta, Venclexta, Imbruvica and Elahere.

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AbbVie has announced a multi-year partnership with the Chicago Cubs called 'Striking Out Cancer' to support cancer patients and advocacy. Starting May 2025, AbbVie will donate $233 for every Cubs pitcher strikeout at home games during the 2025 regular season, with the amount symbolizing the 233 Americans diagnosed with cancer hourly. The donations will go to Cubs Charities supporting non-profit cancer organizations, including Conquer Cancer, the ASCO Foundation. This initiative aligns with AbbVie's mission as a biopharmaceutical company developing therapies for various conditions, including leukemias, lymphomas, lung and gynecological cancers.
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AbbVie (ABBV) will present significant new data from its oncology portfolio at ASCO 2025 (May 30-June 3). Key highlights include results from three novel antibody-drug conjugates (ADCs): telisotuzumab adizutecan (Temab-A) showed 63% objective response rate in pre-treated EGFR-mutated NSCLC patients, with 54% of responders having ≥6 months duration of response. ABBV-706 demonstrated 31.3% ORR in high-grade neuroendocrine neoplasms with 5.6 months median duration of response. Pivekimab sunirine (PVEK) achieved 70% composite complete response rate in untreated BPDCN patients and 14% in relapsed/refractory cases. The data showcases AbbVie's progress in developing targeted therapies for difficult-to-treat solid tumors and blood cancers, particularly through their ADC platform.
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The FDA has granted accelerated approval to AbbVie's EMRELIS™ (telisotuzumab vedotin-tllv) for treating adult patients with advanced non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received prior therapy. EMRELIS, an antibody-drug conjugate (ADC), is the first and only treatment approved for this specific patient population. The approval is based on the Phase 2 LUMINOSITY study results, which showed a 35% Overall Response Rate and a median Duration of Response of 7.2 months. The c-Met protein is overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients, with about half having high c-Met overexpression. The FDA also approved the Roche VENTANA® MET (SP44) RxDx Assay as a companion diagnostic.
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AbbVie (ABBV) and ADARx Pharmaceuticals have announced a strategic collaboration and license option agreement to develop next-generation small interfering RNA (siRNA) therapeutics across neuroscience, immunology, and oncology. ADARx will receive a $335 million upfront payment and could earn several billion dollars in additional contingent payments, option fees, milestones, and tiered royalties.

The partnership combines AbbVie's expertise in biotherapeutic drug development and commercialization with ADARx's proprietary RNA technology. The collaboration focuses on developing siRNA therapeutics, which regulate gene expression by targeting messenger RNA to prevent disease-causing protein production. ADARx's technology enables sustained and precise mRNA silencing, while AbbVie contributes its expertise in antibody engineering and drug delivery approaches.

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AbbVie (NYSE: ABBV) has announced its participation in the upcoming Bank of America Securities Healthcare Conference scheduled for Wednesday, May 14, 2025. The company's management will engage in a fireside chat session at 12:00 p.m. Central time. Investors and interested parties can access the live audio webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived version of the presentation will be made available on the same day for those unable to attend the live session.

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BOTOX® Cosmetic (ABBV) has announced the continuation of 'The Confidence Project,' aimed at empowering women entrepreneurs. The program will provide 250 entrepreneurs with access to resources through a partnership with Hello Alice, including a "Boostcamp" program offering skill-building, mentorship, and networking opportunities. Additionally, 20 grants worth $20,000 each will be awarded to selected participants after completing the program.

Since 2023, BOTOX® Cosmetic has provided $1 million in grant funding across more than 40 founders. The company pledges to empower 50,000 entrepreneurs by 2030. Applications for this year's program are open from May 1 through May 9, 2025. The 250 selected participants will be announced in July, with the 20 grant recipients revealed in October 2025.

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AbbVie's RINVOQ (upadacitinib) has received FDA approval as the first oral JAK inhibitor for treating giant cell arteritis (GCA) in adults. This marks RINVOQ's ninth approved indication in the U.S., following recent European Commission authorization.

The approval is based on the Phase 3 SELECT-GCA trial results, where 46.4% of patients using RINVOQ 15mg with a 26-week steroid taper achieved sustained remission, compared to 29% in the placebo group. The drug's safety profile remained consistent with previous indications.

GCA is an autoimmune disease affecting cranial arteries, primarily impacting Caucasian women over 50. If untreated, it can lead to severe outcomes including blindness and stroke. RINVOQ offers an alternative to traditional steroid treatment, though it may cause serious side effects including infections, blood clots, and increased risk of major cardiovascular events in certain patients.

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AbbVie (ABBV) reported strong Q1 2025 financial results with worldwide net revenues of $13.343 billion, up 8.4% on a reported basis. The company's immunology portfolio led growth with revenues of $6.264 billion (+16.6%), driven by Skyrizi ($3.425 billion, +70.5%) and Rinvoq ($1.718 billion, +57.2%). Neuroscience portfolio revenues increased 16.1% to $2.282 billion.

Q1 diluted EPS was $0.72 on a GAAP basis (-6.5%) and adjusted diluted EPS was $2.46 (+6.5%). The company raised its 2025 adjusted diluted EPS guidance from $11.99-$12.19 to $12.09-$12.29. Notable developments include FDA approval of Emblaveo for complicated intra-abdominal infections and entrance into the obesity treatment field through a partnership with Gubra.

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AbbVie (NYSE: ABBV) has submitted a Biologics License Application (BLA) to the FDA for TrenibotulinumtoxinE (TrenibotE), a first-in-class botulinum neurotoxin for treating moderate to severe glabellar lines. The key differentiator of TrenibotE is its rapid onset of action within 8 hours and shorter duration of 2-3 weeks.

The submission is backed by clinical data from over 2,100 patients across multiple Phase 3 studies. All primary and secondary endpoints were met, with treatment-emergent adverse events similar to placebo. If approved, TrenibotE will be the first serotype E neurotoxin available, offering patients a shorter-duration alternative to traditional treatments.

The product aims to address patient concerns about 'fear of looking unnatural' by providing a shorter-term trial option before committing to longer-lasting treatments like BOTOX® Cosmetic.

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AbbVie (NYSE: ABBV) has received European Commission approval for RINVOQ® (upadacitinib) to treat adult patients with giant cell arteritis (GCA). This marks RINVOQ's eighth approved indication in the EU.

Key highlights from the Phase 3 SELECT-GCA trial:

  • 46.4% of patients using RINVOQ 15mg achieved sustained remission at week 52, compared to 29.0% in the placebo group
  • Disease flares were reduced to 34.3% in the RINVOQ group versus 55.6% in placebo
  • Lower cumulative steroid exposure was achieved (1615mg vs 2882mg median)
  • 37.1% of RINVOQ patients achieved sustained complete remission versus 16.1% in placebo

The safety profile remained consistent with previously approved indications, with comparable rates of serious adverse events between RINVOQ and placebo groups. RINVOQ is the first and only oral JAK inhibitor approved in the EU for GCA treatment.

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FAQ

What is the current stock price of AbbVie (ABBV)?

AbbVie (ABBV) last closed at $294.89.

What is the market cap of AbbVie (ABBV)?

The market cap of AbbVie (ABBV) is approximately $521.1B.