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Abbvie Inc - ABBV STOCK NEWS

Welcome to our dedicated page for Abbvie news (Ticker: ABBV), a resource for investors and traders seeking the latest updates and insights on Abbvie stock.

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.

Bookmark this page for streamlined monitoring of AbbVie's operational and financial performance. Check back regularly to stay informed about developments impacting one of the pharmaceutical sector's most influential innovators.

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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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AbbVie (NYSE: ABBV) has scheduled its first-quarter 2025 financial results announcement for Friday, April 25, 2025, before market opening. The company will host a live webcast earnings conference call at 8 a.m. Central time, which will be accessible through AbbVie's Investor Relations website at investors.abbvie.com. An archived version of the session will be made available later the same day.

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AbbVie (NYSE: ABBV) announced new data presentations at the upcoming AACR Annual Meeting (April 25-30, 2025), highlighting advances in early oncology research. The company will showcase two key investigational molecules:

1. ABBV-969: A novel dual-targeted antibody-drug conjugate (ADC) targeting STEAP1/PSMA in Phase 1 trials for metastatic castration-resistant prostate cancer. The drug uses a proprietary cytotoxic topoisomerase 1 inhibitor payload.

2. ABBV-514: A novel CCR8-targeting antibody in Phase 1 trials for non-small cell lung cancer, head and neck cancer, and other solid tumors. Preclinical data shows strong monotherapy activity, including in anti-PD-1 resistant models.

Additional presentations will focus on real-world-data analyses regarding treatment resistance and biomarker identification, including studies on folate receptor alpha expression in ovarian cancers and immunotherapy response in non-small cell lung cancer.

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Allergan Aesthetics, an AbbVie company, will showcase its innovation and expertise at the Anti-Aging and Aesthetics Medicine World Congress (AMWC) in Monaco from March 27-29, 2025. The event will highlight the new AA Signature program, an innovative treatment planning approach, and celebrate 10 years of MD Codes™.

The congress features four expert-led educational events through the Allergan Medical Institute (AMI), including two major symposia: 'Design your patients' look with the NEW Signature approach' and a special session celebrating MD Codes™' decade of excellence. The program includes live injection sessions and a fireside chat with Dr. Maurício de Maio.

Additional highlights include the Science of Aging™ Symposium focusing on scientific advances in aging, and a Global Aesthetics Medical Affairs Symposium exploring the impact of aesthetic medicine on emotional well-being. The event will also feature eleven E-Poster presentations and Meet the Expert sessions at the Allergan Aesthetics booth.

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AbbVie (ABBV) announced final analysis results from the Phase 3 MIRASOL trial for ELAHERE® in treating folate receptor alpha-positive platinum-resistant ovarian cancer. After 30.5 months median follow-up, the drug showed:

  • 32% reduction in death risk compared to chemotherapy
  • Median progression-free survival of 5.59 months vs 3.98 months for chemotherapy
  • 41.9% objective response rate vs 15.9% for chemotherapy
  • Median overall survival of 16.85 months vs 13.34 months for chemotherapy

The study included 453 patients with high-grade serous epithelial PROC. Common side effects included blurred vision, keratopathy, and abdominal pain, with lower rates of serious adverse events compared to chemotherapy. ELAHERE received full FDA approval in March 2024 and European Commission approval in November 2024.

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AbbVie (NYSE: ABBV) has announced its upcoming participation in the Leerink Partners Global Healthcare Conference scheduled for Tuesday, March 11, 2025. The company's management team will engage in a fireside chat presentation starting at 7:40 a.m. Central time.

Investors and interested parties can access a live audio webcast of the presentation through AbbVie's Investor Relations website at investors.abbvie.com. For those unable to attend the live session, an archived version will be made available on the same day.

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AbbVie (NYSE: ABBV) and Gubra A/S have announced a license agreement to develop GUB014295, a potential best-in-class, long-acting amylin analog for obesity treatment. This partnership marks AbbVie's strategic entry into the obesity market.

The agreement includes a $350 million upfront payment to Gubra, with potential additional payments of up to $1.875 billion in development, commercial, and sales milestones, plus tiered royalties on global net sales. AbbVie will lead global development and commercialization activities.

GUB014295, currently in Phase 1 clinical trials, is an agonist that activates amylin and calcitonin receptors. The compound works by triggering appetite suppression signals to the brain, reducing food intake, and delaying gastric emptying. This development addresses a significant global health concern, with approximately 900 million adults affected by obesity.

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AbbVie (NYSE: ABBV) received a positive CHMP opinion recommending approval of upadacitinib (RINVOQ®) for treating adult patients with Giant Cell Arteritis (GCA). The recommendation is based on the Phase 3 SELECT-GCA trial results, which demonstrated efficacy in achieving sustained remission and other key endpoints.

If approved by the European Commission in the first half of 2025, RINVOQ would become the first and only oral advanced therapy for adults with GCA. The trial evaluated upadacitinib (15 mg, once daily) in adults aged 50 and older, comparing 7.5 mg or 15 mg doses combined with a 26-week corticosteroid taper regimen against placebo with a 52-week taper.

The safety profile during the 52-week, placebo-controlled period aligned with observations from other approved indications. RINVOQ is currently approved in the EU for multiple conditions including radiographic axial spondylarthritis, psoriatic arthritis, and Crohn's disease, though not yet for GCA.

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AbbVie (NYSE: ABBV) has announced its upcoming participation in TD Cowen's 45th Annual Health Care Conference. The event will take place on Wednesday, March 5, 2025, featuring a management fireside chat scheduled for 8:10 a.m. Central time.

Investors and interested parties can access a live audio webcast of the presentation through AbbVie's Investor Relations website at investors.abbvie.com. An archived version of the session will be made available for viewing later the same day.

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