Abbvie (ABBV) Stock News

AbbVie announced positive Phase 3 TEMPLE study results comparing atogepant (QULIPTA/AQUIPTA) to topiramate for migraine prevention. The study demonstrated superior safety and efficacy of atogepant, with significantly fewer treatment discontinuations due to adverse events (12.1% vs 29.6%). Notably, 64.1% of atogepant patients achieved ≥50% reduction in monthly migraine days compared to 39.3% for topiramate. The study met all primary and secondary endpoints, validating CGRP inhibitors as first-line preventive treatment. Atogepant, approved in 60 countries, maintains its established safety profile and offers a promising solution for the 14% of global population affected by migraine, addressing the current gaps in preventive treatment where over 50% of patients still qualify for additional preventive therapy.

AbbVie (ABBV) announced that its Phase 3 VERONA trial, testing venetoclax combined with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS), failed to achieve its primary endpoint of overall survival. The trial showed a hazard ratio of 0.908 with a stratified log-rank p-value of 0.3772, indicating statistical insignificance. While no new safety concerns emerged during the trial, this setback represents a missed opportunity in expanding venetoclax's treatment applications. The company plans to present detailed results at future medical conferences or in publications. Importantly, AbbVie emphasized that these results do not affect venetoclax's currently approved indications.

AbbVie (ABBV) received FDA approval for an expanded indication of MAVYRET, making it the first and only treatment for acute Hepatitis C Virus (HCV). The oral pangenotypic treatment demonstrates a 96% cure rate in just eight weeks for both adult and pediatric patients (3+ years) with acute or chronic HCV. This breakthrough therapy can now be administered immediately upon diagnosis, addressing a critical healthcare need. The approval is supported by Phase 3 study results showing high efficacy with mild to moderate side effects. This development is particularly significant as untreated HCV could lead to severe liver complications, with the US expected to face $120 billion in related medical costs through 2035. The expansion aligns with global clinical guidelines and public health goals to eliminate HCV by 2030, though most high-income countries, including the US, are currently not on track to meet this target until after 2050.

AbbVie (ABBV) has launched the second annual AbbVie Migraine Career Catalyst Award contest, offering $2,500 each to 20 winners to support their professional development goals. The contest, running until September 2, 2025, aims to help people with migraine pursue career advancement despite the condition's workplace challenges. Migraine affects up to 90% of sufferers' work productivity, with most productivity loss occurring while working through symptoms. The initiative builds on last year's success, where 20 winners used funds for creating migraine-friendly workspaces, attending conferences, and pursuing certifications. AbbVie, which offers three approved migraine treatments, demonstrates its commitment to supporting the migraine community beyond medical solutions. Winners will be announced around November 14, 2025, and entries can be submitted via essay, video, or audio format at migrainecareercatalyst.com.

AbbVie (ABBV) has announced its participation in the upcoming Goldman Sachs 46th Annual Global Healthcare Conference, scheduled for Tuesday, June 10, 2025. The company's management team will engage in a fireside chat presentation at 10:20 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.

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.

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.

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.

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.