Key Takeaways AbbVie's neuroscience sales rose 20% in Q3, now making up about 18% of its topline.Higher sales of Botox Therapeutic, Qulipta, Ubrelvy and Vraylar drove the segment's double-digit gains.New PD therapy Vyalev added momentum as ABBV filed tavapadon to expand its neuroscience portfolio.Over the past few years, AbbVie’s (ABBV) neuroscience franchise has shifted from a secondary portfolio to a meaningful growth engine. The segment has consistently delivered double-digit growth, with its contributio ...

AbbVie’s third quarter results were marked by strong year-on-year revenue growth, driven primarily by continued momentum in its immunology and neuroscience portfolios. Management pointed to sales growth from Skyrizi and Rinvoq, as well as double-digit expansion in neuroscience products, as key contributors to the performance. However, despite surpassing Wall Street revenue and profit estimates, the market reacted negatively, reflecting heightened concern over a sharp drop in operating margin and the persis ...

Core Insights - AbbVie experienced a successful month in September, highlighted by a significant settlement regarding its product Rinvoq, leading to a 10% increase in share price [2][4]. Product Developments - AbbVie has a diverse portfolio of blockbuster drugs, with Rinvoq being a key product that generated over $1.3 billion in sales in 2024, accounting for 11% of total revenue [4]. - The company reached agreements with all generic drug manufacturers seeking to produce generic versions of Rinvoq, extending its exclusivity until April 2037 [3][4]. - AbbVie is advancing investigational drugs, including pivekimab sunirine (PVEK) for a rare blood cancer, with a Biologics License Application (BLA) currently pending with the FDA [5]. - Another investigational drug, tavapadon, aimed at treating Parkinson's disease, has had a New Drug Application (NDA) filed with the FDA [6]. Infrastructure Expansion - AbbVie is expanding its manufacturing and research capabilities, announcing a $70 million investment in the AbbVie Bioresearch Center in Massachusetts to enhance biologics production and research activities [8].

Core Insights - AbbVie has submitted a regulatory filing to the FDA for its investigational drug tavapadon as a once-daily oral treatment for Parkinson's disease [1][8] - The FDA filing is backed by results from three late-stage studies (TEMPO-1, TEMPO-2, TEMPO-3) showing symptomatic improvement in a broad Parkinson's disease population [2][8] - If approved, tavapadon would be AbbVie's second recent FDA clearance for Parkinson's disease, following the approval of Vyalev [3][8] AbbVie's Neuroscience Portfolio - AbbVie has developed a strong neuroscience segment, initially led by blockbuster drugs like Botox Therapeutic and Vraylar, and has expanded to include migraine treatments Qulipta and Ubrelvy, as well as Vyalev [7][10] - Sales from the neuroscience franchise now account for over 17% of AbbVie's total revenues, with a nearly 21% year-over-year increase in the first half of 2025, driven by higher sales of Botox and other products [8][9] Recent Acquisitions and Investments - AbbVie acquired Cerevel Therapeutics for approximately $8.7 billion, adding tavapadon to its pipeline [4] - The company has also entered into an agreement to acquire Gilgamesh Pharmaceuticals' lead pipeline drug for nearly $1.2 billion, which is in mid-stage development for major depressive disorder [10] - AbbVie previously completed a $1.4 billion acquisition of Aliada Therapeutics, adding an investigational antibody for Alzheimer's disease [10] Setbacks and Challenges - The acquisition of Cerevel also included emraclidine, which faced development discontinuation after failing two phase II studies in schizophrenia, leading to a $3.5 billion impairment charge [11]

Core Insights - AbbVie has commenced construction of a new active pharmaceutical ingredient (API) manufacturing plant in North Chicago, Illinois, marking a significant step in expanding its U.S. manufacturing capabilities [1][3] - The company plans to invest over $10 billion in capital in the U.S. over the next decade, which includes the establishment of multiple new manufacturing plants [2][3] - The new facility will enhance AbbVie's chemical synthesis capabilities and facilitate the domestic production of APIs for neuroscience, immunology, and oncology medicines [3][4] Investment and Job Creation - The investment in the North Chicago facility is part of a previously announced $195 million commitment, which is expected to create new jobs and expand AbbVie's existing manufacturing footprint [4] - AbbVie currently employs 28,000 people in the U.S., supporting over 6,000 American jobs across 11 manufacturing sites [4] Operational Timeline - The new API facility is expected to be fully operational and serving patients by 2027, contributing to AbbVie's long-term commitment to U.S. manufacturing [6]

Core Viewpoint - AbbVie has submitted a New Drug Application (NDA) to the FDA for tavapadon, a novel treatment for Parkinson's disease, based on positive results from the TEMPO clinical development program [1][2][6]. Clinical Development Program - The submission is supported by results from the TEMPO clinical development program, which includes two Phase 3 trials (TEMPO-1 and TEMPO-2) for early Parkinson's disease and one Phase 3 trial (TEMPO-3) for patients on levodopa experiencing motor fluctuations [2][3]. - TEMPO-1 and TEMPO-2 showed statistically significant improvement in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26 [2][4]. - TEMPO-3 demonstrated increased "on" time without dyskinesia for patients on levodopa [2][6]. Trial Details - TEMPO-1 enrolled 529 adults aged 40-80 with early Parkinson's disease, evaluating two fixed doses of tavapadon over 27 weeks [4]. - TEMPO-2 involved 304 adults with flexible doses of tavapadon, also over 27 weeks [5]. - TEMPO-3 included 507 adults on stable doses of levodopa, assessing tavapadon as adjunctive therapy [7]. Safety and Efficacy - The majority of adverse events reported in the trials were non-serious and mild to moderate in severity, with low incidence of serious adverse events (SAEs) [8]. - Common adverse reactions included nausea, headache, and dizziness for patients without levodopa, and nausea and dyskinesia for those on adjunctive therapy [8]. Market Potential - If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease treatment by providing a once-daily oral option [6]. - More than 11 million people globally are living with Parkinson's disease, indicating a significant market opportunity for effective treatments [9]. About Tavapadon - Tavapadon is an investigational selective D1/D5 receptor partial agonist studied for use both with and without levodopa [10]. - It is not yet approved by any health regulatory authority [10]. AbbVie's Commitment - AbbVie has over three decades of experience in neuroscience and is dedicated to advancing treatment options for neurological disorders [11]. - The company aims to address serious health issues and improve the lives of patients through innovative medicines [12].