AbbVie (ABBV) announced that the FDA has granted accelerated approval to its antibody-drug conjugate (ADC), telisotuzumab vedotin (or Teliso-V), for treating certain patients with non-small cell lung cancer (NSCLC). The drug will be marketed under the brand name Emrelis.Under this approval, Emrelis is approved to treat adult patients with locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression (OE) who have received a prior systemic therapy. This makes it the first FDA-appr ...

NEW YORK, May 15, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Cerevel Therapeutics Holdings, Inc. (NYSE: ABBV).Shareholders who purchased shares of ABBV during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/cerevel-therapeutics-holdings-inc-loss-submission-form/?id=148431&from=4 ...

I last wrote on AbbVie Inc. (NYSE: ABBV (NEOE: ABBV:CA ) and Pfizer Inc. (NYSE: PFE ) (NEOE: PFE:CA ) both back in March 2024. My last As you can tell, our core style is to provide actionable and unambiguous ideas from our independent research. If your share this investment style, check out Envision Early Retirement. It provides at least 1x in-depth articles per week on such ideas.We have helped our members not only to beat S&P 500 but also avoid heavy drawdowns despite the extreme volatilities in BOTH the ...

Company Overview - AbbVie has a strong leadership team with key executives including Jeff Stewart (EVP and Chief Commercialization Officer), Roopal Thakkar (EVP and R&D, Chief Scientific Officer), and Scott Reents (EVP and CFO) [1][2] Current Challenges - The company is experiencing some disruption due to external factors such as MFN (Most Favored Nation) policies and tariffs, which are impacting operational timelines [3][4] - There is an ongoing discussion about the level of disruption and the time it is taking to adapt to these changes, indicating that the company is actively involved in contingency planning [3][4]

AbbVie (ABBV) 2025 Conference Summary Company Overview - **Company**: AbbVie (ABBV) - **Date of Conference**: May 14, 2025 - **Key Speakers**: - Jeff Stewart, Executive Vice President, Chief Commercialization Officer - Rupl Thacker, Executive Vice President, R&D Chief Scientific Officer - Scott Rantz, Executive Vice President, Chief Financial Officer Key Points and Arguments Industry and Market Dynamics - **Disruption and Contingency Planning**: AbbVie acknowledges some disruption due to external factors but emphasizes that it is not affecting business execution. The management team is actively involved in contingency planning and assessing implications of changes in the market [4][6][9]. - **Drug Pricing Policies**: The company is taking the potential impact of new executive orders on drug pricing seriously, indicating that they are closely monitoring developments and preparing for various scenarios [6][8][9]. - **Pricing Equalization**: AbbVie believes that the concept of equalizing drug prices between the US and Europe is complex and may not be feasible due to different healthcare systems and pricing controls in Europe [10][11][12]. Financial Performance and Projections - **Revenue Guidance**: AbbVie has increased its revenue guidance for SKYRIZI and RINVOQ to a combined $31 billion by 2027, with SKYRIZI expected to generate $20 billion and RINVOQ $11 billion [55][56]. - **Immunology Market**: The immunology segment remains a significant revenue driver, with expectations of continued growth despite pricing pressures. The company anticipates low single-digit price degradation over the next five years [51][53]. Research and Development - **M&A Strategy**: AbbVie has been active in M&A, completing over 25 transactions since early 2024, focusing on filling its pipeline in neuroimmunology and oncology [31][32]. - **Obesity Market Entry**: AbbVie has entered the obesity market through a licensing deal with Gubra for an amylin compound, highlighting the potential for differentiation and long-term market opportunities [33][39]. Competitive Landscape - **Direct-to-Consumer Advertising**: AbbVie is the largest DTC advertiser in the pharmaceutical industry. The company is prepared to pivot its marketing strategies if regulations on DTC advertising are imposed [19][21][23]. - **Oral vs. Injectable Therapies**: AbbVie believes that while oral therapies are emerging, injectable products like SKYRIZI and RINVOQ will remain insulated from significant competition due to their efficacy and convenience [64]. Other Important Insights - **Tariffs and Supply Chain**: AbbVie is monitoring the potential impact of tariffs on its supply chain and is implementing mitigation strategies to ensure product availability [26][28][29]. - **Market Growth in Obesity**: The obesity market is expected to grow significantly, with AbbVie anticipating a cash pay component that will support its aesthetics business [48]. Conclusion AbbVie is strategically navigating a complex pharmaceutical landscape with a focus on maintaining growth through innovation, M&A, and effective contingency planning. The company is well-positioned to address challenges related to drug pricing, market competition, and regulatory changes while capitalizing on emerging opportunities in the obesity market and maintaining its leadership in immunology.

Core Insights - AbbVie announced the accelerated approval of EMRELIS™ (telisotuzumab vedotin-tllv) by the FDA for treating adult patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have high c-Met protein overexpression and have received prior systemic therapy [1][2][3] - Lung cancer remains the leading cause of cancer-related deaths globally, with approximately 85% classified as NSCLC [2][3] - The approval is based on the overall response rate (ORR) and duration of response (DOR) from the Phase 2 LUMINOSITY study, which showed a 35% ORR and a median DOR of 7.2 months in patients with high c-Met overexpression [2][3] Company Overview - EMRELIS is AbbVie's first internally developed solid tumor medicine and represents a significant step in their commitment to developing cancer therapies [2][3] - The company is expanding its antibody-drug conjugate (ADC) portfolio to deliver targeted therapies to patients with difficult-to-treat tumors [2][3] - AbbVie is also focused on patient access, offering support programs to reduce out-of-pocket costs for eligible patients [6][21] Industry Context - The c-Met protein is overexpressed in approximately 25% of advanced EGFR wild type, non-squamous NSCLC patients, with about half of these patients having high c-Met overexpression [2][3] - There is a critical unmet need for targeted therapies in this patient population, as they often face poor prognosis and limited treatment options [2][3] - The FDA has also approved the Roche VENTANA® MET (SP44) RxDx Assay as a companion diagnostic to identify patients eligible for EMRELIS treatment [4][3]

NEW YORK, May 13, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Cerevel Therapeutics Holdings, Inc. ("Cerevel Therapeutics Holdings, Inc." or the "Company") (NYSE: ABBV) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Cerevel Therapeutics Holdings, Inc. investors who were adversely affected by alleged securities fraud. This lawsuit is on behalf of all persons or entities that: (a) sold or otherwise disposed of the publicly-traded com ...

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Cerevel Therapeutics Holdings, Inc. regarding a class action lawsuit related to alleged misleading statements and omissions during a secondary stock offering, which may have artificially deflated the stock price prior to a merger announcement with AbbVie Inc. [1][4] Group 1: Allegations and Impact - The lawsuit claims that Cerevel's October 16, 2023 secondary stock offering documents omitted material facts about AbbVie's interest in acquiring Cerevel at a significantly higher price than the offering price of $22.81 per share [4] - Bain Capital, Cerevel's controlling shareholder, allegedly acquired shares at an artificially depressed price while possessing nonpublic information about AbbVie's acquisition interest, resulting in a windfall of over $120 million when AbbVie announced the acquisition at $45 per share [4] - Cerevel's January 18, 2024 Proxy statement is accused of misleading investors regarding the nature and timing of AbbVie's interest in the company [4] Group 2: Class Action Details - The class period for the lawsuit includes all persons or entities that sold or disposed of Cerevel's common stock from October 11, 2023, to August 1, 2024, and those who held shares as of January 8, 2024, entitled to vote on the merger [3] - Shareholders are encouraged to register for the class action by June 3, 2025, to participate in potential recovery without any cost or obligation [5] - The Gross Law Firm aims to protect investors' rights and ensure responsible business practices by seeking recovery for losses incurred due to misleading statements or omissions [6]

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth?A few weeks ago I shared a note with Seeking Alpha readers on President Trump's promise to impose tariffs - possibly as much as 25% or more - on pharmaceutical products imported into the US.The group is for both nov ...

NEW YORK, May 12, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Cerevel Therapeutics Holdings, Inc. (NYSE: ABBV).Shareholders who purchased shares of ABBV during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/cerevel-therapeutics-holdings-inc-loss-submission-form/?id=147722&from=4 ...