EU and US could reach trade deal this weekend - Reuters
NORTH CHICAGO, Ill. - AbbVie (NYSE: ABBV), a prominent player in the biotechnology industry with a market capitalization of $318 billion and robust annual revenue of $57.4 billion, has announced the receipt of accelerated approval from the U.S. Food and Drug Administration (FDA) for EMRELIS (telisotuzumab vedotin-tllv), a treatment for adult patients with advanced stages of non-squamous non-small cell lung cancer (NSCLC) exhibiting high c-Met protein overexpression. According to InvestingPro data, AbbVie maintains an impressive gross profit margin of 71%, demonstrating its operational efficiency in bringing innovative treatments to market. This approval marks a significant development for patients who have undergone prior systemic therapy and face limited options due to their condition’s poor prognosis.
EMRELIS, a c-Met-directed antibody-drug conjugate (ADC), represents the first FDA-approved treatment for this specific patient group. The approval is based on data reflecting the overall response rate and duration of response observed in clinical trials. However, continued approval may hinge on further verification and description of clinical benefits in confirmatory trials. InvestingPro analysis reveals that 9 analysts have recently revised their earnings upwards for the upcoming period, suggesting growing confidence in AbbVie’s pipeline potential. Discover more insights about AbbVie’s market position and growth prospects in the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
Approximately 85% of lung cancers fall into the NSCLC category, and despite treatment advances, lung cancer remains the top cause of cancer-related deaths globally. High c-Met protein overexpression, which occurs in about 25% of advanced EGFR wild type, non-squamous NSCLC patients, is associated with a worse prognosis. The FDA’s decision was supported by results from the Phase 2 LUMINOSITY study, which indicated a 35% overall response rate and a median duration of response of 7.2 months for patients treated with EMRELIS.
The FDA has also approved the Roche VENTANA® MET (SP44) RxDx Assay, a companion diagnostic tool for identifying patients eligible for EMRELIS treatment. AbbVie is committed to ensuring patient access to this medication, offering support programs to reduce or eliminate out-of-pocket costs for eligible patients and providing the drug at no charge to qualifying uninsured individuals.
EMRELIS is currently being evaluated in a global Phase 3 confirmatory study, TeliMET NSCLC-01, with enrollment ongoing. With an overall "GOOD" Financial Health score from InvestingPro and a consistent track record of raising dividends for 12 consecutive years, AbbVie demonstrates strong fundamentals to support its research and development initiatives. Access detailed financial metrics, 10+ additional ProTips, and comprehensive analysis through InvestingPro’s advanced research tools. This news is based on a press release statement.
In other recent news, AbbVie has reported several significant developments. The company has entered into a strategic collaboration with ADARx Pharmaceuticals to develop small interfering RNA (siRNA) therapeutics, with an upfront payment of $335 million to ADARx. This partnership aims to advance treatments in neuroscience, immunology, and oncology. On the financial front, Guggenheim Securities has raised its price target for AbbVie to $216, citing strong first-quarter sales of Skyrizi and Rinvoq, which led to an increase in the company’s full-year 2025 earnings guidance. Meanwhile, Citi has downgraded AbbVie’s stock rating from Buy to Neutral, adjusting the price target to $205, due to concerns about AbbVie’s late-stage pipeline and policy risks. Additionally, the FDA has approved RINVOQ for the treatment of giant cell arteritis, marking it as the first oral JAK inhibitor for this condition in the U.S. BMO Capital Markets has maintained an Outperform rating on AbbVie, with a price target of $215, highlighting the strong growth of Skyrizi and Rinvoq despite a decline in Humira sales. These developments reflect AbbVie’s ongoing efforts to expand its therapeutic portfolio and address market challenges.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.