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Thursday, Oppenheimer analysts maintained an Outperform rating on Abbott Laboratories (NYSE:ABT) shares, with a price target of $134.00, following the company’s announcement of receiving the CE Mark for its Volt PFA catheter. Abbott, a prominent player in the Healthcare Equipment & Supplies industry with a market capitalization of $226 billion, has demonstrated strong financial performance with revenues of $42 billion in the last twelve months. According to InvestingPro analysis, the company maintains a robust financial health score of GOOD, supported by strong profit margins exceeding 55%. This regulatory milestone allows Abbott to commence commercial cases in the European Union, a development that occurred ahead of the previously anticipated first half of 2025.
According to the company, the commercialization in the EU will begin with physicians who have participated in clinical studies of the Volt PFA System. Abbott plans to expand the availability of Volt across EU markets during the latter half of the year. This progress in Europe comes as Abbott anticipates approval for the Volt PFA catheter in the United States between late 2025 and early 2026. The company’s strong financial position, with a healthy current ratio of 1.67 and moderate debt levels, positions it well for this expansion. InvestingPro data reveals that Abbott has maintained dividend payments for 55 consecutive years, demonstrating remarkable financial stability.
The analyst from Oppenheimer noted the significance of the early CE Mark approval, which exceeded the company’s initial timeline projections shared during their fourth-quarter earnings call. The earlier-than-expected European approval may suggest a potential for the U.S. Food and Drug Administration (FDA) approval to align with the earlier end of the projected timeline, especially considering the recent FDA approvals of competitor PFA devices.
Abbott’s proactive approach has involved initiating commercial cases in the EU with experienced physicians, thereby demonstrating the company’s readiness to leverage clinical study results to advance its commercial strategy. The company’s intention to broaden the use of its catheter system later this year indicates a phased approach to its rollout in the European market.
In summary, the CE Mark approval not only marks a key regulatory achievement for Abbott but also potentially sets the stage for an accelerated timeline for FDA approval. The company’s strategic execution in the EU could serve as a precursor to its planned market expansion and regulatory progress in the U.S. Based on InvestingPro’s Fair Value analysis, Abbott’s stock is currently fairly valued. Investors can access detailed financial analysis, 10+ additional ProTips, and comprehensive valuation metrics through InvestingPro’s in-depth research report, available as part of the platform’s coverage of 1,400+ top US stocks.
In other recent news, Abbott Laboratories announced the CE Mark approval for its Volt PFA System, designed for atrial fibrillation treatment, marking a significant development for the company in the European Union. This approval allows Abbott to expand its commercial cases across Europe, with the system already showing a 99.1% success rate in achieving pulmonary vein isolation. In addition, Abbott received an investigational device exemption from the U.S. FDA for its Coronary Intravascular Lithotripsy System, enabling the start of the TECTONIC clinical trial to evaluate its effectiveness in treating coronary artery disease. Analysts from BTIG and TD Cowen have reiterated their Buy ratings for Abbott, with price targets set at $140 and $135, respectively. BTIG’s endorsement follows the early completion of enrollment for the Volt-AF U.S. IDE trial, while TD Cowen expressed confidence in Abbott’s compliance with the new FDA initiative for infant formula safety. Abbott has maintained a stable supply of infant formula, operating at full capacity after addressing previous challenges at its Sturgis facility. The company’s advancements in both electrophysiology and vascular technologies are aimed at enhancing patient outcomes and expanding their market presence.
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