BEDFORD, Mass. - Lantheus (NASDAQ:LNTH) Holdings, Inc. (NASDAQ: LNTH), a company specializing in radiopharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has approved the use of DEFINITY (Perflutren Lipid Microsphere) for pediatric patients with suboptimal echocardiograms. DEFINITY is now authorized to help visualize the heart more clearly during ultrasound exams in this younger patient population.
This FDA decision follows the review of data from three clinical trials involving a total of 189 pediatric patients with various cardiovascular conditions. The studies demonstrated that DEFINITY, when used at doses ranging from 6 µL/kg to 20 µL/kg, successfully improved the visualization of the left ventricular chamber, aiding in the detection of wall motion abnormalities and the performance of ejection fraction determinations.
According to Dr. Jean-Claude Provost, Chief Medical Officer at Lantheus, this approval marks a significant advancement for pediatric healthcare providers. Dr. Kassa Darge from the Children's Hospital of Philadelphia also emphasized the importance of this diagnostic tool for pediatric cardiologists managing complex cardiac cases.
The clinical trials highlighted the efficacy and safety of DEFINITY in pediatric patients, with reported adverse events being mild, brief, and reversible without intervention. Lantheus underscores DEFINITY's status as the most utilized ultrasound enhancing agent in the U.S., backed by over two decades of use and extensive research.
This approval is based on a press release statement from Lantheus Holdings, Inc.
InvestingPro Insights
Following the recent FDA approval for Lantheus Holdings' DEFINITY for pediatric use, the company's financial health and stock performance provide additional context for investors. According to InvestingPro data, Lantheus (NASDAQ: LNTH) has a market capitalization of approximately $4.43 billion, reflecting a significant presence in the pharmaceutical industry. The company's P/E ratio stands at 13.45, which adjusts to a more attractive 10.02 when considering the last twelve months as of Q4 2023. This adjustment suggests that the company is potentially undervalued relative to its earnings.
Revenue growth also paints a positive picture, with an impressive 38.65% increase over the last twelve months as of Q4 2023. This robust growth is complemented by a strong gross profit margin of 63.71% for the same period, indicating efficient management and a solid business model. The company's operating income margin at 38.31% further underscores its profitability.
From an investment standpoint, InvestingPro Tips highlight that analysts have revised their earnings upwards for the upcoming period, which could signal confidence in Lantheus' future performance. Additionally, the company's cash flows are reported to sufficiently cover interest payments, providing financial stability. Lantheus operates with a moderate level of debt, and its liquid assets exceed short-term obligations, suggesting a healthy balance sheet.
Investors may also note that Lantheus does not pay a dividend to shareholders, which could be a consideration for those seeking regular income from their investments. However, the company has shown a strong return over the last month, which could be appealing for growth-oriented investors. For those interested in further insights, InvestingPro offers additional tips that can be accessed at https://www.investing.com/pro/LNTH. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription and explore more than ten additional tips that could guide your investment decisions in Lantheus Holdings.
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