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Lantheus Holdings, Inc. (NASDAQ: LNTH) is a leading radiopharmaceutical-focused company, dedicated to the development, manufacture, and commercialization of innovative diagnostic imaging agents and products. Headquartered in North Billerica, Massachusetts, and with additional offices in Puerto Rico and Canada, Lantheus has been a pivotal player in the medical imaging industry for over 65 years.
The company's primary subsidiary, Lantheus Medical Imaging, Inc. (LMI), specializes in diagnostic imaging solutions primarily for cardiovascular diseases. Key products include the echocardiography contrast agent DEFINITY® Vial, the technetium-based generator TechneLite®, and the inhaled radiopharmaceutical imaging agent Xenon Xe 133 Gas for lung imaging.
Lantheus is organized into three main business units: Precision Diagnostics, Radiopharmaceutical Oncology, and Strategic Partnerships and Other Revenue. Precision Diagnostics focuses on products that assist healthcare professionals in detecting and monitoring diseases, particularly in cardiology. Radiopharmaceutical Oncology offers diagnostics and therapeutic solutions that help healthcare providers manage cancer. Through its Strategic Partnerships, Lantheus collaborates to advance precision medicine using biomarkers and digital solutions.
Recent achievements include strategic transactions to enhance their pipeline for neuroendocrine tumors and prostate cancer. Lantheus has partnered with Perspective Therapeutics, which has developed a best-in-class alpha therapy platform, enabling Lantheus to expand its pipeline into promising alpha therapies.
Financially, Lantheus has shown robust performance. The company reported record revenues of $1.3 billion for the full year 2023, marking a 38.6% increase from 2022. This growth was driven by the successful commercialization of innovative products and strategic acquisitions.
In the Radiopharmaceutical Oncology space, the company’s Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate has been accepted by the FDA. This product is intended for treating somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Lantheus continues to drive innovation and growth through its robust pipeline and strategic collaborations. Recent leadership changes have positioned the company for its next phase of growth, with Brian Markison taking over as CEO from March 2024, following the successful tenure of Mary Anne Heino.
For ongoing updates and more information, visit their website at www.lantheus.com.
Lantheus Holdings (NASDAQ: LNTH) announced that its FDA-approved imaging agent, PYLARIFY (piflufolastat F18), has been included in the updated NCCN Guidelines for prostate cancer. This milestone recognizes PYLARIFY’s role in detecting PSMA-positive lesions in men with suspected metastasis or recurrence. Prostate cancer significantly affects the male population, with nearly 250,000 new cases expected in 2021. The inclusion in the NCCN Guidelines is anticipated to enhance awareness and utilization of PYLARIFY in clinical settings.
Lantheus and RefleXion Medical have partnered to develop and commercialize a system for real-time therapeutic guidance in prostate cancer treatment using piflufolastat F 18, a PSMA-targeted PET imaging agent. This collaboration aims to enhance the use of biology-guided radiotherapy (BgRT) via the RefleXion X1 platform, allowing precise radiation delivery to tumor sites. The agreement involves shared responsibilities and potential financial upside from this innovative approach, which could significantly impact treatment outcomes for prostate cancer patients.
Lantheus Holdings (NASDAQ: LNTH) announced promising results from the OSPREY trial regarding piflufolastat F 18, a PSMA-targeted PET imaging agent for high-risk prostate cancer. Data presented at the 2021 AUA Meeting showed that 26.9% of participants had detectable lymph node or distant metastases before definitive therapy. Furthermore, the imaging led to a change in management plans for 43.6% of patients, impacting surgical and radiation therapy recommendations. The trial demonstrated 95-98% specificity but lower sensitivity (28-39%). Overall, piflufolastat F 18 presents significant potential to influence treatment decisions.
Lantheus (NASDAQ: LNTH) has announced that Mary Anne Heino, President and CEO, and Bob Marshall, CFO and Treasurer, will present at upcoming investor conferences. The presentations will take place at the Wells Fargo 2021 Virtual Healthcare Conference on September 9, 2021, and at the Baird 2021 Global Healthcare Conference on September 15, 2021. Investors can access a live webcast of these presentations via Lantheus's website, with replays available for 30 days post-event.
Lantheus Holdings announced that its subsidiary, EXINI Diagnostics AB, received FDA 510(k) clearance for its digital application, aPROMISE™, designed for prostate cancer imaging. This AI-based software enhances efficiency and consistency in PSMA PET/CT assessments, utilizing deep learning algorithms trained on over 3,000 images. The application is intended for healthcare professionals to improve the quantification and reporting of prostate cancer lesions. This follows the recent FDA approval of PYLARIFY®, a PSMA-targeted PET imaging agent, enhancing Lantheus's prostate cancer diagnostic capabilities.
Lantheus Holdings, Inc. (LNTH) reported Q2 2021 revenue of $101.1 million, marking a 53.1% increase from Q2 2020. However, the company posted a GAAP net loss of $26.7 million, compared to $7.0 million in the prior year. Adjusted EPS slightly rose to $0.11 from $0.10. Free Cash Flow jumped to $23.2 million, an increase of approximately $27.6 million year-over-year. The FDA approved PYLARIFY, enhancing their product portfolio. Revised guidance for FY 2021 estimates revenue between $395 million and $402 million.
Lantheus Holdings, Inc. (NASDAQ: LNTH) will host a conference call and webcast on July 28, 2021, at 8:00 a.m. ET to discuss its Q2 2021 financial and operational results. Investors can join the call by dialing U.S. 1-866-498-8390 or international 1-678-509-7599, using passcode 6149638. The live webcast will be accessible on the company's website, with a replay available after the call and archived for 30 days. Lantheus specializes in innovative imaging diagnostics and therapeutics, offering a broad product portfolio, including DEFINITY®, PYLARIFY®, and RELISTOR®.
Lantheus Holdings (NASDAQ: LNTH) announced data from the CONDOR pivotal trial on piflufolastat F 18 (18F-DCFPyL), presented at the Virtual Society of Nuclear Medicine and Molecular Imaging meeting. Dr. Steven Rowe from Johns Hopkins University delivered an oral presentation on June 15, 2021, analyzing disease detection rates and positive predictive values (PPV) in men with biochemically recurrent prostate cancer. The trial revealed high PPV and median detection rates for various anatomic regions, validating PYLARIFY's efficacy in detecting metastatic lesions.
Lantheus has received FDA approval for PYLARIFY, the first PSMA-targeted PET imaging agent for prostate cancer, marking a major advancement in oncology diagnostics. The agent enhances detection of suspected metastasis and recurrence, enabling timely treatment decisions. PYLARIFY is anticipated to be available across the U.S. by year-end following its immediate rollout in select regions. The approval is supported by pivotal studies showing high specificity and localization rates, making PYLARIFY a vital tool for managing prostate cancer.
Lantheus Holdings (NASDAQ: LNTH) announced a poster presentation of data from its Phase 3 CONDOR study at the ASCO Virtual Meeting from June 4-8, 2021. The session will focus on PSMA-targeted imaging in patients with biochemically recurrent prostate cancer, highlighting the correct localization rate and positive predictive value.
Presenter Frederic Pouliot, M.D., Ph.D., from CHU de Québec-Université Laval will showcase abstract No. 5023. Lantheus is a leader in imaging diagnostics and therapeutics, providing a broad portfolio aimed at serious medical conditions.
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