Welcome to our dedicated page for Lantheus Holding news (Ticker: LNTH), a resource for investors and traders seeking the latest updates and insights on Lantheus Holding stock.
Lantheus Holdings, Inc. (NASDAQ: LNTH) is a radiopharmaceutical-focused company whose news flow centers on diagnostic imaging products, radiopharmaceutical pipeline progress and corporate developments. The company describes its purpose as enabling clinicians to "Find, Fight and Follow" disease, and its announcements frequently highlight advances in PET radiodiagnostics, oncology imaging agents and Alzheimer’s disease diagnostics.
News about Lantheus often covers regulatory milestones for its radiopharmaceutical pipeline. Recent releases include U.S. Food and Drug Administration (FDA) acceptance of a New Drug Application for a new formulation of its piflufolastat F 18 PSMA PET imaging agent, a PDUFA date for LNTH-2501 (Ga 68 edotreotide) for somatostatin receptor-positive neuroendocrine tumors, and FDA acceptance of an NDA for MK-6240, a tau-targeted PET imaging agent for Alzheimer’s disease. These updates provide insight into how the company is expanding its diagnostic portfolio in oncology and neurology.
Lantheus news also frequently addresses business development and portfolio shaping. The company has reported acquisitions of Evergreen Theragnostics and Life Molecular Imaging, adding assets such as OCTEVY and Neuraceq and expanding its capabilities across the radiopharmaceutical value chain. It has also announced the divestiture of its SPECT business to SHINE Technologies, along with licensing agreements such as an exclusive deal with GE HealthCare to develop, manufacture and commercialize PYLARIFY in Japan.
Investors and healthcare professionals following LNTH news can also expect quarterly earnings releases, stock repurchase program announcements, leadership transition updates and conference participation notices. Together, these items provide context on Lantheus’ financial performance, capital allocation, governance and strategic direction in the radiopharmaceutical and medical imaging space.
Lantheus (NASDAQ: LNTH) announced the FDA accepted its New Drug Application for MK-6240, an F18-labeled PET imaging agent targeting tau neurofibrillary tangles in patients evaluated for Alzheimer’s disease.
The NDA benefits from prior Fast Track designation and is supported by two pivotal Phase 3 trials that met co-primary endpoints for sensitivity and specificity. The FDA set a PDUFA target action date of August 13, 2026. Company leadership said MK-6240 could complement beta-amyloid PET and blood-based diagnostics if approved.
Lantheus (NASDAQ: LNTH) will host a Third Quarter 2025 earnings conference call and webcast on Thursday, November 6, 2025 at 8:00 a.m. ET to discuss financial results and provide a business update.
Participants should register online at https://investor.lantheus.com/news-events/calendar-of-events and are encouraged to register at least 15 minutes before the start to avoid delays. A replay will be posted about two hours after the webcast and archived on the same page for at least 30 days.
Lantheus Holdings (NASDAQ: LNTH) and GE HealthCare (NASDAQ: GEHC) have entered into an exclusive licensing agreement for GE HealthCare to develop, manufacture, and commercialize PYLARIFY® in Japan. The agreement focuses on prostate cancer diagnostics and companion diagnostic use.
PYLARIFY, a PET imaging agent for PSMA-positive lesions in prostate cancer patients, has already achieved success with over 500,000 scans across 48 states in the U.S. The deal includes regulatory dossiers transfer, manufacturing expertise, and technical support. GE HealthCare will leverage its network and R&D capabilities, particularly through its recently acquired Nihon Medi-Physics Co., Ltd.
Under the agreement terms, GE HealthCare will pay Lantheus an upfront license fee, development milestones, and tiered royalties based on Japanese market sales. The collaboration aims to address Japan's significant prostate cancer market, which ranks third globally in case numbers.
Lantheus Holdings (NASDAQ: LNTH), a leading radiopharmaceutical company, has announced its participation in the upcoming Morgan Stanley 23rd Annual Global Healthcare Conference. CEO Brian Markison will deliver a presentation on Tuesday, September 9, at 7:00 a.m. ET.
Investors and interested parties can access the live webcast through the Investors section of Lantheus.com. The presentation recording will remain available on the company's website for a minimum of 30 days following the live event.
Lantheus (NASDAQ: LNTH) reported Q2 2025 financial results with worldwide revenue of $378.0 million, down 4.1% year-over-year, and GAAP EPS of $1.12. The company completed two strategic acquisitions: Life Molecular Imaging, adding Neuraceq® for Alzheimer's diagnosis, and Evergreen Theragnostics, enhancing their radiopharmaceutical capabilities.
Key developments include FDA acceptance of a new NDA for piflufolastat F 18 PSMA PET imaging agent, FDA label expansion for Neuraceq, and a new $400 million stock repurchase program. PYLARIFY sales declined 8.3% to $250.6 million amid increased competition, while DEFINITY sales grew 7.5% to $83.9 million. The company revised its FY2025 guidance downward, now expecting revenue between $1.475-$1.51 billion and adjusted EPS of $5.50-$5.70.
Lantheus Holdings (NASDAQ: LNTH) announced FDA acceptance of a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent. The FDA has set a PDUFA date of March 6, 2026 for the application filed by Lantheus' affiliate, Aphelion.
The new formulation is designed to optimize manufacturing and increase batch size by approximately 50%, building on the success of PYLARIFY, Lantheus' market-leading PSMA PET imaging agent. PYLARIFY has demonstrated an 86% median true-positive rate in detecting recurrent prostate cancer. The enhanced formulation aims to maintain the same efficacy while improving patient access and operational efficiency through increased radioactive concentration.
Lantheus Holdings (NASDAQ: LNTH) has scheduled its second quarter 2025 earnings conference call and webcast for August 6, 2025, at 8:00 a.m. ET. During this event, the company will discuss its Q2 2025 financial results and provide a business update.
Participants can register for the event at investor.lantheus.com/news-events/calendar-of-events. Registration is recommended 15 minutes before the start time. A replay will be available approximately two hours after the webcast and will remain accessible for at least 30 days.
Lantheus Holdings (NASDAQ: LNTH) has completed its acquisition of Life Molecular Imaging Ltd., a subsidiary of Life Healthcare Group Holdings Ltd. The company has appointed Dr. Ludger Dinkelborg, former CEO of Life Molecular Imaging, as Head of Research and Development effective August 1, 2025.
Through this strategic acquisition, Lantheus gains Neuraceq®, a globally approved F-18 PET imaging agent for detecting beta-amyloid plaques in Alzheimer's disease evaluation. The deal strengthens Lantheus's position in Alzheimer's diagnostics with enhanced commercial infrastructure, R&D capabilities, and international presence.