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 Holdings, a leader in medical imaging and therapeutics, is set to host its inaugural investor day on May 17, 2022, at 8:00 a.m. in New York City. The event, featuring President and CEO Mary Anne Heino, will cover the company’s prostate cancer and microbubble franchises, along with its overall business strategy. Attendees can expect a PYLARIFY panel discussion and Q&A sessions. In-person attendance is limited and registration will be required. A live webcast will also be available for those unable to attend, ensuring broad access to the event's insights.
Lantheus Holdings (NASDAQ: LNTH) has appointed Ms. Minnie Baylor-Henry, Esq., a prominent regulatory affairs expert, to its Board of Directors. Effective immediately, she will also serve on the Compensation and Science and Technology Committees. Following this appointment, the Board will consist of nine directors, with eight being independent. Brian Markison, Chairman of the Board, highlighted her significant industry experience as essential for the company’s strategy to enhance shareholder value and improve patient outcomes.
Lantheus reported strong financial results for Q4 and FY 2021, with worldwide revenue of $129.6 million and $425.2 million, reflecting increases of 37.6% and 25.3% year-over-year, respectively. However, the company faced a GAAP net loss of $40.2 million for Q4 and $71.3 million for the full year. Adjusted fully diluted EPS improved to $0.25 and $0.49 for Q4 and FY 2021, marking increases of 263.5% and 4.0%. The company anticipates Q1 revenue guidance of $160 million - $170 million and FY 2022 guidance of $685 million - $710 million.
Lantheus Holdings has received FDA approval for its on-site drug manufacturing facility in North Billerica, Massachusetts, designed to produce DEFINITY® (Perflutren Lipid Microsphere), a leading ultrasound enhancing agent. This 16,000 sq. ft. facility aims to enhance supply security and support future growth. The facility will aid in margin expansion as DEFINITY supply becomes integrated from this location. The company intends to ship DEFINITY from this facility immediately, marking an important step in ensuring adequate supply for patients with suboptimal echocardiograms.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that data from the OSPREY pivotal trial will be presented at the 2022 ASCO GU Meeting on February 17, 2022, in San Francisco, CA. The presentation will cover the performance of Piflufolastat F 18-PET/CT in prostate cancer patients, specifically analyzing standardized uptake value results based on PSA and Gleason scores. PYLARIFY is highlighted as a PSMA-targeted PET imaging agent for identifying recurrent and metastatic prostate cancer. This data presentation is a key opportunity to showcase Lantheus's advancements in oncology diagnostics.
Lantheus Holdings (NASDAQ: LNTH) has scheduled a conference call to announce its financial and operational results for the fourth quarter and full year of 2021. This event will take place on February 24, 2022, at 8:00 a.m. ET. Investors can join via telephone or through a live webcast on the company's website. Following the call, a replay will be accessible for 30 days. Lantheus is known for its diverse portfolio of imaging diagnostics and therapeutics, aimed at addressing serious medical conditions.
Lantheus (NASDAQ: LNTH) announced a collaboration between its subsidiary EXINI Diagnostics and the Prostate Cancer Clinical Trials Consortium (PCCTC) to enhance AI-enabled imaging biomarkers for prostate cancer. The partnership aims to integrate Lantheus' FDA-cleared AI platform into early-phase studies, improving patient selection and therapy response assessments. This initiative involves Lantheus' PSMA PET/CT and bone scintigraphy imaging technologies. Prostate cancer is the second most common cancer among men, with an estimated 268,500 new cases in 2022 in the U.S.
Lantheus Holdings (NASDAQ: LNTH) has appointed Vivian Yao as the new Chief Human Resources Officer, effective immediately. She brings over 25 years of HR experience, having previously served as Vice President of Human Resources at Jabil, overseeing over 100,000 employees. Yao will report to President and CEO Mary Anne Heino and is tasked with enhancing employee experience and talent processes. Heino expressed excitement about Yao’s expertise in fostering a culture of innovation, crucial for the company's continued growth in imaging diagnostics and therapeutics.
Lantheus Holdings announces the commercial availability of PYLARIFY AI, an FDA-cleared AI platform for quantifying PSMA PET/CT scans for prostate cancer. This innovative solution utilizes a deep learning algorithm validated on over 3,000 images to enhance the accuracy and efficiency of assessments. It integrates seamlessly into clinical workflows either via cloud or local server deployment. PYLARIFY AI aims to support the uptake of PYLARIFY in clinical practice, furthering precision oncology. The first distributor in the U.S. is Syntermed.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through Payment Status for PYLARIFY (piflufolastat F 18) effective January 1, 2022. This payment status allows Medicare to provide additional payments for PET-CT scans using PYLARIFY in hospital outpatient settings. PYLARIFY is the first FDA-approved PSMA-targeted PET imaging agent for prostate cancer, enhancing early disease detection. Prostate cancer remains a significant health issue, with nearly 250,000 cases expected in 2021 alone.