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, 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.
Lantheus Holdings (NASDAQ: LNTH) announced that data from the Phase 3 CONDOR study on PYLARIFY® (piflufolastat F 18) will be presented at two significant medical conferences. The first is the RSNA meeting in Chicago from November 28 to December 2, 2021, featuring a poster discussion on diagnostic performance in prostate cancer recurrence. The second is the SUO meeting in Orlando from December 1-3, 2021, also focusing on PYLARIFY’s performance post-treatment. PYLARIFY is crucial for detecting prostate cancer and its PET imaging capabilities have garnered attention for their accuracy and efficacy.
Lantheus Holdings, a leader in imaging diagnostics and therapeutics, will have its CFO, Bob Marshall, present at the 4th Annual Evercore ISI HealthCONx Conference on November 30, 2021, at 1:00 p.m. ET. Interested parties can access a live webcast through the Investors section of their website, with a replay available for 30 days post-event. The company focuses on innovative diagnostic solutions and has a portfolio that includes products like DEFINITY, PYLARIFY, and RELISTOR.
Lantheus reported third quarter 2021 worldwide revenue of $102.1 million, a 15.3% increase year-over-year. Despite this, the company faced a GAAP net loss of $13.4 million, compared to a loss of $6.4 million in Q3 2020. Adjusted fully diluted EPS rose to $0.08, up 127.4% from $0.04 the previous year. Cash provided by operating activities was $4.3 million, with free cash flow at $1.9 million. The Independent Data Monitoring Committee recommended the continuation of the ARROW Phase 2 study. The company also raised its full-year revenue guidance to $405-$410 million.
Lantheus Holdings (NASDAQ: LNTH) announces upcoming presentations at two investor conferences. Mary Anne Heino, President and CEO, and Bob Marshall, CFO, will present at the Credit Suisse 30th Annual Virtual Healthcare Conference on November 11, 2021, at 8:50 a.m. ET and at the Jefferies London Healthcare Conference on November 18, 2021, with a pre-recorded chat available at 8 a.m. GMT. Webcasts will be accessible on the company's website, and replays will be available for 30 days post-event.
Lantheus Holdings (NASDAQ: LNTH) announced a conference call scheduled for November 4, 2021, at 8:00 a.m. ET to discuss its Q3 2021 financial and operating results. Investors can access the call by dialing 1-866-498-8390 for U.S. callers or 1-678-509-7599 for international callers, using passcode 6775813. A live webcast will also be available on the company's website. The call will provide insights into Lantheus's innovative imaging diagnostics and therapeutic solutions, including products like PYLARIFY® and RELISTOR®.
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.