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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) welcomes the Centers for Medicare & Medicaid Services' (CMS) final rule for calendar year 2025 Medicare Hospital Outpatient Prospective Payment System. The new rule, effective January 1, 2025, will 'unbundle' diagnostic radiopharmaceuticals and provide separate payments for products with daily costs exceeding $630. This change ensures continued separate payment for innovative products like PYLARIFY® after pass-through payment status expires, improving access for traditional Medicare Fee for Service patients in hospital outpatient settings.
Lantheus Holdings (NASDAQ: LNTH) has scheduled its third quarter 2024 earnings conference call and webcast for November 6, 2024, at 8:00 a.m. ET. The company will discuss its financial and operating results during this call. Participants are encouraged to register 15 minutes before the scheduled start time at the investor relations website to avoid delays. A replay will be available approximately two hours after the webcast ends and will remain accessible for at least 30 days.
Lantheus Holdings (NASDAQ: LNTH) presented results from the Phase 3 SPLASH trial of 177Lu-PNT2002, a PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC). The study met its primary endpoint, showing significant improvement in radiographic progression-free survival (rPFS) with a median of 9.5 months for 177Lu-PNT2002 vs 6.0 months for ARPI control (HR 0.71, p=0.0088). Overall Response Rate was 38.1% vs 12.0%, including 9.3% Complete Responses. Patients showed statistically significant improvement in time to reduction of health-related quality of life. Interim Overall Survival data continue to mature, with crossover-adjusted Hazard Ratios <1.00 using various methods. 177Lu-PNT2002 demonstrated a favorable safety profile compared to ARPI control.
Lantheus Holdings, Inc. (NASDAQ: LNTH), a leading radiopharmaceutical company, has appointed Julie Eastland to its Board of Directors, effective September 3, 2024. Ms. Eastland, an experienced biotechnology and financial executive, will serve as an independent director and member of the Board's Audit Committee. With her addition, the Board now comprises ten directors, eight of whom are independent.
Ms. Eastland brings extensive expertise in finance, strategic planning, operations, and transactions within the biotechnology sector. She currently serves on the boards of Dynavax Technologies and Veana Therapeutics. Her previous roles include CEO of Harpoon Therapeutics and executive positions at ReCode Therapeutics, Rainier Therapeutics, and Cascadian Therapeutics.
Lantheus Holdings (NASDAQ: LNTH), a leading radiopharmaceutical company, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. CEO Brian Markison will present on Wednesday, September 4, at 7:45 a.m. ET.
Investors and interested parties can access a live webcast of the presentation through the Investors section of Lantheus' website at www.lantheus.com. The company will make a replay of the webcast available on its website for at least 30 days following the live presentation.
This conference participation underscores Lantheus' commitment to engaging with the investment community and sharing insights into its business focused on enabling clinicians to Find, Fight and Follow disease for improved patient outcomes.
Lantheus Holdings (NASDAQ: LNTH) announced that additional clinical data from the Phase 3 Pivotal SPLASH Trial for PNT2002 in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) will be presented at the ESMO Congress 2024. The presentation, titled 'Efficacy of 177Lu-PNT2002 in PSMA-positive mCRPC following progression on an androgen-receptor pathway inhibitor (ARPI) (SPLASH)', will be delivered by Dr. Oliver Sartor from the Mayo Clinic on September 15, 2024. This presentation will include new data from the initial December 2023 readout, potentially providing important insights into the efficacy of PNT2002 for treating advanced prostate cancer.
Lantheus Holdings (NASDAQ: LNTH) reported strong Q2 2024 financial results with worldwide revenue of $394.1 million, up 22.5% year-over-year. Key highlights include:
- PYLARIFY sales reached $273.3 million, up 29.8%
- DEFINITY sales grew 10.7% to $78.1 million
- Adjusted EPS increased 16.4% to $1.80
- Cash and equivalents grew to $757.0 million
The company completed three strategic transactions to expand its innovative pipeline, including acquisitions in Alzheimer's disease and oncology. Lantheus maintains its full-year 2024 revenue guidance but updated EPS guidance due to these strategic investments.
Lantheus Holdings (NASDAQ: LNTH) has announced its upcoming second quarter 2024 earnings conference call and webcast, scheduled for July 31, 2024, at 8:00 a.m. Eastern Time. The event will provide an opportunity for stakeholders to learn about the company's financial and operating results for Q2 2024. Participants are encouraged to register online at the investor relations website, preferably fifteen minutes before the start time to avoid delays. A replay of the webcast will be available approximately two hours after completion and will remain archived on the same web page for at least 30 days.
Lantheus Holdings (NASDAQ: LNTH) has acquired Meilleur Technologies, Inc., gaining worldwide exclusive rights to NAV-4694, a Phase 3 ß amyloid PET imaging agent for Alzheimer's disease. This acquisition expands Lantheus' Alzheimer's diagnostic portfolio, complementing their existing tau-targeting agent MK-6240. The move aligns with updated NIA-AA guidelines recommending biomarkers for Alzheimer's diagnosis.
The deal involves an upfront payment, potential milestone payments, and royalties. Lantheus aims to advance NAV-4694 through pivotal trials and commercialization. With nearly 12 million Americans living with mild cognitive impairment or Alzheimer's, and projections of over 20 million by 2050, this acquisition strengthens Lantheus' position in the growing neurology market.
Lantheus Holdings announced its support for the Centers for Medicare & Medicaid Services' (CMS) proposed 2025 Medicare Hospital Outpatient Prospective Payment System (OPPS) Rule, which aims to enhance payment for specialized diagnostic radiopharmaceuticals. CMS proposes separate payments for diagnostic radiopharmaceuticals costing over $630 per day, including Lantheus' PYLARIFY, instead of bundling these costs into nuclear medicine tests. The proposed rule includes a 60-day comment period ending September 9, 2024, with the final rule to be issued in early November and effective January 1, 2025. CEO Brian Markison highlighted the importance of equitable access to diagnostic radiopharmaceuticals for better patient outcomes.
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