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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 the filing of a Drug Master File (DMF) with the FDA for NM-01, a PD-L1 imaging biomarker aimed at enhancing immuno-oncology clinical trials beginning in 2021. NM-01 is a proprietary radiopharmaceutical that detects PD-L1 expression in tumors, potentially improving patient evaluation for I/O therapies. The checkpoint inhibitor market, projected to grow from $25B in 2019 to $68B by 2026, highlights the relevance of this innovation. Lantheus licensed NM-01 from NanoMab Technology Limited and plans to support its use in clinical research.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that the FDA has accepted the New Drug Application (NDA) for PyL™, a PSMA-targeted PET imaging agent for prostate cancer, granting it Priority Review. The PDUFA action date is set for May 28, 2021. The NDA is supported by data from pivotal studies OSPREY and CONDOR, showing significant improvements in diagnostic performance. Approximately 3,500 subjects have received PyL, which exhibits a favorable safety profile. The company aims to address the unmet need for reliable imaging in prostate cancer management.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced a strategic collaboration with POINT Biopharma, Inc. to advance cancer precision medicine. They will utilize Lantheus’ investigational PSMA-targeted PET imaging agent, PyL, in POINT's Phase 3 trial for metastatic castration-resistant prostate cancer (mCRPC). This partnership aims to enhance patient selection for therapy with POINT’s radioligand, 177Lu-PNT2002. Progenics Pharmaceuticals, a Lantheus subsidiary, will supply PyL at a predetermined price, underscoring the potential of combining diagnostics with therapy in cancer treatment.
Lantheus Holdings (NASDAQ: LNTH) announced a stock purchase agreement to sell its Puerto Rico radiopharmacy and PET manufacturing facility to PharmaLogic Holdings Corp for $18 million. This deal includes a long-term supply agreement, ensuring Lantheus continues supplying its nuclear medicine products in Puerto Rico. The transaction aims to streamline Lantheus' distribution model in the region and reinvest proceeds into its core businesses and product pipeline. The closing is expected in early Q1 2021, pending customary conditions.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that CFO Bob Marshall will present at the 2020 Evercore ISI HealthCONx Conference on December 1 at 3:30 p.m. ET. The event will be accessible via a live webcast on the Company’s website, with a replay available for 30 days post-presentation. Lantheus is a leader in diagnostic and therapeutic agents, offering products like DEFINITY®, TechneLite®, AZEDRA®, and RELISTOR®. The Company is headquartered in North Billerica, Massachusetts, with additional offices across North America and Europe.
Lantheus Holdings, Inc. (NASDAQ: LNTH) has received FDA approval for its new product, DEFINITY Room Temperature (RT), a room-temperature stable formulation of the existing DEFINITY echocardiography agent. This innovation enhances portability for healthcare providers and addresses a growing need in imaging services. DEFINITY RT, activated using the VIALMIX RFID device, is expected to broaden its clinical use. The composition patent for DEFINITY RT expires in 2035, allowing for significant market presence. Lantheus aims to leverage its microbubble franchise for improved cardiac imaging.
Lantheus Holdings (NASDAQ: LNTH) announced FDA 510(k) clearance for its AI-enabled automated bone scan index (aBSI) on GE Healthcare's Xeleris platform. This approval is pivotal for enhancing diagnostic capabilities in managing advanced prostate cancer. The global licensing agreement allows GE Healthcare to integrate aBSI into its platform, with Lantheus receiving tiered licensing fees. The aBSI product, recognized for its clinical value, automates the detection of metastatic disease hotspots and aids clinical decisions. This partnership could expand Lantheus's reach in precision medicine.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced executive presentations at two investor conferences in November 2020. The first is the Credit Suisse 29th Annual Virtual Healthcare Conference on November 11, at 9:30 AM ET, featuring CEO Mary Anne Heino and CFO Bob Marshall. The second is the Jefferies Virtual London Healthcare Conference on November 17, at 8:20 AM ET, with CFO Bob Marshall. Live webcasts will be available on the company's website, with replays accessible for 30 days post-event.
Lantheus Holdings (NASDAQ: LNTH) has announced a strategic collaboration with Insightec Ltd. to utilize its microbubbles with Insightec's investigational MR-guided Focused Ultrasound (MRgFUS) platform. This partnership aims to assess treatments for glioblastoma and neurodegenerative diseases by temporarily disrupting the blood-brain barrier to enhance chemotherapy delivery. Lantheus will supply microbubbles, while Insightec handles regulatory submissions and commercialization. The collaboration aligns with Lantheus' growth strategy in oncology and addresses significant unmet medical needs in aggressive cancer treatment.
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