Please refer to the map below for the production site nearest you. “Lantheus delivered another strong quarter and full year, highlighted by revenue performance which increased 38% and 25%, respectively,” said Mary Anne Heino, President and CEO. 0. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. diagnostic radiopharmaceutical. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. 4% from the prior year period; GAAP net income of $43. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. Lantheus Holdings, Inc. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. The company expects to. S. Lantheus Holdings Inc (NASDAQ:LNTH) made significant progress during the quarter with PYLARIFY and DEFINITY in its commercial portfolio, and with PNT2002 and MK-6240 in its pipeline. May 16, 2022 at 8:00 AM EDT. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. #Lantheus was thrilled to be a Gold Sponsor of the 16th Clinical Trials on Alzheimer’s Disease conference (CTAD), which took place from Oct 24-27 in Boston! It was a wonderful opportunity to connect with our partners in the industry and academia who are using our investigational Tau PET imaging agent in their clinical trials. 97 for the first quarter of 2022, representing an increase of approximately $0. NORTH BILLERICA, Mass. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. PYLARIFY may be diluted with 0. News release. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. Today, we put the spotlight on Lantheus Holdings for the first time. Under. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. North Billerica, MA: Progenics Pharmaceuticals, Inc. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. 6 million for the fourth quarter of 2021, representing an increase of 103. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. In the U. Outside U. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. • Assay the dose in a suitable dose calibrator prior to administration. GAAP net loss. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. This agent is similar to the Gallium-68 PSMA-11 agent which was approved in December 2020, except that it can be produced in much greater quantities and distrMarketBeat has tracked 5 news articles for Lantheus this week, compared to 5 articles on an average week. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. 331 Treble Cove Road . . Nov 6, 2021, 2:00 p. 8% from the prior year period; GAAP net income of $94. For International Transportation. The PyLAM is the primary customer facing Lantheus Holdings professional tasked with education of the Prostate Cancer medical referral community on PyLARIFY and the cultivation of productive customer relationships to include HCPs, Advanced Practice Providers, Nurses, Pharmacists, Department Administrators and other key medical and. Strategic architect for the Uro-oncology franchise. 2 million for the fourth quarter and full year 2021, representing an increase of 37. Coordination of care. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. Lantheus Receives U. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. 24%) Q2 2021 Earnings Call. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. 6% and an increase of 25. 9 mg ethanol in 0. Billerica, MA 01862 . Lantheus Receives U. S. com. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. Lantheus Holdings. Melissa Downs Senior Director, Corporate Communications 646. 18F-DCFPyL is now the first. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. S. This other product, even though it was, I'll say, riding the wave of the momentum that. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. , Nov. S. Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA). Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. In the U. 肿瘤学放射性药物 (帮助医疗保健专业人员发现、治疗和跟踪癌症的诊断和治疗方法): ·PYLARIFY(也被称为Piflufolastat F-18、18F-DCFPyL或PyL)是一. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 5 million, representing 61. 33 for the second quarter 2023, compared. NORTH BILLERICA, Mass. Lantheus Holdings’ Pylarify injection is a fluorinated small molecule PSMA-targeted PET imaging agent that allows for the visualization of lymph nodes, bone and soft tissue. Welcome to the Lantheus Third Quarter 2023 Financial Results. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. It will need to spend additional. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. November 3, 2022 at 7:00 AM · 11 min read. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy: Locally Recurrent or New/Progressive PCa: OSPREY COHORT B; Safety; CASE STUDIES; HOW TO USE PYLARIFY® REIMBURSEMENT AND AVAILABILITY; PYLARIFY AI™ PYLARIFY AI™ Overview; What Is PYLARIFY AI™? PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. ET. Lastly, net cash used in operating activities was $32. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. and EXINI Diagnostics AB. m. PYLARIFY® IS UNIQUE. In the U. , Progenics Pharmaceuticals, Inc. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced it will present the following presentations at. PYLARIFY AI™ (aPROMISE) is the only deep learning enabled FDA-cleared medical device software to offer standardized PSMA PET reporting with PYLARIFY AI on PSMA PET/CT images, including those. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. In. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 89 for the second quarter of 2022, representing an increase of approximately $0. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. “PYLARIFY has the potential to contribute meaningful and actionable information that can be used to personalize treatment plans in men with low PSA levels,” said Dr. BEDFORD, Mass. But most. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Melissa Downs. BEDFORD, Mass. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. 7 million, up 12. The Company’s second quarter 2022 GAAP net income was $43. 0% from the prior year period. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. PDF Version. 0% from the prior year period. $ 68. 6 million to the ante. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting May 26, 2022 at 8:00 AM EDT PDF Version Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the. We obtained FDA approval for and successfully launched PYLARIFY®Lantheus will fund the all-cash license of exclusive worldwide rights, excluding certain territories 1, for PNT2002 and PNT2003 with cash on Lantheus’ balance sheet and committed financing. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. 45 and $0. Lantheus Holdings, Inc. 5 stocks we like better than LantheusNano-X reported $2. It is the #1 PSMA PET Imaging. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. For $260m Lantheus secured rights to Point’s two most advanced radioligand therapeutic projects, one of which concerns prostate cancer and hits PSMA – the target for Pylarify and for two Lantheus development-stage therapeutics. 25 reported a year ago. S. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. 31 Mar, 2022, 09:00 ET. Lantheus’ product, PYLARIFY ® (piflufolastat F 18) injection, is a radioactive diagnostic agent indicated for PET imaging of PSMA positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and/or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. PYLARIFY identifies PSMA, the. PYLARIFY seems to be affected by the amount (level) of PSA in your blood. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. , [18 F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. The company is well-positioned to generate substantial free cash flow The cash flow statement provides a detailed overview of the cash inflows and outflows of a company over a specified period. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. This indicates a strong confidence in Pylarify’s growth, even amidst new. 9 million for the first quarter 2022, representing an increase of 125. INDICATION. PYLARIFY is the only PSMA-imaging agent that is widely available through a diverse, multi-partner F18 distributor network, ensuring convenient and reliable supply MARKET ACCESS More than 90% of covered lives have access to PSMA PET with PYLARIFY1 UTILIZATION PYLARIFY is the #1 ordered PSMA PET imaging agent in the U. and EXINI Diagnostics AB and anWorldwide revenue of $223. Lantheus says its technology can help improve the management of prostate cancer patients. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. PYLARIFY® is an imaging agent for PET/CT scans that uses a unique combination of a PSMA-targeted small molecule and the radioactive tracer 18 F to help your doctor make more informed treatment choices based on clear images. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. The Company’s third quarter 2022 GAAP net income was $61. PYLARIFY AI™ is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. 1% over the. m. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. m. Lantheus Holdings, Inc. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 4 million. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. June 12,. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. Jul 28, 2021, 8:00 a. PYLARIFY® may help detect metastases even when PSA levels are low. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. On the fourth-quarter 2022 earnings call in February, Lantheus Holdings’ management confirmed that it has been registering a robust uptick in sales of its PYLARIFY, an F 18-labelled PSMA. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. June 12, 2023 at 8:30 AM EDT. 1 million for the fourth quarter and full year 2022, representing increases of 103. US Customer Service/Order PYLARIFY®. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. CC-BY-4. with suspected recurrence based on. S. In the U. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. C. 3 million for the third quarter 2022, representing an increase of 134. Shares of Lantheus Holdings (LNTH-0. “PYLARIFY has the potential to contribute meaningful and actionable information that can be used to personalize treatment plans in men with low PSA levels,” said Dr. The company reports earnings on November 3, with analysts expecting the company to top last year's results. 4 million in revenue, up 25% year over year, and a net loss of $11. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus Receives U. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify. 9% Sodium Chloride Injection, USP. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. The device provides general. 28 May, 2021, 07:00 ET. 2% for the week as of Friday afternoon,. An FDA-cleared medical device software, PYLARIFY AI V1. 9% sodium chloride injection USP. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. Sanchez-Crespo A. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. 1M in 2022, following a 25% YoY decline, according to the. S. Inject a bolus of 9 mCi (333 MBq) of PYLARIFY® with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi) administered as a single bolus intravenous injection. In the press release they say it will be available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the US by year end. Lantheus expects their fully diluted adjusted earnings per share to be between $0. Greater Chicago Area. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. 9 million, up 33. PYLARIFY® (piflufolastat F 18) Injection Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:. com. --(BUSINESS WIRE)--Dec. PYLARIFY ® (piflufolastat F 18) injection (also known as 18 F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. Even if Bracco were to secure 40%+ share in an expanding F-18 PSMA PET imaging market over the next 3 years, the Truist team still thinks Pylarify and Lantheus are undervalued, especially with the. The creation of artificial high-performance photosynthetic assemblies with a tailorable antenna system to deliver absorbed solar energy to a photosynthetic reaction center,. 2 million, or $0. PYLARIFY is a. S. 0 million and $150. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting September 1, 2023 at 8:30 AM EDT BEDFORD, Mass. Lantheus Holdings, Inc. PYLARIFY –Prostate Cancer Franchise Overview Paul Blanchfield, Chief Commercial Officer Etienne Montagut, Chief Business Officer Aseem Anand, VP of Digital Solutions PYLARIFY Key Opinion Leader Panel Moderator: Bela Denes, M. PYLARIFY Injection is designed to detect prostate-specific membrane. Lantheus presented study results providing independent validation of PYLARIFY AI , the Company s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 men with either high-risk prostate cancer (Cohort A; n=268) or radiologic evidence of recurrence (Cohort B; n=117) OSPREY assessed the sensitivity, specificity, PPV, and NPV in pelvic lymph nodes for PYLARIFY® PET/CT. Read More. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 48 from the prior year period. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. June 12, 2023 08:30 ET | Source: Lantheus Holdings. The Lantheus Protocol: Pylarify Growth May Slow. , Nov. David Crawford, M. GAAP net. Lantheus Holdings, Inc. But most. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. Using PYLARIFY AI™ to locate PSMA-avid lesions and track changes over time, investigators were able to determine that the change in the automated PSMA scan. Assay the dose in a suitable dose calibrator prior to administration. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. , [18 F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. 4% from the prior year period ; GAAP net income of $61. 9% Sodium Chloride Injection, USP. com. 9% over the prior year periods. PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly available throughout the U. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform the way that clinicians manage and treat prostate cancer,” said Jean-Claude Provost, MD, Interim Chief Medical Officer, Lantheus. Find out why LNTH stock is a Strong Buy. Lantheus Holdings, Inc. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. ir@lantheus. Quote. PYLARIFY Injection is designed to detect prostate-specific membrane. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. diagnostic radiopharmaceutical. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis. 47, as compared to $0. 8 million for the first quarter 2023, representing an increase of 44. LNTH earnings call for the period ending June 30, 2021. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 [email protected] has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. Deploy. (the Company) ( NASDAQ: LNTH ), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced it will present the following. The company reported Q4 adjusted EPS of $1. The Company updates its guidance for the first quarter and full year 2023 is as follows: PYLARIFY revenues in 1H23 were $405m - up 82% year-on-year - so it seems clear that PYLARIFY revenues have substantially more growth potential - Lantheus' guidance for total revenues in 2023. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. by year endNORTH BILLERICA, Mass. Worldwide revenue of $321. DULLES, Va. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to expand its portfolio of commercial and clinical-stage radiopharmaceutical assets. , Nov. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. BEDFORD, Mass. 17%. Lantheus Medical Imaging has received approval from the U. , Progenics Pharmaceuticals, Inc. Customer Service: 1-800-299-3431: Hours: 7:30 a. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. Compelling Rationale for Lantheus Leverages Lantheus’ radiopharmaceutical leadership in prostate cancer (PYLARIFY) and neuroendocrine tumors (AZEDRA) Solidifies potential to drive long-term, sustainable and diversified revenue, earnings and free cash flow growth Milestone-based structure maintains Lantheus’. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. , a Lantheus company 331. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. This page is intended to serve as notice under 35 U. About Lantheus Holdings, Inc. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 [email protected] Anne Heino: Thank you, Mark, and good morning to everyone. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. Lantheus Receives U. Worldwide revenue of $129. Lantheus Announces Presentations Featuring PYLARIFY AI at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12, 2023 BEDFORD, Mass. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. • Dispose of any unused PYLARIFY in compliance with applicable regulations. Worldwide revenue of $263. 50 from the prior year period. PYLARIFY® Peer-to-Peer Reader Assistance Program is a complementary program to the PYLARIFY® Reader Training that provides guidance and assistance to healthcare providers on how to accurately read and interpret PYLARIFY® scans. PYLARIFY works with PET/CT technology to produce a combined PET/CT scan that enables the reader of the PET/CT scan to detect and locate the disease. 88 and earnings of $1. In the U. Senior Director, Investor Relations. com. NORTH BILLERICA, Mass. 1 million for the second quarter 2023, compared to GAAP net income of $43. Lantheus Holdings Inc. 54, as compared to $0. Worldwide revenue of $239. Lantheus Holdings, Inc. 0. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. 37, surpassing the consensus of $0. , a Lantheus company. The program is available to HCPs who have completed the PYLARIFY® Reader Training. PDF. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. North Billerica, MA: Progenics Pharmaceuticals, Inc. 5 million for the first quarter 2023. The PyLAM is the primary customer facing Lantheus Holdings professional tasked with education of the Prostate Cancer medical referral community on PyLARIFY and the cultivation of productive customer relationships to include HCPs, Advanced Practice Providers, Nurses, Pharmacists, Department Administrators and other key medical and. 9% Sodium Chloride Injection, USP. Based in North Billerica, Mass. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. S. 0. We executed on our strategy to accelerate growth, diversify our commercial and development portfolios, and position Lantheus as a category leader in the markets we serve. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced PYLARIFY AI data will be presented at the. 1-800-299-3431. Eastern, Monday - Friday © 2023 Lantheus. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. 3M as the prostate cancer diagnostic agent Pylarify added $143. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. PYLARIFY (piflufolastat F18) injection. 99 for the third quarter of 2022, representing an increase of approximately $0. 978-671-8842. 01. Follow the PYLARIFY® injection with an intravenous flush of 0. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. February 16, 2023 at 8:30 AM EST. S. His confidence is backed by Lantheus’s Q3 results which exceeded Street expectations, largely due to the continued strength of their product, Pylarify, and their Precision Diagnostics segment. PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. Lantheus Holdings, Inc. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. S. Lantheus Holdings, inc ( LNTH 2. 96 and $0. Lantheus Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. S. Fax: 978-436-7296. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. Read more about Lantheus Announces Top Rated Oral Presentation. The FDA just recently approved the PSMA (piflfolastat F 18) scan.