Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. In the U. 47, as compared to $0. PDF. ET. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. GAAP net. Lantheus Receives U. 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. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. Lantheus Holdings, Inc. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. Lantheus Holdings, Inc. We reported revenue of $319. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. “Today marks an important day for Lantheus and Progenics. Lantheus Holdings, Inc. 4% from the prior year period; GAAP net income of $43. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus experienced tremendous growth in last 2 years thanks to the approval of a new imaging agent called PYLARIFY. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. ET. The company's. Jul 21, 2022 02:13PM EDT. Lastly, net cash provided by operating activities was $116. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. 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. Outside U. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Lantheus Receives U. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. NEW YORK, Feb. March 29, 2022 at 8:00 AM · 8 min read. Lantheus Holdings, Inc. Lantheus Receives U. , [18 F]-DCFPyL was approved by the FDA in May of 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. S. Our products have practical applications in oncology, cardiology and more. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm ET, or email [email protected] Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Please refer to the map below for the production site nearest you. Develop and deploy marketing strategies to drive ROI, sales and margin. Lastly, net cash provided by operating activities was $108. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. 3. United States of America . NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. “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. 17%. , Nov. June 12,. The. Worldwide revenue of $321. com. 3% over the prior. US Customer Service/Order PYLARIFY®. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. 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:. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. Progenics Pharmaceuticals, Inc. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. 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. NORTH BILLERICA, Mass. 8% from the prior year period. With 3 million men living with prostate cancer and more than 18. Syntermed announces its appointment by Lantheus Holdings, Inc. 0. (the “Company”) (NASDAQ: LNTH), an established leader and fully. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. PYLARIFY® may help detect metastases even when PSA levels are low. Lantheus Reports First Quarter 2023 Financial Results. 3 million for the third quarter 2022, representing an increase of 134. , VP, Medical Affairs E. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. “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. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. BEDFORD, Mass. NORTH BILLERICA, Mass. 2021 was a year of significant achievements for Lantheus. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. com. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. The. 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. 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. The program is available to HCPs who have completed the PYLARIFY® Reader Training. PYLARIFY injection 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 of recurrent and/or metastatic prostate cancer. com. 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. 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 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,. The approval covers the use of Lu177-PSMA-617 in patients who have metastatic prostate cancer that is hormone-resistant (also known as castrate-resistant) and whose tumors. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. 4% from the prior year period ; GAAP net income of $61. com. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. For men with prostate cancer, PYLARIFY. 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. Billerica, MA 01862 . This was another terrific quarter for Lantheus. patents apply to our products: DEFINITY ® /DEFINITY. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. Lantheus’ product, PYLARIFY, 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. 2% for the week as of Friday afternoon,. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. Visit Investor Site. 1 million for the second quarter 2023, compared to GAAP net income of $43. , Progenics Pharmaceuticals, Inc. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. Heino , President and Chief Executive Officer of Lantheus . PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 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. 646-975-2533. 1M in 2022, following a 25% YoY decline, according to the. com. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. The stock has been a big winner in 2022 thanks to the impressive growth racked up by recently launched imaging agent Pylarify. 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. PET/CT. Pylarify is the largest growth driver for the company as it comprised 65% of. About Lantheus With more than 65 years of experience in delivering life. Product Uses . Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. INDICATION. Read More. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. Lantheus Holdings, Inc. PYLARIFY (piflufolastat F18) injection . 1 million for the third quarter of 2021, representing an increase of 134. 3. Lantheus expects their fully diluted adjusted earnings per share to be between $0. NORTH BILLERICA, Mass. 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. The company reported Q4 adjusted EPS of $1. 37. Senior Director, Investor Relations. In the U. by year. 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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. In the U. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. 9 mg ethanol in 0. 0% from the prior year period. 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. U. Lantheus Receives U. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. In 2023, PYLARIFY, the #1 PSMA PET imaging agent and DEFINITY, the #1 ultrasound enhancing agent, will continue to deliver value for our patients, healthcare professionals, employees, and shareholders. 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. DEFINITY in our in-house manufacturing facility; (v) our ability to successfully launch PYLARIFY AI as a commercial product; (vi) the continuing impact of the global COVID-19 pandemic on our business, supplyPhysicians and staff can use this resource to streamline access and reimbursement for PYLARIFY® (piflufolastat F 18) injection for appropriate patients. Shares of Lantheus Holdings (LNTH-0. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. 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. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. , a Lantheus company. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. Lantheus Holdings, Inc. 2. , Progenics Pharmaceuticals, Inc. Paul joined Lantheus in 2020 and has been an exemplary leader throughout his tenure, demonstrating strong strategic and leadership skills, most notably with the very successful launch of PYLARIFY. 99 for the third quarter of 2022, representing an increase of approximately $0. 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. 61 per fully diluted share, as compared to GAAP net loss. 1% and 119. Read more about Lantheus Announces Top Rated Oral Presentation. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 4 million. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. prostate cancer community and are likely to have contributed to the top. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). INDICATION. and EXINI Diagnostics AB. Eastern Time. is the parent company of Lantheus Medical Imaging, Inc. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. S. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. TechneLite net revenue was $24. 5 million for the first quarter 2023. BEDFORD, Mass. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. 2023 Annual Scan Potential Estimates 12. “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% from the prior year period. 1 million for the second quarter 2022, compared to GAAP net loss of $26. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus Medical Imaging has received approval from the U. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. 978-671-8842. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancerNORTH BILLERICA, Mass. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. , Sept. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. [email protected] 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. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. 6 million worth of sales while DEFINITY contributed $63. 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. S. PYLARIFY, approved by the FDA in May 2021, is the first commercially and widely available prostate-specific membrane antigen (PSMA) PET imaging agent. NORTH BILLERICA, Mass. "It's not like there is only one PSMA molecule that we can radiolabel," said Cameron Foster, director of theranostics at the University of California, Davis. Lantheus Holdings, Inc. 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. m. U. Food and Drug Administration in May 2021. About Lantheus With more than 65 years of experience in delivering life. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Lantheus Holdings, Inc. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. Lantheus Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. 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. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. 3 million, compared with $102. by year endNORTH BILLERICA, Mass. News release. PYLARIFY Injection is designed to detect prostate-specific membrane. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 9% over the prior year periods. 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. 3% over the prior year. #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. PYLARIFY may be diluted with 0. 7 million for the second quarter 2023, representing an increase of 43. The program is available to HCPs who have completed the PYLARIFY® Reader Training. (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. 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. 9, 2020-- Lantheus Holdings, Inc. 9 million, up 33. LNTH earnings call for the period ending June 30, 2021. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. Morris MJ, Rowe SP, Gorin MA, et al. Lantheus' Key Products Driving Growth. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. NORTH BILLERICA, Mass. 9% Sodium Chloride Injection USP. The Company’s third quarter 2022 GAAP net income was $61. About 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. Lantheus’ product, PYLARIFY, 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. , Nov. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. 5 million, representing 61. In patients with. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancer. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. Lantheus Holdings, Inc. with suspected recurrence based on. 7 million is being distributed to the holders. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . November 3, 2022 at 7:00 AM · 11 min read. 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. S. (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. S. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. 31 Mar, 2022, 09:00 ET. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify. 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. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. Lantheus Holdings, inc ( LNTH 2. Worldwide revenue of $102. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Worldwide revenue of $239. Contact information For media. S. 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. PYLARIFY works by binding to PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. is the parent company of Lantheus Medical Imaging, Inc. 2 million, compared with $129. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. On-site plant will produce. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. Lantheus Holdings, Inc. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. 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. As part of the agreement with Novartis, Lantheus will provide PYLARIFY for the selection of patients with prostate cancer and Novartis will provide all PYLARIFY related clinical imaging data to Lantheus. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. 6 million and $425. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 54, as compared to $0. BEDFORD, Mass. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. Email: [email protected] 04, 2021 07:00 ET | Source: Lantheus Holdings, Inc. Developed by Lantheus, PYLARIFY ® was recently approved by the U. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. S. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. 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. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). Billerica, MA 01862 . 0 million and $150. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Their experience with these complex products and established footprint in commercializing PYLARIFY and AZEDRA makes them an ideal collaborator for these programs,” said Joe McCann, Ph. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. This means that a negative PYLARIFY PET/CT scan does not rule out that you have prostate cancer, and a positive PYLARIFY PET/CT scan does not confirm that you have prostate cancer. and EXINI Diagnostics AB. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. PYLARIFY identifies PSMA, the. m. 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. The FDA just recently approved the PSMA (piflfolastat F 18) scan. S. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. Melissa Downs Senior Director, Corporate Communications 646. As a leader in the development, manufacture and commercialization of pioneering diagnostic and therapeutic products, we’re determined to Find, Fight and Follow ® a broad range of diseases. with suspected recurrence based on. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. DULLES, Va. 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. 5 million for the first quarter 2023. Deploy. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. 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 Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. with suspected recurrence based on. This is an increase of 200% compared to the previous 30 days. Based in North Billerica, Mass. , a Lantheus company. 61 for the second quarter. , [18 F]-DCFPyL was approved by the FDA in May of 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. United States of America . PYLARIFY may be diluted with 0. 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. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 5 million, representing 61. 9% Sodium Chloride Injection, USP. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. S. , Progenics Pharmaceuticals, Inc. (RTTNews) - Lantheus Holdings Inc. com. This sample claim form is only an example. 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. . 97 for the first quarter of 2022, representing an increase of approximately $0. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer.