Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. 8% 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. 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. to 6:00 p. Lantheus Holdings, Inc. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. PYLARIFY® CODING AND BILLING GUIDE | PYLARIFY® Reimbursement Hotline: 844-339-8514 PYLARIFY® and the associated services provided in a physician office are billed on the CMS-1500 claim form or its electronic equivalent. Contacts: Mark Kinarney Vice President, Investor Relations978-671-8842 [email protected] will provide further details on the PYLARIFY launch to date in a few minutes, but I am thrilled that less than one year after we commenced our launch, more than 30,000 men have been imaged. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 61 per fully diluted share, as compared to GAAP net loss. 48 from the prior year period. May 16, 2022 at 8:00 AM EDT. 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. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. BEDFORD, Mass. "There are several, and there will be new ones down the. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. Lastly, net cash provided by operating activities was $108. 2021 was a year of significant achievements for Lantheus. North Billerica, MA: Progenics Pharmaceuticals, 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; PYLARIFY AI™, an artificial intelligence platform. 7 million is being distributed to the holders. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. The company reported Q4 adjusted EPS of $1. 0% from the prior year period. PYLARIFY AI is an FDA-cleared artificial intelligence 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. BEDFORD, Mass. 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:. Nov 6, 2021, 2:00 p. com. Deploy. May 4, 2023 at 7:00 AM · 10 min read. istering PYLARIFY. “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. 36%) Q3 2021 Earnings Call. 1% over 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. 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. m. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. For International Transportation Emergencies Call CC-BY-4. 47, as compared to $0. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. S. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President and Chief Executive Officer. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 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 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. 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. PYLARIFY® CODING AND BILLING GUIDE | PYLARIFY® Reimbursement Hotline: 844-339-8514 PYLARIFY® and the associated services provided in a physician office are billed on the CMS-1500 claim form or its electronic equivalent. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. In the U. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. In the U. 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. 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® (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. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. 3 million, compared with $102. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. “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. S. 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. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. Develop and deploy marketing strategies to drive ROI, sales and margin. , May 11, 2022 (GLOBE NEWSWIRE) -- 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. S. Billerica, MA 01862 . 6 million worth of sales while DEFINITY contributed $63. Third quarter operating cash. S. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. com. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Please refer to the map below for the production site nearest you. B Riley has resumed coverage of Lantheus Holdings (NASDAQ:LNTH) with a buy citing the company's growth trajectory due to the the launch of Pylarify, a prostate-specific membrane antigen (PSMA. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. , Nov. S. 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’ 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. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. by year. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. (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. The merger agreement was first announced on October 2, 2019 . 9 mg ethanol in 0. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. , Progenics Pharmaceuticals, Inc. 0 million and $150. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. , Progenics Pharmaceuticals, Inc. “PYLARIFY AI is the first and only FDA-cleared medical device software that offers a standardized platform for quantifying PSMA PET/CT images,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Developed by Lantheus, PYLARIFY ® was recently approved by the U. 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. S. 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. 9 million for the first quarter 2022, representing an increase of 125. “This. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. diagnostic radiopharmaceutical. 37, surpassing the consensus of $0. 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. “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. S. The company reports earnings on November 3, with analysts expecting the company to top last year's results. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. 1% over the. 18F-DCFPyL is now the first. 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. Sanchez-Crespo A. 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. Melissa Downs Senior Director, Corporate Communications 646-975-2533 media@lantheus. com. Lantheus Reports Second Quarter 2023 Financial Results. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. 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. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. PYLARIFY Injection is designed to detect prostate-specific membrane. 9 mg ethanol in 0. , Professor of Urology, University of California San DiegoLantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. U. October 19, 2023. 52%) were up 21. PYLARIFY® may help detect metastases even when PSA levels are low. 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. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. Lantheus credited the revenue rise from increased sales for its Pylarify PSMA PET imaging agent, used to detect recurrent or metastatic prostate cancer, as well as increased use of its Definity. (RTTNews) - Lantheus Holdings Inc. Eastern, Monday - Friday © 2023 Lantheus. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly available Lantheus delivered a BIG and welcome beat-and-raise quarter and shares were up as much as +20%, poking their nose over $71. , Sept. “Today marks an important day for Lantheus and Progenics. 5 stocks we like better than LantheusNano-X reported $2. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . S. and EXINI Diagnostics AB. DULLES, Va. Lantheus Holdings, Inc. 9% Sodium Chloride Injection, USP. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus Receives U. Lastly, net cash provided by operating activities was $108. For men with prostate cancer,. , [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. The following U. , Nov. 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. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. Shares of Lantheus Holdings (LNTH-0. 3% from the prior year period. 0. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. 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. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. The. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. PYLARIFY identifies PSMA, the. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. Worldwide revenue of $239. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. The FDA just recently approved the PSMA (piflfolastat F 18) scan. “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 information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. 5 million for the first quarter 2023. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. Melissa Downs Senior Director, Corporate Communications 646. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. S. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. 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. 1 million for the fourth quarter and full year 2022, representing increases of 103. Under. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. 331 Treble Cove Road . 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 Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. It is the #1 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. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. 9% Sodium Chloride Injection, USP. 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. patents apply to our products: DEFINITY ® /DEFINITY. 15. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. With 3 million men living with prostate cancer and more than 18. Quote. C. 3% over the prior year. 2 million, or $0. 8 million for the first quarter 2023, representing an increase of 44. 9% over the prior year periods. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 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. All rights reserved. Product Uses: diagnostic radiopharmaceutical . Lantheus Holdings, Inc. News release. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 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. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. 1 million for the third quarter of 2021, representing an increase of 134. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. 0. 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. March 29, 2022 at 8:00 AM · 8 min read. Lantheus Holdings, Inc. The Lantheus Protocol: Pylarify Growth May Slow The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. (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. Shares of Lantheus Holdings (LNTH-0. 48 from the prior year period. 0. 4% from the prior year period; GAAP net income of $43. S. PYLARIFY Injection is designed to detect prostate-specific membrane. 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. Progenics Pharmaceuticals, Inc. PDF. Melissa Downs Senior Director, Corporate Communications 646. 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. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. Lantheus Holdings, inc ( LNTH 2. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. S. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. S. Melissa Downs Senior Director, Corporate Communications 646. “In addition to FDA approval, inclusion in the guidelines. 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. Lantheus Holdings, Inc. For men with prostate cancer, PYLARIFY. NORTH BILLERICA, Mass. This indicates a strong confidence in Pylarify’s growth, even amidst new. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. Eastern Time. PRODUCT NAME: PYLARIFY (piflufolastat F18) injection CAS Number: 1423758-00-2 Product Uses: diagnostic radiopharmaceutical COMPANY. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . 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. PYLARIFY AI™ (aPROMISE) is the only deep learning enabled FDA-cleared medical device software to offer standardized PSMA PET reporting on PSMA PET/CT images, including those achieved using. S. 646-975-2533. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. Customer Service: 1-800-299-3431: Hours: 7:30 a. GAAP. S. , [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. S. Worldwide revenue of $208. The company expects to. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. NEW YORK, Feb. Food and Drug Administration (FDA) has approved. 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. But most. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. 7 million for the second quarter 2022, representing an increase of 121. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Lantheus Receives U. Pylarify. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly availableLantheus delivered a BIG and welcome beat-and-raise quarter and shares were up as much as +20%, poking their nose over $71. , a Lantheus company . Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 8 million, compared to a loss of $21. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. 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. Assay the dose in a suitable dose calibrator prior to administration. LNTH is expected to report second-quarter 2022 results on Jul 27. --(BUSINESS WIRE)--Dec. 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. June 12,. 9% Sodium Chloride Injection USP. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. 50 from the prior year period. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancerNORTH BILLERICA, Mass. 52%) were up 21. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. 7 million for the second quarter 2023, representing an increase of 43. by year endNORTH BILLERICA, Mass. Lantheus Holdings, Inc ( LNTH 0. 31 Mar, 2022, 09:00 ET. Lantheus experienced tremendous growth in last 2 years thanks to the approval of a new imaging agent called PYLARIFY. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly available68. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. 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. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. Read more about Lantheus Announces Top Rated Oral Presentation. Fax: 978-436-7296. S. 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. distributor of PYLARIFY AI™, the first and only FDA-cleared artificial intelligence platform developed to assist standardized quantification of PSMA PET/CT scans. “Being selected by Lantheus to partner to administer the first dose of PYLARIFY is an honor, and it’s humbling to know that GenesisCare will be potentially helping men with prostate cancer, while improving access to high-quality care for our patients. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. INDICATION. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. PYLARIFY AI deployment can be facilitated both as a secure web cloud application and as a local. PYLARIFY is a. NORTH BILLERICA, Mass. Read More. For International Transportation. 1-800-299-3431. June 12, 2023 at 8:30 AM EDT. About Lantheus With more than 65 years of experience in delivering life. com. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. 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. 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 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. 17%. Lantheus Holdings, Inc. S. 7% year-over-year, and progressed our. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. This was another terrific quarter for Lantheus. 2% for the week as of Friday afternoon,. 1 million for the second quarter of 2021, representing an increase of 121. NORTH BILLERICA,. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. 8% from the prior year period; GAAP net income of $94. 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. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. diagnostic radiopharmaceutical. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. m. Greater Chicago Area. 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 Holdings. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors. In the U. BEDFORD, Mass. Pylarify is labeled with F-18 and homes in on PSMA, a protein that is overexpressed on the surface of more than 90% of. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. , [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. with suspected recurrence based on.