Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. NEW YORK, Feb. 15. June 12, 2023 08:30 ET | Source: Lantheus Holdings. April 29, 2022 07:07 ET | Source: Lantheus Holdings, Inc. 8 million for the first quarter 2023, representing an increase of 44. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . 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. Lastly, net cash provided by operating activities was $108. 4% from the prior year period; GAAP net income of $43. BEDFORD, Mass. 5 million, representing 61. com. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. NORTH BILLERICA, Mass. The merger agreement was first announced on October 2, 2019 . LNTH is expected to report second-quarter 2022 results on Jul 27. 4 million. PYLARIFY® may help detect metastases even when PSA levels are low. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. For men with prostate cancer, PYLARIFY. This is the first and final payment related to the CVRs and is in full satisfaction of Lantheus’ payment obligations related to the CVRs. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. 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. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 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. , [18F]-DCFPyL was approved by the FDA in May of 2021 and is commercially available as PYLARIFY® (Piflufolastat F 18 Injection) and sold by Lantheus. 45%. m. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. BEDFORD, 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 7 million for the second quarter 2022, representing an increase of 121. com. 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. 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. In the U. PYLARIFY Injection is designed to detect prostate-specific membrane. (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. In the U. “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. We have been thrilled with the response to PYLARIFY in the prostate cancer community, said Mary Anne Heino, President and Chief Executive Officer of Lantheus. 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. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. In the U. 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. , [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. Progenics Pharmaceuticals, 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. 48 from the prior year period. Lantheus Reports Second Quarter 2023 Financial Results. PYLARIFY (piflufolastat F18) injection. PDF Version. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. Fax: 978-436-7296. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. 48 from the prior year period. #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 AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus Holdings. 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. diagnostic radiopharmaceutical. 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. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. The Company’s second quarter 2022 GAAP net income was $43. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Coordination of care. 3% over the prior. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. Purpose of this notice. This was another terrific quarter for Lantheus. 2 million for the fourth quarter and full year 2021, representing an increase of 37. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. “In addition to FDA approval, inclusion in the guidelines. 6 million and $425. 00. 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. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. Pylarify. 9% Sodium Chloride Injection, USP. 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. 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. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). , 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 experienced tremendous growth in last 2 years thanks to the approval of a new imaging agent called PYLARIFY. S. • Dispose of any unused PYLARIFY in compliance with applicable regulations. • Visually inspect the radiopharmaceutical solution. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. S. S. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. C. , [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. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 9% sodium chloride injection USP. 47, as compared to $0. 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. Lantheus Receives U. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 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. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. PYLARIFY is a. D. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. 66 from the prior year period. Lastly, net cash provided by operating activities was $116. Lastly, net cash used in operating activities was $32. This is an increase of 200% compared to the previous 30 days. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. 7 million, compared with $101. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 1M in 2022, following a 25% YoY decline, according to the. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. Lantheus Holdings, Inc. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. About Lantheus Holdings, Inc. 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. INDICATION. 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. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. 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. , a Lantheus company . Outside U. In the U. 54. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. The device provides general. (the “Company”) (NASDAQ: LNTH), an established leader and fully. Heino , President and Chief Executive Officer of Lantheus . This indicates a strong confidence in Pylarify’s growth, even amidst new. Worldwide revenue of $239. , Progenics Pharmaceuticals, Inc. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. S. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. ET. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. is the parent company of Lantheus Medical Imaging, Inc. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. NEW YORK, Jan. 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. is the parent company of Lantheus Medical Imaging, Inc. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. Now turning to cash flow. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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 Announces Presentations Featuring PYLARIFY AI at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12, 2023 BEDFORD, Mass. With 3 million men living with prostate cancer and more than 18. PYLARIFY may be diluted with 0. Lantheus Receives U. 37, surpassing the consensus of $0. 6% and an increase of 25. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. , Sept. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. ir@lantheus. 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. 1 million for the second quarter 2023, compared to GAAP net income of $43. 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. 9% Sodium Chloride Injection USP. This sample claim form is only an example. S. Pylarify PET detected at least one positive lesion in at least one body region (bone, prostate bed, pelvic lymph node, other lymph nodes, or soft tissue) in 60% of these patients. 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. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 8 billion tied up in biobucks. “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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. Under. 4. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. INDICATION. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. by year. May 16, 2022 at 8:00 AM EDT. TechneLite net revenue was $24. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. SOFIE’s Vice President of Sales & Marketing, Mike Parisi, states, “We are thrilled to partner with Lantheus to commercially supply this new and. 47, as compared to $0. com. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. In the U. Our presentations at EANM highlight new data on the clinical utility of our artificial intelligence solution to assess response to prostate cancer therapy,” said Etienne Montagut , Chief Business Officer, Lantheus . 1% and 119. Melissa Downs Senior Director, Corporate Communications 646. February 16, 2023 at 8:30 AM EST. with suspected recurrence based on. Lantheus Holdings, Inc. 12. 29. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. BEDFORD, Mass. S. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. NORTH BILLERICA, Mass. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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 availableEven 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. 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. 1% over the. 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. 0 million and $150. Deploy. All rights reserved. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. Pylarify is the largest growth driver for the company as it comprised 65% of. COMPANY IDENTIFICATION: 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. (NASDAQ:NASDAQ:LNTH) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ETCompany ParticipantsMary Anne Heino – President and Chief Executive Officer Mark. In the last reported quarter, the company’s earnings of 97 cents per share. com. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that the U. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. 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. 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:. 7 million in the same period last year. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. 3% over the prior year. 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 provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Lantheus Holdings, Inc. 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. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. GAAP fully diluted earnings per share were $1. and EXINI Diagnostics AB. Phone: 1-800-964-0446. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. US Customer Service/Order PYLARIFY®. GAAP net. 7 million is being distributed to the holders. 9% sodium chloride injection USP. 3 million, compared with $102. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. , Progenics Pharmaceuticals, Inc. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. PYLARIFY (piflufolastat F18) injection . • Assay the dose in a suitable dose calibrator prior to administration. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. 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. 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; PYLARIFY AI™, an artificial intelligence platform. 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. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. 9% Sodium Chloride Injection, USP. and EXINI Diagnostics AB. 0% from the prior year period. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. 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. , Nov. Read more about Lantheus Announces Top Rated Oral Presentation. Lantheus Holdings, Inc. , Nov. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. S. 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. 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. 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. Jul 28, 2021, 8:00 a. Eastern Time. 9% Sodium Chloride Injection USP. 0 is commercially available in the United States . Lantheus Holdings, Inc ( LNTH 0. "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 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 expects to. S. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. “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. 37, while. BEDFORD, Mass. 1. 50 from the prior year period. , Sept. Pylarify is the largest growth driver for the company as it comprised 65% of. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. 3. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. Lantheus Holdings, Inc. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. In the U. “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. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 1 million for the third quarter of 2021, representing an increase of 134. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. 2 million, compared with $129. Sanchez-Crespo A. Accessed May 11, 2022. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023, with the vast majority of our sequential growth driven by our existing accounts. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). Eastern Time. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. 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. March 29, 2022 at 8:00 AM · 8 min read. NORTH BILLERICA, Mass. 4. 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. 18F-DCFPyL is now the first. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Melissa Downs Senior Director, Corporate Communications 646. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. Nov 2014 - Sep 2017 2 years 11 months. 331 Treble Cove Road . Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. (RTTNews) - Lantheus Holdings Inc. Worldwide revenue of $300. 5 million, representing 61. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) continued market expansion and penetration for our established commercial products, particularly PYLARIFY and DEFINITY, in a competitive environment in which other imaging agents have been approved. 2% for the week as of Friday afternoon,. 1-800-299-3431. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. Image source: The Motley Fool. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. com. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 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. , a Lantheus company. 28 May, 2021, 07:00 ET. 52%) were up 21. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. §287(a). 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. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. February 10, 2022 17:33 ET | Source: Lantheus Holdings, Inc. PYLARIFY may be diluted with 0. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. , [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. Lantheus Holdings, Inc. Lantheus Holdings, inc ( LNTH 2. NORTH BILLERICA, Mass. BEDFORD, Mass. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. The company also received a CE marking in Europe for PYLARIFY AI. 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. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. While the company generated $527M in. 24%) Q2 2021 Earnings Call. 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 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. 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. . FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 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. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. Worldwide revenue of $239. PYLARIFY AI deployment can be facilitated both as a secure web cloud application and as a local. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. , Sept. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. Lantheus Holdings, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. 1-800-299-3431. Worldwide revenue of $102. PYLARIFY PSMA - Where and when. 45 and $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. com.