U. (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. . For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. Pylarify. , [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 received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. 4. 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. S. INDICATION. 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. Worldwide revenue of $129. 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 Holdings, Inc. 6 million and $425. 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. S. 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. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. NORTH BILLERICA, Mass. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. – Paul Blanchfield, Chief Commercial Officer at Lantheus. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. Contact information For media. Lantheus Holdings, Inc. S. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 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. The results. 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. 48 from the prior year period. 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. NORTH BILLERICA, Mass. S. 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. 3 million for the third quarter 2022, representing an increase of 134. 4 million in revenue, up 25% year over year, and a net loss of $11. 2 million, compared with $129. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Today, we put the spotlight on Lantheus Holdings for the first time. 2 million, compared with $129. Morris MJ, Rowe SP, Gorin MA, et al. Lantheus Holdings, Inc. Since then, Lantheus' sales have more than doubled. The device provides general. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. , a Lantheus company . com. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. In the U. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. U. 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. Syntermed announces its appointment by 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. 1 million for the fourth quarter and full year 2022, representing increases of 103. Lantheus Announces Presentations Featuring PYLARIFY AI at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12, 2023 BEDFORD, Mass. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. Email: [email protected] 04, 2021 07:00 ET | Source: Lantheus Holdings, Inc. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. May 27, 2021 — Today, the FDA approved the 18F-DCFPyL PSMA PET imaging agent (also known as “PyL” for short or by its trade name “PYLARIFY”). Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. “This. Worldwide revenue of $321. The Company’s third quarter 2022 GAAP net income was $61. 0. 1 million, or $0. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. com. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. Find out why LNTH stock is a Strong Buy. 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. Worldwide revenue of $239. 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. with suspected recurrence based on. Greater Chicago Area. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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 (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. 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. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. 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. , Nov. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. 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 expects their fully diluted adjusted earnings per share to be between $0. by year endNORTH BILLERICA, Mass. NORTH BILLERICA, Mass. 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. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. While the company generated $527M in. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Developed by Lantheus, PYLARIFY ® was recently approved by the U. 9% over the prior year periods. D. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 6 million for the fourth quarter of 2021, representing an increase of 103. But. For the full year 2022, Lantheus forecasts PYLARIFY to be in a range of $300M to $325M and their. PYLARIFY® may help detect metastases even when PSA levels are low. Lantheus Receives U. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. 2% for the week as of Friday afternoon,. 3M as the prostate cancer diagnostic agent Pylarify added $143. 18F-DCFPyL is now the first. NORTH BILLERICA, Mass. , Progenics Pharmaceuticals, Inc. S. 9% Sodium Chloride Injection USP. The program is available to HCPs who have completed the PYLARIFY® Reader Training. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. com. 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 Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. CC-BY-4. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. PYLARIFY may be diluted with 0. Our products have practical applications in oncology, cardiology and more. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to expand its portfolio of commercial and clinical-stage radiopharmaceutical assets. 5 million for the first quarter 2023. In the U. Mid-cap Lantheus Holdings has been on a revenue growth spurt boosted by a new product called Pylarify, which helps detect prostate cancer in an imaging test. This is an increase of 200% compared to the previous 30 days. 8% from the prior year period; GAAP net income of $94. 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. 1-800-299-3431. 3 million for the second quarter 2023. About Lantheus Holdings, Inc. Lantheus experienced tremendous growth in last 2 years thanks to the approval of a new imaging agent called PYLARIFY. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. 4% from the prior year period; GAAP net income of $43. S. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. 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. 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. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. Lantheus Holdings, Inc. ir@lantheus. 6 million to the ante. 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 expects to. 2 million for the third quarter 2022, compared to GAAP net loss of $13. 47, as compared to $0. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting September 1, 2023 at 8:30 AM EDT BEDFORD, Mass. Minimum 15 minutes delayed. 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. 2% from the prior year quarter due to. S. We accelerated our growth. Lantheus Receives U. Product Uses . (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. com. 86 for the third quarter 2022, compared to. Pylarify is an injectable agent that helps highlight prostate cancer under a PET scan. (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. “The transaction leverages Lantheus’. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. In the press release they say it will be available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the US by year end. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 2 million, or $0. On-site plant will produce. 0 million and $150. PYLARIFY will be available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the U. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. Q4 adjuested EPS grew +448% Y/Y to $1. This sample claim form is only an example. Phone: 1-800-964-0446. 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. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to expand its portfolio of commercial and clinical-stage radiopharmaceutical assets. , 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. Purpose of this notice. 89 for the second quarter of 2022, representing an increase of approximately $0. But most. Follow the PYLARIFY® injection with an intravenous flush of 0. ” Prostate cancer is a common and usually slow-growing 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. PDF Version. Jul 21, 2022 02:13PM EDT. • Dispose of any unused PYLARIFY in compliance with applicable regulations. 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. S. US Customer Service/Order PYLARIFY®. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. 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:. 01. 37. NORTH BILLERICA, Mass. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. 9 million for the first quarter 2022, representing an increase of 125. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. 3. 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 of. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. --(BUSINESS WIRE)--Dec. About Lantheus With more than 65 years of experience in delivering life. 3 million, compared with $102. 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. 9% sodium chloride injection USP. 978-671-8842. Lastly, net cash provided by operating activities was $108. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. Lantheus Receives U. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. Worldwide revenue of $208. m. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. Compelling Rationale for Lantheus Leverages Lantheus’ radiopharmaceutical leadership in prostate cancer (PYLARIFY) and neuroendocrine tumors (AZEDRA) Solidifies potential to drive long-term, sustainable and diversified revenue, earnings and free cash flow growth Milestone-based structure maintains Lantheus’. 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. 3% from the prior year period. 48 from the prior year period. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 66 from the prior year period. Shares of Lantheus Holdings (LNTH-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 has offices in Massachusetts, New Jersey, Canada and Sweden. 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 . Melissa Downs Senior Director, Corporate Communications 646. Heino , President and Chief Executive Officer of Lantheus . Nov 2014 - Sep 2017 2 years 11 months. 7 million for the second quarter 2022, representing an increase of 121. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. Email: cspyl@lantheus. This sample claim form is only an example. Deploy. 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. In June, Lantheus announced that it has demonstrated the higher efficiency and consistency of the Pylarify AI platform while maintaining the diagnostic accuracy of Prostate-Specific Membrane. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. LNTH is expected to report second-quarter 2022 results on Jul 27. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. , Progenics Pharmaceuticals, Inc. 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. prostate cancer community and are likely to have contributed to the top. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. Lantheus Holdings, Inc. 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. 9% Sodium Chloride Injection, USP. , a Lantheus company 331. 0 million and $150. Accessed May 11, 2022. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. But most. PYLARIFY may be diluted with 0. 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:. S. 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. S. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify. 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. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. 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. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). 4% from the prior year period. Lastly, net cash provided by operating activities was $108. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 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. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. 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. Melissa Downs Senior Director, Corporate Communications 646. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. This is the first and final payment related to the CVRs and is in full satisfaction of Lantheus’ payment obligations related to the CVRs. BEDFORD, Mass. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. Lastly, net cash used in operating activities was $32. “In addition to FDA approval, inclusion in the guidelines. BEDFORD, Mass. S. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. 2 million for the third quarter 2022, compared to GAAP net loss of $13. Lantheus Receives U. com. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). 1 million in the prior year period; GAAP fully diluted net income per share of $1. In the U. Under. 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. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. "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. 7% year-over-year, and progressed our. PYLARIFY is a. May 16, 2022 at 8:00 AM EDT. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. 9% Sodium Chloride Injection USP. The company's. 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. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. Lantheus Reports Second Quarter 2023 Financial Results. PYLARIFY (piflufolastat F18) injection. ET. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. 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. Lantheus Holdings. 17%. 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. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. and EXINI Diagnostics AB. • Assay the dose in a suitable dose calibrator prior to administration. PYLARIFY Injection is designed to detect prostate-specific membrane. 4% 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. 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. Pylarify is the largest growth driver for the company as it comprised 65% of. “Today marks an important day for Lantheus and Progenics. 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. Lantheus Holdings, Inc. • Dispose of any unused PYLARIFY in compliance with applicable regulations. with suspected recurrence based on. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. U. S. NORTH BILLERICA,. 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. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. 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. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. Worldwide revenue of $263. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤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. com. 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. , Sept. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. NEW YORK, Feb. , Sept. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. 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. 86 for the third quarter 2022, compared to. Follow. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. S. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. 50 from the prior year period. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. BEDFORD, Mass. 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. INDICATION. , [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. com. 12. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 50 from the prior year period. PYLARIFY, approved by the FDA in May 2021, is the first commercially and widely available prostate-specific membrane antigen (PSMA) PET imaging agent. An FDA-cleared medical device software, PYLARIFY AI V1. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 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. [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. BEDFORD, Mass. 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. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 1. 6 million worth of sales while DEFINITY contributed $63. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. §287(a). CAS Number: 1423758-00-2. "There are several, and there will be new ones down the. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year.