54, as compared to $0. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. 2% from the prior year quarter due to. 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. 9% Sodium Chloride Injection USP. Product Uses . S. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. The results. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. In the U. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Worldwide revenue of $239. 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. 3% over the prior. 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. In patients with. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. S. 7 million for the second quarter 2023, representing an increase of 43. On-site plant will produce. , 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. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. 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 million, or $0. March 29, 2022 at 8:00 AM · 8 min read. GAAP. 2. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. , Nov. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. istering PYLARIFY. 1 million for the second quarter 2023, compared to GAAP net income of $43. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. NORTH BILLERICA, Mass. Lantheus' Key Products Driving Growth. Lantheus Receives U. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. In the U. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. , [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. BEDFORD, Mass. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Billerica, MA 01862 . 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. 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. Lantheus Holdings, Inc. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Purpose of this notice. 15. 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. Deploy. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. 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. Follow the PYLARIFY® injection with an intravenous flush of 0. , a Lantheus company . 9% over the prior year periods. Lantheus Holdings, Inc. UAB Therapy Intensive Program – for Technologists. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. 25 reported a year ago. 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. Greater Chicago Area. com. In the U. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. Lastly, net cash used in operating activities was $32. Minimum 15 minutes delayed. 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. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. (the Company) (NASDAQ: LNTH), a company committed to“PYLARIFY AI has the potential to contribute meaningful insights to inform treatment selection and monitoring in prostate cancer. 4% 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. The company reported Q4 adjusted EPS of $1. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. For men with prostate cancer, PYLARIFY. 28 May, 2021, 07:00 ET. 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 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 Receives U. Lantheus provides a broad. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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. In. The following U. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. 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. “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. 4% from the prior year period ; GAAP net income of $61. 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. May 16, 2022 at 8:00 AM EDT. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. 331 Treble Cove Road . The Company’s second quarter 2022 GAAP net income was $43. Progenics Pharmaceuticals, Inc. PYLARIFY is a. 1 million for the second quarter 2022, compared to GAAP net loss of $26. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). (“the Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. 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. S. Worldwide revenue of $263. “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. disease. diagnostic radiopharmaceutical. Lantheus Holdings, Inc. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. 17%. 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. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. NORTH BILLERICA, Mass. 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. PYLARIFY, approved by the FDA in May 2021, is the first commercially and widely available prostate-specific membrane antigen (PSMA) PET imaging agent. 0 is commercially available in the United States . 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® 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. 97 for the first quarter of 2022, representing an increase of approximately $0. 8 million for the first quarter 2023, representing an increase of 44. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. Lantheus Reports Second Quarter 2023 Financial Results. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. PYLARIFY® [package insert]. S. PYLARIFY AI™ is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. This agent is similar to the Gallium-68 PSMA-11 agent which was approved in December 2020, except that it can be produced in much greater quantities and distrMarketBeat has tracked 5 news articles for Lantheus this week, compared to 5 articles on an average week. 97 for the first quarter of 2022, representing an increase of approximately $0. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. 24%) Q2 2021 Earnings Call. is the parent company of Lantheus Medical Imaging, Inc. Lantheus Original Approval date: May 26, 2021. 4 million. 5 million for the first quarter 2023. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. But most. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. S. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. , [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. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. NORTH BILLERICA, Mass. Lantheus spent months preparing for PYLARIFY's launch and has scaled up the company's commercial, medical, and manufacturing capabilities to ensure the launch is successful. , Nov. 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. 7 million in the same period last year. S. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. Follow. NORTH BILLERICA, Mass. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. NEW YORK, Jan. 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. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. ET. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. 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. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. 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. INDICATION. Worldwide revenue of $102. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. About Lantheus With more than 65 years of experience in delivering life. 7 million for the second quarter 2023, representing an increase of 43. 29. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. This other product, even though it was, I'll say, riding the wave of the momentum that. , Nov. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Contact information For media. February 10, 2022 17:33 ET | Source: Lantheus Holdings, Inc. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. November 3, 2022 at 7:00 AM · 11 min read. 3. Jul 21, 2022 02:13PM EDT. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. (the “Company”) (NASDAQ: LNTH), an established leader and fully. 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. Lantheus Medical Imaging has received approval from the U. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. INDICATION. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 1M in 2022, following a 25% YoY decline, according to the. This sample claim form is only an example. 5 million, representing 61. with suspected recurrence based on. The company is well-positioned to generate substantial free cash flow The cash flow statement provides a detailed overview of the cash inflows and outflows of a company over a specified period. Image source: The Motley Fool. 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 Holdings, Inc. PET/CT. Lantheus Holdings, Inc. PDF Version. Lantheus Holdings, Inc. 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. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. Eastern Time. CC-BY-4. 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. §287(a). com. 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. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 9% Sodium Chloride Injection, USP. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 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. com. BEDFORD, Mass. Lantheus Receives U. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. com. “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. S. • Assay the dose in a suitable dose calibrator prior to administration. S. Lantheus Holdings, Inc. 3. 48 from the prior year period. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. 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. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. LinkedIn. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. PYLARIFY® Peer-to-Peer Reader Assistance Program is a complementary program to the PYLARIFY® Reader Training that provides guidance and assistance to healthcare providers on how to accurately read and interpret PYLARIFY® scans. PYLARIFY® (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:. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 4. In the U. TechneLite net revenue was $24. 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. Fax: 978-436-7296. S. S. price-eps-surprise | Lantheus Holdings, Inc. 5 million, representing 61. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. With 3 million men living with prostate cancer and more than 18 million adults. to 6:00 p. PYLARIFY (piflufolastat F18) injection . Senior Director, Investor Relations. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. Sanchez-Crespo A. NORTH BILLERICA, Mass. , Nov. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. ” Prostate cancer is a common and usually slow-growing cancer. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. PYLARIFY® IS UNIQUE. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. 3 million for the third quarter 2022, representing an increase of 134. 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® may help detect metastases even when PSA levels are low. We reported revenue of $319. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. 9 million for the first quarter 2022, representing an increase of 125. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Jul 28, 2021, 8:00 a. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. S. 2 million, compared with $129. 86 for the third quarter 2022, compared to. S. TechneLite net revenue was $24. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. Visit Investor Site. Developed by Lantheus, PYLARIFY ® was recently approved by the U. 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. 6% and an increase of 25. 3% from the prior year period. 37, surpassing the consensus of $0. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm ET, or email [email protected] Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. is the parent company of Lantheus Medical Imaging, Inc. In the U. 37, while. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. 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 . Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA). Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. -1. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. 4% from the prior year period. Worldwide revenue of $321. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. 6 million to the ante. GAAP net. 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. 50 from the prior year period. • Dispose of any unused PYLARIFY in compliance with applicable regulations. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on. (RTTNews) - 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. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 2% from the prior year quarter due to. as the first U. 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. OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 men with either high-risk prostate cancer (Cohort A; n=268) or radiologic evidence of recurrence (Cohort B; n=117) OSPREY assessed the sensitivity, specificity, PPV, and NPV in pelvic lymph nodes for PYLARIFY® PET/CT. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. Lantheus Holdings, Inc. , a Lantheus company . Lantheus says its technology can help improve the management of prostate cancer patients. , Sept. 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) (NASDAQ: LNTH), a company committed to“Lantheus is a demonstrated commercial leader in the field of radiopharmaceuticals. 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 Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. (LNTH) 1 Like. – Paul Blanchfield, Chief Commercial Officer at Lantheus. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. 96 and $0. INDICATION. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 2 million for the third quarter 2022, compared to GAAP net loss of $13. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. Progenics Pharmaceuticals, Inc. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. , [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 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. 7 million for the second quarter 2022, representing an increase of 121. 3 million for the second quarter 2023. Quote. 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 for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the. commercial products, particularly PYLARIFY and DEFINITY, in the face of competition; (ii) our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house. Worldwide revenue of $239. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. The PyLAM is the primary customer facing Lantheus Holdings professional tasked with education of the Prostate Cancer medical referral community on PyLARIFY and the cultivation of productive customer relationships to include HCPs, Advanced Practice Providers, Nurses, Pharmacists, Department Administrators and other key medical and. 9% sodium chloride injection USP. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. 7 million for the third quarter 2023.