“We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. BEDFORD, Mass. (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. The device provides general. This is the first and final payment related to the CVRs and is in full satisfaction of Lantheus’ payment obligations related to the CVRs. 7% year-over-year, and progressed our. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. [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. 4% from the prior year period; GAAP net income of $43. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. 24%) Q2 2021 Earnings Call. Our products have practical applications in oncology, cardiology and more. S. In the U. 8M of net sales while cardiovascular ultrasound enhancement. Welcome to the Lantheus Third Quarter 2023 Financial Results. , [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. Food and Drug Administration (FDA) has approved. 9, 2020-- Lantheus Holdings, Inc. 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. Follow. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. 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. 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. 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. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 2 million for the third quarter 2022, compared to GAAP net loss of $13. “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. Minimum 15 minutes delayed. 9% Sodium Chloride Injection USP. United States of America . PYLARIFY seems to be affected by the amount (level) of PSA in your blood. LNTH earnings call for the period ending June 30, 2021. David Crawford, M. Progenics Pharmaceuticals, Inc. , Nov. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. S. 2 million, or $0. June 12, 2023 08:30 ET | Source: Lantheus Holdings. 1 million for the fourth quarter and full year 2022, representing increases of 103. S. 0. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. to 6:00 p. Lantheus Holdings, Inc. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Lantheus Holdings. NORTH BILLERICA, Mass. 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. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. by year endNORTH BILLERICA, Mass. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, 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:. Follow the PYLARIFY® injection with an intravenous flush of 0. 5 million, representing 61. March 29, 2022 at 8:00 AM · 8 min read. 86 for the third quarter 2022, compared to. 29. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. Product Uses . , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. Based in North Billerica, Mass. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. 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. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. PYLARIFY Injection is designed to detect prostate-specific membrane. As part of the agreement with Novartis, Lantheus will provide PYLARIFY for the selection of patients with prostate cancer and Novartis will provide all PYLARIFY related clinical imaging data to Lantheus. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. , VP, Medical Affairs E. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. On-site plant will produce. S. S. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 1% over the. 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. 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. The. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. 3 million for the second quarter 2023. 9% Sodium Chloride Injection, USP. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. S. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. S. m. Lantheus Holdings, inc ( LNTH 2. GAAP. m. 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. All rights reserved. May 16, 2022 at 8:00 AM EDT. S. 45 and $0. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Senior Director, Investor Relations. Lantheus Holdings, Inc. 45%. 6 million to the ante. NORTH BILLERICA,. C. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. Assay the dose in a suitable dose calibrator prior to administration. --(BUSINESS WIRE)--Dec. 8 billion tied up in biobucks. 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. diagnostic radiopharmaceutical. 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. com. 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. 52%) were up 21. DEFINITY in our in-house manufacturing facility; (v) our ability to successfully launch PYLARIFY AI as a commercial product; (vi) the continuing impact of the global COVID-19 pandemic on our business, supplyPhysicians and staff can use this resource to streamline access and reimbursement for PYLARIFY® (piflufolastat F 18) injection for appropriate patients. and EXINI Diagnostics AB and anWorldwide revenue of $223. Lantheus Receives U. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. D. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Accessed May 11, 2022. “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. (LNTH) 1 Like. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 7 million, up 12. Shares of Lantheus Holdings (LNTH-0. Lantheus Receives U. (the “Company”) (NASDAQ: LNTH), an established leader and fully. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 3 million for the third quarter 2022, representing an increase of 134. S. diagnostic radiopharmaceutical. INDICATION. • Visually inspect the radiopharmaceutical solution. Syntermed announces its appointment by Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. 8 million, compared to a loss of $21. , [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. Product Uses . PYLARIFY® IS UNIQUE. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. 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. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. Lantheus Holdings, Inc. distributor of PYLARIFY AI™, the first and only FDA-cleared artificial intelligence platform developed to assist standardized quantification of PSMA PET/CT scans. In the U. 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. May 16, 2022 at 8:00 AM EDT. 5 stocks we like better than LantheusNano-X reported $2. istering PYLARIFY. (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. Worldwide revenue of $239. “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. , Progenics Pharmaceuticals, Inc. 0 million and $150. Lantheus Receives U. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. Jul 21, 2022 02:13PM EDT. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. 6 million for the fourth quarter of 2021, representing an increase of 103. Heino , President and Chief Executive Officer of Lantheus . com. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. 2 million, compared with $129. Image source: The Motley Fool. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 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. 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. In the U. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. PYLARIFY may be diluted with 0. 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. S. February 10, 2022 17:33 ET | Source: Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. 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. S. The approval covers the use of Lu177-PSMA-617 in patients who have metastatic prostate cancer that is hormone-resistant (also known as castrate-resistant) and whose tumors. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. Lantheus Holdings, Inc. , Nov. S. About Lantheus With more than 65 years of experience in delivering life. Morris MJ, Rowe SP, Gorin MA, et al. 8% from the prior year period. The company reported Q4 adjusted EPS of $1. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 3% from the prior year period. GAAP net loss. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. Pylarify is the largest growth driver for the company as it comprised 65% of. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. GAAP fully diluted earnings per share were $1. , a Lantheus company. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. "There are several, and there will be new ones down the. prostate cancer community and are likely to have contributed to the top. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. Lantheus Receives U. #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. 0 million and $150. May 4, 2023 at 7:00 AM · 10 min read. • Dispose of any unused PYLARIFY in compliance with applicable regulations. In the U. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. “Today marks an important day for Lantheus and Progenics. Greater Chicago Area. Pylarify. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. BEDFORD, Mass. 7 million for the third quarter 2023. “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. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. 9% Sodium Chloride Injection, USP. “PYLARIFY AI is the first and only FDA-cleared medical device software that offers a standardized platform for quantifying PSMA PET/CT images,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. PYLARIFY Injection is designed to detect prostate-specific membrane. The company expects to. “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. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. ET. com. NORTH BILLERICA, Mass. 18F-DCFPyL is now the first. , May 11, 2022 (GLOBE NEWSWIRE) -- 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; TechneLite ® (Technetium Tc99m Generator), a. 9 million for the first quarter 2022, representing an increase of 125. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men. Lastly, net cash used in operating activities was $32. 9% Sodium Chloride Injection, USP. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. 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. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). LNTH-1095 (also known as MIP-1095) is a small molecule PSMA-targeted 131 I-based radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) which combines a PSMA-targeted ligand, LNTH-1095, with the beta-emitting radioisotope 131 I. Lantheus Receives U. --(BUSINESS WIRE)--May 27, 2021-- Lantheus Holdings, Inc. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. (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. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. PYLARIFY is the 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. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. While the company generated $527M in. 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. NORTH BILLERICA, Mass. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. 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. Lastly, net cash provided by operating activities was $108. Outside U. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. 99 for the third quarter of 2022, representing an increase of approximately $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 technetium-based generator. October 19, 2023. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. m. NEW YORK, Jan. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancerNORTH 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. US Customer Service/Order PYLARIFY®. Lastly, net cash provided by operating activities was $116. For International Transportation. PDF Version. m. 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. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. Pylarify is the largest growth driver for the company as it comprised 65% of. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Image source: The Motley Fool. Lantheus Holdings, Inc. 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. This page is intended to serve as notice under 35 U. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. . (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced it will present the following presentations at. The Lantheus Protocol: Pylarify Growth May Slow. NORTH BILLERICA, Mass. 25 reported a year ago. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. Melissa Downs. 3 million, compared with $102. is the parent company of Lantheus Medical Imaging, 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. Purpose of this notice. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. Pylarify. Lantheus Receives U. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. . Phone: 1-800-964-0446. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. , [18 F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. 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 Imaging Agent for. Lantheus Holdings, Inc. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. ET. , a Lantheus company. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. (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. PDF. 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. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. Residents Only. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. , a Lantheus company . 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. Jul. 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. 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”). April 29, 2022 07:07 ET | Source: Lantheus Holdings, Inc. Quote. 0. Sanchez-Crespo A. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. NORTH BILLERICA, Mass. 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. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. Lantheus provides a broad portfolio of products, including PYLARIFY. Published online May 11, 2022. Worldwide revenue of $102. PYLARIFY is a. 5 million for the first quarter 2023. But most. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. patents apply to our products: DEFINITY ® /DEFINITY. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. BEDFORD, Mass. 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 may be diluted with 0. S. With 3 million men living with prostate cancer and more than 18 million adults. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. This sample claim form is only an example. 1. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. NORTH BILLERICA, Mass. 48 from the prior year period. Strategic architect for the Uro-oncology franchise. But most. November 3, 2022 at 7:00 AM · 11 min read. Worldwide revenue of $321. Read More. 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 AI is an FDA-cleared medical device software and is commercially available in the United States . Lantheus Holdings, Inc. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact 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; PYLARIFY AI™, an artificial intelligence platform. 1 million for the third quarter of 2021, representing an increase of 134. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. S. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. 97 for the first quarter of 2022, representing an increase of approximately $0. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. 00. Find out why LNTH stock is a Strong Buy. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7.