25 reported a year ago. NORTH BILLERICA, Mass. Lantheus Receives U. In 2023, PYLARIFY, the #1 PSMA PET imaging agent and DEFINITY, the #1 ultrasound enhancing agent, will continue to deliver value for our patients, healthcare professionals, employees, and shareholders. 978-671-8842. 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; PYLARIFY AI™, an artificial intelligence platform. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. BEDFORD, Mass. Phone: 1-800-964-0446. Lantheus Holdings, Inc. com. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. NORTH BILLERICA, Mass. 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. PYLARIFY seems to be affected by the amount (level) of PSA in your blood. is the parent company of Lantheus Medical Imaging, Inc. Senior Director, Investor Relations. to 6:00 p. 8 million for the first quarter 2023, representing an increase of 44. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 2. 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. 1M in 2022, following a 25% YoY decline, according to the. 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. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. An FDA-cleared medical device software, PYLARIFY AI V1. 8 million for the first quarter 2023, representing an increase of 44. Worldwide revenue of $321. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. price-eps-surprise | Lantheus Holdings, Inc. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. June 12, 2023 08:30 ET | Source: Lantheus Holdings. 6 million for the fourth quarter of 2021, representing an increase of 103. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. PYLARIFY Injection is designed to detect prostate-specific membrane. In the last reported quarter, Lantheus earnings per share (EPS) of $1. 5 million for the first quarter 2023. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. , [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. LinkedIn. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. 7% year-over-year, and progressed our. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. 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. Lantheus Medical Imaging has received approval from the U. LNTH earnings call for the period ending June 30, 2021. Q4 adjuested EPS grew +448% Y/Y to $1. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. Pylarify is labeled with F-18 and homes in on PSMA, a protein that is overexpressed on the surface of more than 90% of. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. 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. m. Lantheus Original Approval date: May 26, 2021. diagnostic radiopharmaceutical. • Dispose of any unused PYLARIFY in compliance with applicable regulations. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. Lastly, net cash provided by operating activities was $116. , June 12, 2023 (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. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. 12. 2 million and $935. – Paul Blanchfield, Chief Commercial Officer at Lantheus. , Nov. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 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:. GAAP. com. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. 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. 47, as compared to $0. BEDFORD, Mass. 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® (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:. PYLARIFY® [package insert]. 37. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. 8% from the prior year period. Lantheus Holdings Inc. S. In the last reported quarter, the company’s earnings of 97 cents per share. 3 million for the third quarter 2022, representing an increase of 134. --(BUSINESS WIRE)--Dec. 9% Sodium Chloride Injection, USP. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. 17%. Contact information For media. 37, surpassing the consensus of $0. 9 million for the first quarter 2022, representing an increase of 125. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. S. Shares of Lantheus Holdings (LNTH-0. 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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. CAS Number: 1423758-00-2. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. Under. , Nov. 3 million for the third quarter 2022, representing an increase of 134. 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. Our products have practical applications in oncology, cardiology and more. 4. Product Uses . In patients with. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. But most. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. 3% from the prior year period. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 0% 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. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. In the U. and EXINI Diagnostics AB. 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. PYLARIFY® is an imaging agent for PET/CT scans that uses a unique combination of a PSMA-targeted small molecule and the radioactive tracer 18 F to help your doctor make more informed treatment choices based on clear images. Visit Investor Site. S. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). 18F-DCFPyL is now the first. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 15. The FDA just recently approved the PSMA (piflfolastat F 18) scan. 4% from the prior year period ; GAAP net income of $61. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. NORTH BILLERICA, Mass. , Nov. 4% from the prior year period ; GAAP net income of $61. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. 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. 1% over the. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. 0% from the prior year period. Lantheus Receives U. Even if Bracco were to secure 40%+ share in an expanding F-18 PSMA PET imaging market over the next 3 years, the Truist team still thinks Pylarify and Lantheus are undervalued, especially with the. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. June 12,. , Progenics Pharmaceuticals, Inc. Find out why LNTH stock is a Strong Buy. 54. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. 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 Holdings, Inc. Eastern Time. 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. , [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. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. 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 Holdings, Inc. 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. PYLARIFY® IS UNIQUE. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. S. --(BUSINESS WIRE)--May 27, 2021-- Lantheus Holdings, Inc. 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. UAB Therapy Intensive Program – for Technologists. PYLARIFY Injection is designed to detect prostate-specific membrane. PDF. ET. S. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. Lantheus Holdings, Inc. 00. LNTH is expected to report second-quarter 2022 results on Jul 27. Purpose of this notice. , Nov. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. 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’. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. , Nov. The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. In the U. In the U. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the. 9 mg ethanol in 0. 36%) Q3 2021 Earnings Call. 1 million in the prior year period; GAAP fully diluted net income per share of $1. PYLARIFY was approved by the U. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. 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. 86 for the third quarter 2022, compared to. Pylarify is the largest growth driver for the company as it comprised 65% of. Today, we put the spotlight on Lantheus Holdings for the first time. Email: cspyl@lantheus. §287(a). Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. 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. Morris MJ, Rowe SP, Gorin MA, et al. Develop and deploy marketing strategies to drive ROI, sales and margin. 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. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. 97 for the first quarter of 2022, representing an increase of approximately $0. Assay the dose in a suitable dose calibrator prior to administration. 47, as compared to $0. 9% Sodium Chloride Injection USP. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Lantheus says its technology can help improve the management of prostate cancer patients. S. • Visually inspect the radiopharmaceutical solution. NEW YORK, Jan. TechneLite net revenue was $24. 9 million, up 33. 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. 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. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. , Progenics Pharmaceuticals, Inc. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. On-site plant will produce. The stock has been a big winner in 2022 thanks to the impressive growth racked up by recently launched imaging agent Pylarify. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancer. The Company’s second quarter 2022 GAAP net income was $43. For International Transportation Emergencies Call CC-BY-4. with suspected recurrence based on. Lantheus Holdings, Inc. S. 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 delivered another strong quarter and full year, highlighted by revenue performance which increased 38% and 25%, respectively,” said Mary Anne Heino, President and CEO. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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. 3 million, compared with $102. Lastly, net cash provided by operating activities was $108. Melissa Downs. Lantheus Holdings, Inc. PYLARIFY identifies PSMA, the. 7 million for the second quarter 2023, representing an increase of 43. 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. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. 4% from the prior year period. Even if Bracco were to secure 40%+ share in an expanding F-18 PSMA PET imaging market over the next 3 years, the Truist team still thinks Pylarify and Lantheus are undervalued, especially with the. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. 61 for the second quarter. 47, as compared to $0. Lantheus también está trabajando en el desarrollo de productos para otros tipos de cáncer, como los tumores neuroendocrinos, y en el diagnóstico y estadificación de la. S. m. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. Sanchez-Crespo A. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). S. • Calculate the necessary volume to administer based on calibration time and required dose. m. February 16, 2023 at 8:30 AM EST. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Lantheus Holdings, Inc. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. PYLARIFY Injection is designed to detect prostate-specific membrane. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. 52%) were up 21. PYLARIFY is a. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. and Progenics Pharmaceuticals, Inc. 33 for the second quarter 2023, compared. Lantheus provides a broad. NORTH BILLERICA, Mass. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. In the U. 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. 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. , [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. Read More. 89 for the second quarter of 2022, representing an increase of approximately $0. 331 Treble Cove Road . 52%) were up 21. D. 9% Sodium Chloride Injection, USP. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. com. com. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. Image source: The Motley Fool. Pylarify is the largest growth driver for the company as it comprised 65% of. This other product, even though it was, I'll say, riding the wave of the momentum that. Lantheus Receives U. 3 million for the second quarter 2023. 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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. “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. 6% and an increase of 25. 9% Sodium Chloride Injection, USP. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. 9 mg ethanol in 0. 97 for the first quarter of 2022, representing an increase of approximately $0. com. “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. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. 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. 50 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; TechneLite ® (Technetium Tc99m Generator), a. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. S. m. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. 37. 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. -1. S. 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. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. 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), which was approved in 2021 by the Food and Drug Administration, is a. Image source: The Motley Fool. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. But. Developed by Lantheus, PYLARIFY ® was recently approved by the U. U. CC-BY-4. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. PYLARIFY (piflufolastat F 18) injection (also known as 18 F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. The company's. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. In the U. 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. 3% over the prior. NORTH BILLERICA, Mass. and EXINI Diagnostics AB. But most. 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. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. 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. U. (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. “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. 01. Even if Bracco were to secure 40%+ share in an expanding F-18 PSMA PET imaging market over the next 3 years, the Truist team still thinks Pylarify and Lantheus are undervalued, especially with the. S. 0 is commercially available in the United States . 4% from the prior year period; GAAP net income of $43. S. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. U. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. It will need to spend additional. For the full year 2022, Lantheus forecasts PYLARIFY to be in a range of $300M to $325M and their. D. , Nov. , Nov. Lantheus Receives U. NORTH BILLERICA, Mass. A sample CMS-1500 claim form for billing PYLARIFY® is provided below.