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. Syntermed announces its appointment by Lantheus Holdings, Inc. Eastern, Monday - Friday © 2023 Lantheus. 1 million for the second quarter of 2021, representing an increase of 121. Lastly, net cash provided by operating activities was $116. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes. 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. Jul 28, 2021, 8:00 a. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 2% for the week as of Friday afternoon,. Lantheus Original Approval date: May 26, 2021. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. Lantheus Holdings Inc. • Calculate the necessary volume to administer based on calibration time and required dose. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. Lantheus' Key Products Driving Growth. Lantheus Receives U. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 1 million for the third quarter 2021, representing an increase of 15. BEDFORD, Mass. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 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. February 10, 2022 17:33 ET | Source: Lantheus Holdings, Inc. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. 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. NORTH BILLERICA, Mass. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. BEDFORD, Mass. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. DULLES, Va. Lantheus Holdings, Inc. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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. 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. Progenics Pharmaceuticals, Inc. Email: [email protected] 04, 2021 07:00 ET | Source: 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. 12. In the U. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. 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 . 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. , Nov. NORTH BILLERICA, Mass. US Customer Service/Order PYLARIFY®. NORTH BILLERICA, Mass. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. Lantheus Holdings, Inc. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. 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. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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. , 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. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. 5 million, representing 61. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 9% sodium chloride injection USP. --(BUSINESS WIRE)--May 27, 2021-- Lantheus Holdings, Inc. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino , President and Chief Executive Officer. , Sept. 2 million for the fourth quarter and full year 2021, representing an increase of 37. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. Lantheus says its technology can help improve the management of prostate cancer patients. m. Lantheus Holdings, Inc. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. LNTH earnings call for the period ending June 30, 2021. “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. D. CC-BY-4. (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. PYLARIFY (piflufolastat F18) injection. 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. It will need to spend additional. 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. , a Lantheus company . This page is intended to serve as notice under 35 U. 8% from the prior year period; GAAP net income of $94. 4. Pylarify. An FDA-cleared medical device software, PYLARIFY AI V1. This is the first and final payment related to the CVRs and is in full satisfaction of Lantheus’ payment obligations related to the CVRs. and EXINI Diagnostics AB. (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. Lastly, net cash provided by operating activities was $108. Lantheus Receives U. Read More. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. com. 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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. S. – Paul Blanchfield, Chief Commercial Officer at Lantheus. Lantheus Announces Presentations Featuring PYLARIFY AI at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12, 2023 BEDFORD, Mass. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. PYLARIFY may be diluted with 0. 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. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. But most. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. PYLARIFY (piflufolastat F18) injection. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancer. “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. (the “Company”) (NASDAQ: LNTH), an established leader and fully. S. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. 61 for the second quarter. 4 million. 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. 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. , Nov. 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. 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. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. 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. com. The device provides general. PYLARIFY injection is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence of recurrent and/or metastatic prostate cancer. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. 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. #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% from the prior year period. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. Melissa Downs Senior Director, Corporate Communications 646. The FDA approved the F 18-labeled prostate-specific membrane antigen (PSMA)–targeted positron emission tomography (PET) imaging agent 18F-DCFPyL (Pylarify) for use in prostate cancer, according to an announcement from the company responsible for the agent, Lantheus Holdings, Inc. (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. 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. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. In the U. Third quarter operating cash. Now turning to cash flow. m. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. PRODUCT NAME: PYLARIFY (piflufolastat F18) injection CAS Number: 1423758-00-2 Product Uses: diagnostic radiopharmaceutical COMPANY. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. 61 per fully diluted share, as compared to GAAP net loss. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. May 16, 2022 at 8:00 AM EDT. In. 8 million, compared to a loss of $21. 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. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. is the parent company of Lantheus Medical Imaging, Inc. disease. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. ir@lantheus. 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. GAAP. -1. 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 artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 7 million for the second quarter 2023, representing an increase of 43. (“the Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. 4% from the prior year period. PYLARIFY Injection is designed to detect prostate-specific membrane. 54, as compared to $0. The company also received a CE marking in Europe for PYLARIFY AI. 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. 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. S. . Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. 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’. m. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. 9% Sodium Chloride Injection, USP. 8 million for the first quarter 2023, representing an increase of 44. CAS Number: 1423758-00-2. “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. 33 for the second quarter 2023, compared. Fax: 978-436-7296. and EXINI Diagnostics AB and anWorldwide revenue of $223. But. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. S. ET. Worldwide revenue of $239. , [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. NORTH BILLERICA, Mass. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. GAAP net. 978-671-8842. In patients with. 37. 97 for the first 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. 89 for the second quarter of 2022, representing an increase of approximately $0. , Progenics Pharmaceuticals, Inc. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men. 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. , 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. is the parent company of Lantheus Medical Imaging, Inc. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). 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 accounted for $160. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. 4% from the prior year period; GAAP net income of $43. Lastly, net cash used in operating activities was $32. 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. February 16, 2023 at 8:30 AM EST. 00. The company reported Q4 adjusted EPS of $1. 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’ 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. PYLARIFY may be diluted with 0. 48 from the prior year period. -1. Lantheus Receives U. 7 million, up 12. Since then, Lantheus' sales have more than doubled. November 3, 2022 at 7:00 AM · 11 min read. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. Lantheus 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 provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. • Assay the dose in a suitable dose calibrator prior to administration. . Email: cspyl@lantheus. 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. S. 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. Worldwide revenue of $300. Develop and deploy marketing strategies to drive ROI, sales and margin. LinkedIn. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. Read more about Lantheus Announces Top Rated Oral Presentation. , Nov. S. com. 50. 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. Their experience with these complex products and established footprint in commercializing PYLARIFY and AZEDRA makes them an ideal collaborator for these programs,” said Joe McCann, Ph. com. Lantheus Holdings, Inc. 5 million for the first quarter 2023. Sanchez-Crespo A. 7% year-over-year, and progressed our. 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. 9 mg ethanol in 0. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud to. Lantheus Holdings, Inc. 86 for the third quarter 2022, compared to. 6 million to the ante. and Progenics Pharmaceuticals, Inc. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Residents Only. Worldwide revenue of $102. 86 per fully diluted share, as compared to GAAP net loss of. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. For men with prostate cancer,. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. 29. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 8 million for the first quarter 2023, representing an increase of 44. S. S. Lantheus Holdings, Inc. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. Visit Investor Site. “In addition to FDA approval, inclusion in the guidelines. 2023 Annual Scan Potential Estimates 12. , Nov. and EXINI Diagnostics AB. 45%. Today, we put the spotlight on Lantheus Holdings for the first time. Lantheus Reports First Quarter 2023 Financial Results. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. Lantheus Holdings, Inc. , a Lantheus company . 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. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino , President and Chief Executive Officer of. m. PYLARIFY PSMA - Where and when. On-site plant will produce. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. PYLARIFY works by binding to PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. 3% over the prior year. United States of America . 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. 1. , a Lantheus company. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. prostate cancer community and are likely to have contributed to the top. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. Lantheus Reports Second Quarter 2023 Financial Results. GAAP. , Sept. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. Image source: The Motley Fool. Director, Corporate Communications. Lantheus Holdings, Inc ( LNTH 0. 28 May, 2021, 07:00 ET. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting September 1, 2023 at 8:30 AM EDT BEDFORD, Mass. Accessed May 11, 2022. In the U. 0 million and $150. 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. But most. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. PYLARIFY (piflufolastat F18) injection . (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. 1 million in the prior year period; GAAP fully diluted net income per share of $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. Based in North Billerica, Mass. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President and Chief Executive Officer. S. 4% from the prior year period ; GAAP net income of $61. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. “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. While the company generated $527M in. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. (NASDAQ:NASDAQ:LNTH) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ETCompany ParticipantsMary Anne Heino – President and Chief Executive Officer Mark. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. While the company generated $527M in. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly availableEven if Bracco were to secure 40%+ share in an expanding F-18 PSMA PET imaging market over the next 3 years, the Truist team still thinks Pylarify and Lantheus are undervalued, especially with the. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. But most. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Mark Kinarney. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. (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. 7 million for the third quarter 2023. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). 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. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. NORTH BILLERICA, Mass. The company reports earnings on November 3, with analysts expecting the company to top last year's results. This indicates a strong confidence in Pylarify’s growth, even amidst new. 7 million for the third quarter 2023. 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. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. 4. 48 from the prior year period. 9, 2020-- Lantheus Holdings, Inc. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 1M in 2022, following a 25% YoY decline, according to the. m. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. , [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. About Lantheus Holdings, Inc. , Nov. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days.