3M as the prostate cancer diagnostic agent Pylarify added $143. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to expand its portfolio of commercial and clinical-stage radiopharmaceutical assets. com. PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. 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; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. as the first U. 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. 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. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. 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 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 AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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. U. “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 following U. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. ” Prostate cancer is a common and usually slow-growing cancer. $ 68. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 [email protected] Anne Heino: Thank you, Mark, and good morning to everyone. 0. m. 7% year-over-year, and progressed our. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. Lantheus provides a broad portfolio of products, including PYLARIFY. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. NORTH BILLERICA, Mass. 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. Leadership provided initial guidance for FY2023 as well. com. , Nov. 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. • Visually inspect the radiopharmaceutical solution. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. S. • Assay the dose in a suitable dose calibrator prior to administration. For International Transportation. 17%. Worldwide revenue of $239. 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. 61 for the second quarter. PDF Version. “The transaction leverages Lantheus’. 3% from the prior year period. 1-800-299-3431. 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 expects their fully diluted adjusted earnings per share to be between $0. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. 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. 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. 0. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. 2 million, or $0. 9% Sodium Chloride Injection, USP. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. Lantheus Holdings, inc ( LNTH 2. Lantheus Receives U. ,. S. 0 is commercially available in the United States . 3 million for the third quarter 2022, representing an increase of 134. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. 66 from the prior year period. We obtained FDA approval for and successfully launched PYLARIFY®Lantheus will fund the all-cash license of exclusive worldwide rights, excluding certain territories 1, for PNT2002 and PNT2003 with cash on Lantheus’ balance sheet and committed financing. 2 million, compared with $129. [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. 7 million in the same period last year. In the U. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. 4% from the prior year period ; GAAP net income of $61. 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. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. “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. (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. This sample claim form is only an example. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . 97 for the first quarter of 2022, representing an increase of approximately $0. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. 1 million for the fourth quarter and full year 2022, representing increases of 103. Food and Drug Administration (FDA) has approved. Lantheus Receives U. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). , a Lantheus company. 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. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. ir@lantheus. m. 8% from the prior year period. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging. NORTH BILLERICA, Mass. Follow the PYLARIFY® injection with an intravenous flush of 0. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. BEDFORD, Mass. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. diagnostic radiopharmaceutical. 47, as compared to $0. Lantheus spent months preparing for PYLARIFY's launch and has scaled up the company's commercial, medical, and manufacturing capabilities to ensure the launch is successful. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. com. Assay the dose in a suitable dose calibrator prior to administration. NORTH BILLERICA, Mass. Mark Kinarney. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. Melissa Downs Senior Director, Corporate Communications 646. , 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. 7 million for the second quarter 2022, representing an increase of 121. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. S. 7 million for the third quarter 2023. 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. 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 market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. Fax: 978-436-7296. 3. 24%) Q2 2021 Earnings Call. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 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 has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. 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 . S. BEDFORD, Mass. Nov 6, 2021, 2:00 p. 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. S. (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. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. An FDA-cleared medical device software, PYLARIFY AI V1. 31 Mar, 2022, 09:00 ET. May 16, 2022 at 8:00 AM EDT. 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. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 29. 8 million for the first quarter 2023, representing an increase of 44. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. NORTH BILLERICA, Mass. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. Read More. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. Quote. 4% from the prior year period ; GAAP net income of $61. 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. 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. Pylarify. “In addition to FDA approval, inclusion in the guidelines. 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. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. 54. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. “Today marks an important day for Lantheus and Progenics. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual. , Sept. 00. October 19, 2023. 1 million for the second quarter 2023, compared to GAAP net income of $43. Welcome to the Lantheus Third Quarter 2023 Financial Results. PYLARIFY Injection is designed to detect prostate-specific membrane. 5 million, representing 61. 2. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. For men with prostate cancer, PYLARIFY. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Lantheus' Key Products Driving Growth. B Riley has resumed coverage of Lantheus Holdings (NASDAQ:LNTH) with a buy citing the company's growth trajectory due to the the launch of Pylarify, a prostate-specific membrane antigen (PSMA. Jul 28, 2021, 8:00 a. INDICATION. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. DULLES, Va. Develop and deploy marketing strategies to drive ROI, sales and margin. 1 million for the third quarter of 2021, representing an increase of 134. 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. NORTH BILLERICA, Mass. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. ET. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. S. 5 million, representing 61. Visit Investor Site. 9% Sodium Chloride Injection USP. 9% Sodium Chloride Injection, USP. 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. It will need to spend additional. Lantheus Reports Second Quarter 2023 Financial Results. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. , Nov. Since then, Lantheus' sales have more than doubled. Nov 2014 - Sep 2017 2 years 11 months. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. 7 million is being distributed to the holders. Product Uses: diagnostic radiopharmaceutical . Minimum 15 minutes delayed. With 3 million men living with prostate cancer and more than 18 million adults. 9 million, up 33. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. by year. distributor of PYLARIFY AI™, the first and only FDA-cleared artificial intelligence platform developed to assist standardized quantification of PSMA PET/CT scans. , a Lantheus company . 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. . We executed on our strategy to accelerate growth, diversify our commercial and development portfolios, and position Lantheus as a category leader in the markets we serve. Lantheus provides a broad. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. NORTH BILLERICA, Mass. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. 37, surpassing the consensus of $0. , [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. In the last reported quarter, Lantheus earnings per share (EPS) of $1. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. Find out why LNTH stock is a Strong Buy. com. 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. GAAP net. 37. NORTH BILLERICA, Mass. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. , Nov. 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. Eastern Time. Worldwide revenue of $239. Worldwide revenue of $321. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. , Nov. This other product, even though it was, I'll say, riding the wave of the momentum that. 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. 2023 Annual Scan Potential Estimates 12. Assay the dose in a suitable dose calibrator prior to administration. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. and EXINI Diagnostics AB and anWorldwide revenue of $223. 99 for the third quarter of 2022, representing an increase of approximately $0. The program is available to HCPs who have completed the PYLARIFY® Reader Training. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. S. Food and Drug Administration in May 2021. NEW YORK, Jan. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. (the Company) (NASDAQ: LNTH), a company committed to“Lantheus is a demonstrated commercial leader in the field of radiopharmaceuticals. May 4, 2023 at 7:00 AM · 10 min read. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy: Locally Recurrent or New/Progressive PCa: OSPREY COHORT B; Safety; CASE STUDIES; HOW TO USE PYLARIFY® REIMBURSEMENT AND AVAILABILITY; PYLARIFY AI™ PYLARIFY AI™ Overview; What Is PYLARIFY AI™? PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. S. 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. 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. 6% and an increase of 25. 18F-DCFPyL is now the first. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes. 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. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. 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. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Phone: 1-800-964-0446. NEW YORK, Feb. PET/CT. 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’. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 99 for the third quarter of 2022, representing an increase of approximately $0. Lastly, net cash provided by operating activities was $116. US Customer Service/Order PYLARIFY®. 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. In June, Lantheus announced that it has demonstrated the higher efficiency and consistency of the Pylarify AI platform while maintaining the diagnostic accuracy of Prostate-Specific Membrane. . The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. BEDFORD, Mass. NORTH BILLERICA, Mass. North Billerica, MA: Progenics Pharmaceuticals, Inc. With 3 million men living with prostate cancer and more than 18. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). 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 Announces Presentations Featuring PYLARIFY AI at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12, 2023 BEDFORD, Mass. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. , Sept. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. This is an increase of 200% compared to the previous 30 days. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. and EXINI Diagnostics AB. INDICATION. 47, as compared to $0. INDICATION. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. 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. Third quarter operating cash. The Company’s second quarter 2022 GAAP net income was $43. to 6:00 p. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the. Melissa Downs Senior Director, Corporate Communications 646. 5 million for the first quarter 2023. The company also received a CE marking in Europe for PYLARIFY AI. June 12,. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud to. For men with prostate cancer,. LNTH earnings call for the period ending June 30, 2021. and EXINI Diagnostics AB. Our products have practical applications in oncology, cardiology and more. Sanchez-Crespo A. , VP, Medical Affairs E. 37. 4% from the prior year period. Syntermed announces its appointment by Lantheus Holdings, Inc. 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. , [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. Lastly, net cash provided by operating activities was $108. 5 million, representing 61. PDF Version. S. S. In the U. com. 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. with suspected recurrence based on. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 96 and $0. 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. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 33 for the second quarter 2023, compared. 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. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 6 million worth of sales while DEFINITY contributed $63. Lantheus Holdings, Inc. com. (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. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 2 million for the third quarter 2022, compared to GAAP net loss of $13. Progenics Pharmaceuticals, Inc. , [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. S. November 29, 2021 08:30 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. Billerica, MA 01862 . 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. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. 0 million and $150. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. 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. S. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. 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 delivered another strong quarter and full year, highlighted by revenue performance which increased 38% and 25%, respectively,” said Mary Anne Heino, President and CEO. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 9% Sodium Chloride Injection, USP. Lantheus Receives U. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. Worldwide revenue of $300. 2 million for the fourth quarter and full year 2021, representing an increase of 37. PYLARIFY® may help detect metastases even when PSA levels are low. March 29, 2022 at 8:00 AM · 8 min read. 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. 28 May, 2021, 07:00 ET. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 men with either high-risk prostate cancer (Cohort A; n=268) or radiologic evidence of recurrence (Cohort B; n=117) OSPREY assessed the sensitivity, specificity, PPV, and NPV in pelvic lymph nodes for PYLARIFY® PET/CT. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. In the U. , Progenics Pharmaceuticals, Inc. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. • Dispose of any unused PYLARIFY in compliance with applicable regulations. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. In the U. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. 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. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to.