1% over the. NORTH BILLERICA, Mass. Billerica, MA 01862 . 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. 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. Welcome to the Lantheus Third Quarter 2023 Financial Results. Lantheus Holdings, Inc. The following U. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the. For men with prostate cancer,. , Sept. S. 7 million for the second quarter 2022, representing an increase of 121. (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. We accelerated our growth. 3 million for the second quarter 2023. PDF Version. For International Transportation. Our products have practical applications in oncology, cardiology and more. But. Today, we put the spotlight on Lantheus Holdings for the first time. This sample claim form is only an example. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. In the U. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. 0. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. Residents Only. and EXINI Diagnostics AB. 2% from the prior year quarter due to. • Assay the dose in a suitable dose calibrator prior to administration. Pylarify is the largest growth driver for the company as it comprised 65% of. The creation of artificial high-performance photosynthetic assemblies with a tailorable antenna system to deliver absorbed solar energy to a photosynthetic reaction center,. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 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; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. All rights reserved. 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. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. We reported revenue of $319. U. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. Lantheus Holdings, Inc. 52%) were up 21. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. North Billerica, MA: Progenics Pharmaceuticals, Inc. Worldwide revenue of $300. 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 Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. Lantheus Holdings, Inc. 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. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. In the U. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). PYLARIFY may be diluted with 0. GAAP net. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Develop and deploy marketing strategies to drive ROI, sales and margin. S. • Dispose of any unused PYLARIFY in compliance with applicable regulations. 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. 3% from the prior year period. Greater Chicago Area. Heino , President and Chief Executive Officer of Lantheus . Third quarter operating cash. Morris MJ, Rowe SP, Gorin MA, et al. Strategic architect for the Uro-oncology franchise. Worldwide revenue of $239. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect 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. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. 33 for the second quarter 2023, compared. Lantheus Medical Imaging has received approval from the U. 7 million for the second quarter 2023, representing an increase of 43. 6 million to the ante. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. 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. Lantheus Holdings, Inc. 99 for the third quarter of 2022, representing an increase of approximately $0. 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. Find out why LNTH stock is a Strong Buy. D. 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. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. S. 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. February 16, 2023 at 8:30 AM EST. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. GAAP. 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. (“the Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. 1% over the. Contact information For media. 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. Mark Kinarney. 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. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly availableLantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. 1M in 2022, following a 25% YoY decline, according to the. . 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. Food and Drug Administration (FDA) has approved. “Being selected by Lantheus to partner to administer the first dose of PYLARIFY is an honor, and it’s humbling to know that GenesisCare will be potentially helping men with prostate cancer, while improving access to high-quality care for our patients. com. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. Our products have practical applications in oncology, cardiology and more. 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. Lantheus Receives U. But most. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. PYLARIFY® (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. , Nov. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. (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. NORTH BILLERICA, Mass. Eastern Time. “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. 8 million for the first quarter 2023, representing an increase of 44. 8 billion tied up in biobucks. S. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. NORTH BILLERICA, Mass. 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. S. NORTH BILLERICA,. 9, 2020-- Lantheus Holdings, Inc. , Progenics Pharmaceuticals, Inc. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. patents apply to our products: DEFINITY ® /DEFINITY. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. But most. Fax: 978-436-7296. 6 million worth of sales while DEFINITY contributed $63. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. 25 reported a year ago. In the U. PYLARIFY AI deployment can be facilitated both as a secure web cloud application and as a local. Coordination of care. Pylarify is labeled with F-18 and homes in on PSMA, a protein that is overexpressed on the surface of more than 90% of. Product Uses . Shares of Lantheus Holdings (LNTH-0. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. , [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. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. Assay the dose in a suitable dose calibrator prior to administration. 0. Senior Director, Investor Relations. In the U. 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. 3. PDF Version. Progenics Pharmaceuticals, Inc. Lantheus Holdings, Inc. prostate cancer community and are likely to have contributed to the top. 2% from the prior year quarter due to. United States of America . disease. 1 million for the second quarter 2022, compared to GAAP net loss of $26. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 3 million for the third quarter 2022, representing an increase of 134. 3M as the prostate cancer diagnostic agent Pylarify added $143. ,. With 3 million men living with prostate cancer and more than 18 million adults. Melissa Downs Senior Director, Corporate Communications 646. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. m. S. 0 million and $150. Lantheus Holdings, Inc. “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. US Customer Service/Order PYLARIFY®. 7 million, up 12. 99 for the third quarter of 2022, representing an increase of approximately $0. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 646-975-2533. , [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 With more than 65 years of experience in delivering life. 9% Sodium Chloride Injection USP. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. BEDFORD, Mass. 7 million for the third quarter 2023. Now turning to cash flow. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. S. Eastern, Monday - Friday © 2023 Lantheus. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Worldwide revenue of $208. 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. 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. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. Lantheus’ product, PYLARIFY ® (piflufolastat F 18) injection, is a radioactive diagnostic agent indicated for PET imaging of PSMA positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and/or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. commercial products, particularly PYLARIFY and DEFINITY, in the face of competition; (ii) our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house. 4. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. 2 million for the fourth quarter and full year 2021, representing an increase of 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. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Product Uses . Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. 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. S. m. Phone: 1-800-964-0446. 9% Sodium Chloride Injection, USP. 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 . Minimum 15 minutes delayed. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. Purpose of this notice. SOFIE’s Vice President of Sales & Marketing, Mike Parisi, states, “We are thrilled to partner with Lantheus to commercially supply this new and. com. , Nov. as the first U. 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 data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. BEDFORD, Mass. This page is intended to serve as notice under 35 U. BEDFORD, Mass. 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. Shares of Lantheus Holdings (LNTH-0. and Progenics Pharmaceuticals, Inc. Worldwide revenue of $239. Lantheus Holdings, Inc. Jul 28, 2021, 8:00 a. 2 million, compared with $129. PYLARIFY seems to be affected by the amount (level) of PSA in your blood. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. Lantheus Receives U. 2. 28 May, 2021, 07:00 ET. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 1 million, or $0. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 7 million for the second quarter 2023, representing an increase of 43. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. This is an increase of 200% compared to the previous 30 days. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. com. is the parent company of Lantheus Medical Imaging, Inc. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. m. Eastern Time. Lantheus Holdings, Inc ( LNTH 0. 89 for the second quarter of 2022, representing an increase of approximately $0. com. com. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. 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. S. This is the first and final payment related to the CVRs and is in full satisfaction of Lantheus’ payment obligations related to the CVRs. Lantheus provides a broad portfolio of products, including PYLARIFY. Melissa Downs Senior Director, Corporate Communications 646. S. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. April 29, 2022 07:07 ET | Source: Lantheus Holdings, Inc. Nov 6, 2021, 2:00 p. Customer Service: 1-800-299-3431: Hours: 7:30 a. Billerica, MA 01862 . This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. 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. 01. is the parent company of Lantheus Medical Imaging, 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 PYLARIFY AI data will be presented at the. 37, surpassing the consensus of $0. . 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. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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. S. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. , Sept. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. §287(a). Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. 1-800-299-3431. In the U. diagnostic radiopharmaceutical. Leadership provided initial guidance for FY2023 as well. Sanchez-Crespo A. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA). 5 million, representing 61. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 47, as compared to $0. Accessed May 11, 2022. PYLARIFY (piflufolastat F18) injection . “This. 1-800-299-3431. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. 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. S. “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. An FDA-cleared medical device software, PYLARIFY AI V1. BEDFORD, Mass. 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. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. With 3 million men living with prostate cancer and more than 18. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. 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. 2% for the week as of Friday afternoon,. • Dispose of any unused PYLARIFY in compliance with applicable regulations. 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. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. PYLARIFY is a. 3 million for the third quarter 2022, representing an increase of 134. 2 million, or $0. 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. com. The device provides general. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. , CEO of POINT Biopharma. Read more about Lantheus Announces Top Rated Oral Presentation. 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. D. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. June 12,. 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. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. • Assay the dose in a suitable dose calibrator prior to administration. TechneLite net revenue was $24. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. 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. 9 million for the first quarter 2022, representing an increase of 125. Based in North Billerica, Mass. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. Syntermed announces its appointment by Lantheus Holdings, Inc. NEW YORK, Jan. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. 1 million for the fourth quarter and full year 2022, representing increases of 103. 2 million, compared with $129. PYLARIFY may be diluted with 0. In. LNTH is expected to report second-quarter 2022 results on Jul 27. , Progenics Pharmaceuticals, Inc. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. INDICATION. , a Lantheus company . DULLES, Va. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. 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 Holdings, Inc. com. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. Lastly, net cash provided by operating activities was $108. 37, while. 4% from the prior year period. Lantheus Holdings Inc. “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. 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. , Progenics Pharmaceuticals, Inc. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 3 million, compared with $102. , Nov. 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. NORTH BILLERICA,. Lantheus Holdings, Inc. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions.