The company's. with suspected recurrence based on. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. 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. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. TechneLite net revenue was $24. 5 million for the first quarter 2023. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 9% Sodium Chloride Injection, USP. 1 million for the third quarter 2021, representing an increase of 15. The merger agreement was first announced on October 2, 2019 . 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. 47, as compared to $0. For men with prostate cancer,. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. US Customer Service/Order PYLARIFY®. com. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. This sample claim form is only an example. Melissa Downs Senior Director, Corporate Communications 646-975-2533 media@lantheus. 7 million for the second quarter 2022, representing an increase of 121. 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. (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. , Progenics Pharmaceuticals, Inc. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud to. 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. “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. PYLARIFY® (piflufolastat F 18) Injection Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. 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. 3. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 47, as compared to $0. , Nov. 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. Pylarify is the largest growth driver for the company as it comprised 65% of. PYLARIFY Injection is designed to detect prostate-specific membrane. (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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 3M as the prostate cancer diagnostic agent Pylarify added $143. 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. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. 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,. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. INDICATION. S. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Follow. D. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. , CEO of POINT Biopharma. S. com. 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. This agent is similar to the Gallium-68 PSMA-11 agent which was approved in December 2020, except that it can be produced in much greater quantities and distrMarketBeat has tracked 5 news articles for Lantheus this week, compared to 5 articles on an average week. Image source: The Motley Fool. NORTH BILLERICA,. S. PRODUCT NAME: PYLARIFY (piflufolastat F18) injection CAS Number: 1423758-00-2 Product Uses: diagnostic radiopharmaceutical COMPANY. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 0 million and $150. 99 for the third quarter of 2022, representing an increase of approximately $0. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. 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. com. Lantheus' Key Products Driving Growth. PDF Version. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. TechneLite net revenue was $24. In the U. “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. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. Pylarify. 0. Lantheus Holdings, Inc. 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. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. 97 for the first quarter of 2022, representing an increase of approximately $0. North Billerica, MA: Progenics Pharmaceuticals, Inc. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. , 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. • Visually inspect the radiopharmaceutical solution. Develop and deploy marketing strategies to drive ROI, sales and margin. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. S. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. 1 million for the second quarter 2022, compared to GAAP net loss of $26. 45 and $0. PYLARIFY (piflufolastat F18) injection. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Lantheus expects their fully diluted adjusted earnings per share to be between $0. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). June 12, 2023 at 8:30 AM EDT. ET. is the parent company of Lantheus Medical Imaging, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. D. 54, as compared to $0. Jul 28, 2021, 8:00 a. GAAP fully diluted earnings per share were $1. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Product Uses: diagnostic radiopharmaceutical . The results. Nov 2014 - Sep 2017 2 years 11 months. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. (the “Company”) (NASDAQ: LNTH), an established leader and fully. Our products have practical applications in oncology, cardiology and more. 2% for the week as of Friday afternoon,. 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. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. Lantheus Receives U. S. S. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. Lantheus Receives U. Accessed May 11, 2022. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact 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. “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. 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. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. February 16, 2023 at 8:30 AM EST. 8 billion tied up in biobucks. June 12, 2023 08:30 ET | Source: Lantheus Holdings. PYLARIFY® is an imaging agent for PET/CT scans that uses a unique combination of a PSMA-targeted small molecule and the radioactive tracer 18 F to help your doctor make more informed treatment choices based on clear images. 7 million for the third quarter 2023. 96 and $0. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. . This page is intended to serve as notice under 35 U. Lantheus Holdings, Inc. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. S. 7 million in the same period last year. Coordination of care. 7 million is being distributed to the holders. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 6 million worth of sales while DEFINITY contributed $63. The following U. 7 million, up 12. D. The program is available to HCPs who have completed the PYLARIFY® Reader Training. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. , Sept. m. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. Morris MJ, Rowe SP, Gorin MA, et al. 3. For men with prostate cancer, PYLARIFY. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. com. Developed by Lantheus, PYLARIFY ® was recently approved by the U. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. 2 million, compared with $129. 9 million for the first quarter 2022, representing an increase of 125. Lantheus provides a broad portfolio of products, including PYLARIFY. 9 mg ethanol in 0. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. Worldwide revenue of $300. Worldwide revenue of $129. 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. , Progenics Pharmaceuticals, Inc. But most. We accelerated our growth. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. CAS Number: 1423758-00-2. 54. “The transaction leverages 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. (NASDAQ:NASDAQ:LNTH) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ETCompany ParticipantsMary Anne Heino – President and Chief Executive Officer Mark. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. with suspected recurrence based on. is the parent company of Lantheus Medical Imaging, Inc. 8% from the prior year period; GAAP net income of $94. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. --(BUSINESS WIRE)--Dec. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis. 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. 25 reported a year ago. • Dispose of any unused PYLARIFY in compliance with applicable regulations. 9 million, up 33. Lantheus Reports Second Quarter 2023 Financial Results. NORTH BILLERICA, Mass. Deploy. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . , a Lantheus company. Worldwide revenue of $239. Mid-cap Lantheus Holdings has been on a revenue growth spurt boosted by a new product called Pylarify, which helps detect prostate cancer in an imaging test. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. PYLARIFY was approved by the U. 50 from the prior year period. S. Contact information For media. 66 from the prior year period. PYLARIFY identifies PSMA, the. 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. com. “This. November 3, 2022 at 7:00 AM · 11 min read. Lantheus Announces Presentations Featuring PYLARIFY AI at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12, 2023 BEDFORD, Mass. 5 million for the first quarter 2023. 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. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 7% year-over-year, and progressed our. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. , Nov. 1 million for the fourth quarter and full year 2022, representing increases of 103. C. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 61 for the second quarter. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. NORTH BILLERICA, Mass. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. 7 million, up 12. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. Lantheus Holdings, Inc. PYLARIFY (piflufolastat F18) injection. 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. 37. U. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. This other product, even though it was, I'll say, riding the wave of the momentum that. An FDA-cleared medical device software, PYLARIFY AI V1. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. and EXINI Diagnostics AB. The Lantheus Protocol: Pylarify Growth May Slow. 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. 2021 was a year of significant achievements for Lantheus. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). Under a commercial supply agreement with Lantheus, SOFIE will roll out PYLARIFY via its national network, which has manufactured numerous PYLARIFY doses for Lantheus during the clinical trials. 00. 99 for the third quarter of 2022, representing an increase of approximately $0. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. 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. , Nov. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. Leadership provided initial guidance for FY2023 as well. The company reports earnings on November 3, with analysts expecting the company to top last year's results. , Nov. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Billerica, MA 01862 . 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. 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. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. • Assay the dose in a suitable dose calibrator prior to administration. 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. 3% over the prior year. 4. Lastly, net cash provided by operating activities was $108. 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 AI is an FDA-cleared medical device software and is commercially available in the United States. m. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. (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. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. 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 has offices in Massachusetts, New Jersey, Canada and Sweden. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 [email protected] has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. PYLARIFY is the only PSMA-imaging agent that is widely available through a diverse, multi-partner F18 distributor network, ensuring convenient and reliable supply MARKET ACCESS More than 90% of covered lives have access to PSMA PET with PYLARIFY1 UTILIZATION PYLARIFY is the #1 ordered PSMA PET imaging agent in the U. Pylarify accounted for $160. United States of America . 331 Treble Cove Road . 2% from the prior year quarter due to. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. This sample claim form is only an example. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Pylarify is the largest growth driver for the company as it comprised 65% of. 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. 0% from the prior year period. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. Worldwide revenue of $321. 52%) were up 21. S. GAAP. 4 million. com. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. Lantheus Holdings. 1 million for the third quarter of 2021, representing an increase of 134. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 8% from the prior year period. SOFIE’s Vice President of Sales & Marketing, Mike Parisi, states, “We are thrilled to partner with Lantheus to commercially supply this new and. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. [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. But most. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. Lantheus Holdings, Inc. , a Lantheus company. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. 3% over the prior year. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. S. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. 37, while. 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. S. m. BEDFORD, Mass. 2 million, or $0. LNTH-1095 (also known as MIP-1095) is a small molecule PSMA-targeted 131 I-based radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) which combines a PSMA-targeted ligand, LNTH-1095, with the beta-emitting radioisotope 131 I. 6 million to the ante. Melissa Downs Senior Director, Corporate Communications 646. 0% from the prior year period. PYLARIFY® [package insert]. Today, we put the spotlight on Lantheus Holdings for the first time. 47, as compared to $0. Lantheus Holdings, Inc. 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. 01. 28 May, 2021, 07:00 ET. , Progenics Pharmaceuticals, Inc. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. Progenics Pharmaceuticals, Inc. S. Lantheus Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. NORTH BILLERICA, Mass. Worldwide revenue of $239. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. We reported revenue of $319. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. In the last reported quarter, Lantheus earnings per share (EPS) of $1. The creation of artificial high-performance photosynthetic assemblies with a tailorable antenna system to deliver absorbed solar energy to a photosynthetic reaction center,. 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. 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. Worldwide revenue of $208. Under. 36%) Q3 2021 Earnings Call. 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 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. 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. m. Shares of Lantheus Holdings (LNTH-0. Purpose of this notice. 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. 0 million and $150. 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. 1% over the. Contacts: Mark Kinarney Vice President, Investor Relations978-671-8842 [email protected] will provide further details on the PYLARIFY launch to date in a few minutes, but I am thrilled that less than one year after we commenced our launch, more than 30,000 men have been imaged. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors. Since then, Lantheus' sales have more than doubled. (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. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. , Nov. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. 47, as compared to $0. 2. . disease. 9% over the prior year periods. S. Lantheus Holdings’ Pylarify injection is a fluorinated small molecule PSMA-targeted PET imaging agent that allows for the visualization of lymph nodes, bone and soft tissue. com. • Assay the dose in a suitable dose calibrator prior to administration. 50. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. Director, Corporate Communications. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. Third quarter operating cash. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. 0.