S. 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. 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. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. BEDFORD, Mass. 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:. , Nov. PYLARIFY (piflufolastat F18) injection . 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; PYLARIFY AI™, an artificial intelligence platform that assists in the. May 27, 2021 — Today, the FDA approved the 18F-DCFPyL PSMA PET imaging agent (also known as “PyL” for short or by its trade name “PYLARIFY”). S. 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. Intended for U. February 10, 2022 17:33 ET | Source: Lantheus Holdings, Inc. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. , Sept. 4% from the prior year period; GAAP net income of $43. “In addition to FDA approval, inclusion in the guidelines. 9% Sodium Chloride Injection, USP. 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. , Progenics Pharmaceuticals, Inc. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. The FDA just recently approved the PSMA (piflfolastat F 18) scan. In the U. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 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. 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; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. 2 million and $935. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. The company expects to. Lantheus says its technology can help improve the management of prostate cancer patients. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. Lantheus Holdings, Inc. NORTH BILLERICA, Mass. 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. 4. June 12,. For men with prostate cancer, PYLARIFY. 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. 8 billion tied up in biobucks. For International Transportation Emergencies Call CC-BY-4. The creation of artificial high-performance photosynthetic assemblies with a tailorable antenna system to deliver absorbed solar energy to a photosynthetic reaction center,. PYLARIFY Injection is designed to detect prostate-specific membrane. 1. US Customer Service/Order PYLARIFY®. But most. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. , [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 Holdings, Inc. , Sept. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. S. 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. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. §287(a). The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. --(BUSINESS WIRE)--Dec. m. 97 for the first quarter of 2022, representing an increase of approximately $0. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. May 4, 2023 at 7:00 AM · 10 min read. NORTH BILLERICA, Mass. Pylarify is the largest growth driver for the company as it comprised 65% of. “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. 7 million for the third quarter 2023. S. Published online May 11, 2022. 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. PYLARIFY is a. S. Lantheus Holdings, Inc. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. 9, 2020-- Lantheus Holdings, Inc. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. (the Company) (NASDAQ: LNTH), a company committed to“Lantheus is a demonstrated commercial leader in the field of radiopharmaceuticals. 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. and EXINI Diagnostics AB. ,. PYLARIFY PSMA - Where and when. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. The stock has been a big winner in 2022 thanks to the impressive growth racked up by recently launched imaging agent Pylarify. 1 million for the third quarter of 2021, representing an increase of 134. Assay the dose in a suitable dose calibrator prior to administration. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. 9% over the prior year periods. 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. S. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. Lantheus Holdings, Inc. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 1-800-299-3431. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 0 million and $150. Lantheus Holdings, Inc. 9 mg ethanol in 0. UAB Therapy Intensive Program – for Technologists. 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™ (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. TechneLite net revenue was $24. 2023 Annual Scan Potential Estimates 12. It will need to spend additional. 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. 1% and 119. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. S. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. The company reports earnings on November 3, with analysts expecting the company to top last year's results. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 0 is commercially available in the United States . 7% year-over-year, and progressed our. 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. 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. 1M in 2022, following a 25% YoY decline, according to the. to 6:00 p. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. 8% from the prior year period. PYLARIFY –Prostate Cancer Franchise Overview Paul Blanchfield, Chief Commercial Officer Etienne Montagut, Chief Business Officer Aseem Anand, VP of Digital Solutions PYLARIFY Key Opinion Leader Panel Moderator: Bela Denes, M. PYLARIFY may be diluted with 0. Image source: The Motley Fool. BEDFORD, Mass. is the parent company of Lantheus Medical Imaging, Inc. 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. 3. LNTH is expected to report second-quarter 2022 results on Jul 27. Our products have practical applications in oncology, cardiology and more. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. , a Lantheus company . "It's not like there is only one PSMA molecule that we can radiolabel," said Cameron Foster, director of theranostics at the University of California, Davis. Lantheus Original Approval date: May 26, 2021. D. (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. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. David Crawford, M. United States of America . “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. 4% from the prior year period. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. BEDFORD, Mass. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. With 3 million men living with prostate cancer and more than 18. Lantheus expects their fully diluted adjusted earnings per share to be between $0. 50. 9 million, up 33. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. Under. 4% from the prior year period ; GAAP net income of $61. Melissa Downs Senior Director, Corporate Communications 646-975-2533 media@lantheus. 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. Lantheus Holdings Inc (NASDAQ:LNTH) made significant progress during the quarter with PYLARIFY and DEFINITY in its commercial portfolio, and with PNT2002 and MK-6240 in its pipeline. Shares of Lantheus Holdings (LNTH-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. The program is available to HCPs who have completed the PYLARIFY® Reader Training. S. Mark Kinarney. 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. The results. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). 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. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. 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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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 Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 1 million for the fourth quarter and full year 2022, representing increases of 103. This page is intended to serve as notice under 35 U. About Lantheus With more than 65 years of experience in delivering life. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. 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,. 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. GAAP. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. Food and Drug Administration (FDA) has approved. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. 33 for the second quarter 2023, compared. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. Worldwide revenue of $300. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. November 3, 2022 at 7:00 AM · 11 min read. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Jul. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus Holdings, Inc ( LNTH 0. 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. Fax: 978-436-7296. S. Food and Drug Administration in May 2021. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . 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. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. 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. 9% Sodium Chloride Injection, USP. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 01. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. “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. 61 per fully diluted share, as compared to GAAP net loss. Read More. Jul 21, 2022 02:13PM EDT. GAAP fully diluted earnings per share were $1. INDICATION. On-site plant will produce. 1 million for the second quarter of 2021, representing an increase of 121. Product Uses . We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. 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. 5 million for the first quarter 2023. Purpose of this notice. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. In the U. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. Follow the PYLARIFY® injection with an intravenous flush of 0. Coordination of care. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform the way that clinicians manage and treat prostate cancer,” said Jean-Claude Provost, MD, Interim Chief Medical Officer, Lantheus. Eastern, Monday - Friday © 2023 Lantheus. $ 68. PET/CT. February 16, 2023 at 8:30 AM EST. NORTH BILLERICA, Mass. , Nov. istering PYLARIFY. Lantheus Receives U. 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. Assay the dose in a suitable dose calibrator prior to administration. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. 331 Treble Cove Road . with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 86 for the third quarter 2022, compared to. 2% for the week as of Friday afternoon,. Worldwide revenue of $239. with suspected recurrence based on. 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. LinkedIn. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm ET, or email [email protected] Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Director, Corporate Communications. 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. S. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. The Company updates its guidance for the first quarter and full year 2023 is as follows: PYLARIFY revenues in 1H23 were $405m - up 82% year-on-year - so it seems clear that PYLARIFY revenues have substantially more growth potential - Lantheus' guidance for total revenues in 2023. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Lantheus Holdings. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify. PYLARIFY Injection is designed to detect prostate-specific membrane. But. 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. About Lantheus With more than 65 years of experience in delivering life. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. Our products have practical applications in oncology, cardiology and more. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. is the parent company of Lantheus Medical Imaging, Inc. 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; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. Lastly, net cash used in operating activities was $32. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 50 from the prior year period. and EXINI Diagnostics AB and anWorldwide revenue of $223. NEW YORK, Jan. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. 3 million for the third quarter 2022, representing an increase of 134. The program is available to HCPs who have completed the PYLARIFY® Reader Training. Heino , President and Chief Executive Officer of Lantheus . , a Lantheus company . . 7 million for the second quarter 2022, representing an increase of 121. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. 89 for the second quarter of 2022, representing an increase of approximately $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. TechneLite net revenue was $24. “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. S. The device provides general. 3% over the prior. US Customer Service/Order PYLARIFY®. PYLARIFY may be diluted with 0. The following U. , CEO of POINT Biopharma. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. Visit Investor Site. 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. 6 million worth of sales while DEFINITY contributed $63. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. 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. , Progenics Pharmaceuticals, Inc. 3. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. PYLARIFY works by binding to PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. 3% over the prior year. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. Lantheus Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. S. Contact information For media. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. 01. In the last reported quarter, Lantheus earnings per share (EPS) of $1. 3 million for the second quarter 2023. “Today marks an important day for Lantheus and Progenics. Eastern Time. PYLARIFY was approved by the U. , [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. 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. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. 9% sodium chloride injection USP. This is an increase of 200% compared to the previous 30 days. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. An FDA-cleared medical device software, PYLARIFY AI V1. BEDFORD, Mass. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. 12. 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. 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. , [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 provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 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. 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. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. --(BUSINESS WIRE)--May 27, 2021-- Lantheus Holdings, Inc. NORTH BILLERICA, Mass. • Assay the dose in a suitable dose calibrator prior to administration. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 331 Treble Cove Road . 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. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. Worldwide revenue of $263. This sample claim form is only an example. 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. com. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. Lastly, net cash provided by operating activities was $116. S. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. 3 million, compared with $102. Lantheus Receives U. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. The Company’s second quarter 2022 GAAP net income was $43. 17%. CC-BY-4. 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. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). GAAP net loss. CAS Number: 1423758-00-2. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth.