But. 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. SOFIE’s Vice President of Sales & Marketing, Mike Parisi, states, “We are thrilled to partner with Lantheus to commercially supply this new and. The following U. 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. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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 has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. S. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. 8 million for the first quarter 2023, representing an increase of 44. is the parent company of Lantheus Medical Imaging, Inc. 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 Holdings, Inc. , 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. 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. 5 million, representing 61. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. “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. 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. 8% from the prior year period. Published online May 11, 2022. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). S. This sample claim form is only an example. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. Jul 21, 2022 02:13PM EDT. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. PYLARIFY (piflufolastat F 18) injection (also known as 18 F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. S. PYLARIFY may be diluted with 0. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. November 3, 2022 at 7:00 AM · 11 min read. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. com. 6 million worth of sales while DEFINITY contributed $63. About Lantheus With more than 65 years of experience in delivering life. 25 reported a year ago. INDICATION. S. Worldwide revenue of $102. diagnostic radiopharmaceutical. 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® may help detect metastases even when PSA levels are low. Lantheus Holdings, Inc. NORTH BILLERICA, Mass. S. US Customer Service/Order PYLARIFY®. diagnostic radiopharmaceutical. 9 mg ethanol in 0. 54, as compared to $0. PDF. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. NORTH BILLERICA, Mass. Worldwide revenue of $263. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 9 mg ethanol in 0. S. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 6% and an increase of 25. 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. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 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. The program is available to HCPs who have completed the PYLARIFY® Reader Training. and Progenics Pharmaceuticals, Inc. This is an increase of 200% compared to the previous 30 days. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. NORTH BILLERICA, Mass. NORTH BILLERICA, Mass. 4. The Company’s third quarter 2022 GAAP net income was $61. Lantheus Receives U. • Calculate the necessary volume to administer based on calibration time and required dose. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. S. Intended for U. 7 million, up 12. 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. June 12,. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. 61 for the second quarter. 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:. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. It will need to spend additional. 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. PYLARIFY may be diluted with 0. Q4 adjuested EPS grew +448% Y/Y to $1. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. 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. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. PDF Version. NEW YORK, Jan. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. 48 from the prior year period. D. In the U. 4% from the prior year period; GAAP net income of $43. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. 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 Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. [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. NORTH BILLERICA, Mass. 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. (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. In the U. 47, as compared to $0. Customer Service: 1-800-299-3431: Hours: 7:30 a. But most. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. 1 million for the third quarter 2021, representing an increase of 15. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. 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. Developed by Lantheus, PYLARIFY ® was recently approved by the U. , Nov. 5 million for the first quarter 2023. 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. 4 million in revenue, up 25% year over year, and a net loss of $11. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify. Assay the dose in a suitable dose calibrator prior to administration. 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. $ 68. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. June 12, 2023 08:30 ET | Source: Lantheus Holdings. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Worldwide revenue of $239. 8M of net sales while cardiovascular ultrasound enhancement. , Nov. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. While the company generated $527M in. 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. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. March 29, 2022 at 8:00 AM · 8 min read. 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. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. S. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. 3% over the prior. 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. com. (RTTNews) - 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® FOR PCa IMAGING; EFFICACY AND SAFETY. “This. S. , Sept. D. The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. May 4, 2023 at 7:00 AM · 10 min read. For International Transportation. This was another terrific quarter for 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. 1 million for the second quarter 2023, compared to GAAP net income of $43. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 7 million, compared with $101. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. 1 million for the fourth quarter and full year 2022, representing increases of 103. About Lantheus With more than 65 years of experience in delivering life. The company reports earnings on November 3, with analysts expecting the company to top last year's results. , a Lantheus company. ,. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Lastly, net cash used in operating activities was $32. In the U. The FDA just recently approved the PSMA (piflfolastat F 18) scan. disease. Pylarify is the largest growth driver for the company as it comprised 65% of. 1% and 119. Worldwide revenue of $321. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. NORTH BILLERICA, Mass. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. The merger agreement was first announced on October 2, 2019 . Pylarify. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 89 for the second quarter of 2022, representing an increase of approximately $0. GAAP net loss. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. In the U. 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. NORTH BILLERICA,. 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”). 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. GAAP. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. Lantheus Holdings, Inc. 5 million, representing 61. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 00. , [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. 50. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. INDICATION. by year. with suspected recurrence based on. Follow the PYLARIFY® injection with an intravenous flush of 0. Billerica, MA 01862 . Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. The company's. 47, as compared to $0. “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 Holdings. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Lantheus Holdings, Inc. “PYLARIFY AI is the first and only FDA-cleared medical device software that offers a standardized platform for quantifying PSMA PET/CT images,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. 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 received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. 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. LNTH earnings call for the period ending June 30, 2021. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. “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. 17%. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. 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. 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. Worldwide revenue of $300. Lantheus Holdings, Inc. GAAP fully diluted earnings per share were $1. D. The device provides general. 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. 3 million for the second quarter 2023. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. U. 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. U. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. 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. 1. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. 66 from the prior year period. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. Follow the PYLARIFY® injection with an intravenous flush of 0. Please refer to the map below for the production site nearest you. 8 million, compared to a loss of $21. 88 and earnings of $1. Lantheus Reports Second Quarter 2023 Financial Results. 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 Pylarify AI system is a deep learning algorithm that allows physicians to. All rights reserved. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. LinkedIn. 9% Sodium Chloride Injection USP. 2% for the week as of Friday afternoon,. 0. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. §287(a). Greater Chicago Area. S. GAAP net. • Assay the dose in a suitable dose calibrator prior to administration. PDF Version. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 31 Mar, 2022, 09:00 ET. m. patents apply to our products: DEFINITY ® /DEFINITY. February 16, 2023 at 8:30 AM EST. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , 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. PYLARIFY AI™ (aPROMISE) is the only deep learning enabled FDA-cleared medical device software to offer standardized PSMA PET reporting on PSMA PET/CT images, including those achieved using. 1 million, or $0. S. 1% over the. PYLARIFY works with PET/CT technology to produce a combined PET/CT scan that enables the reader of the PET/CT scan to detect and locate the disease. and EXINI Diagnostics AB and anWorldwide revenue of $223. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. 2 million for the third quarter 2022, compared to GAAP net loss of $13. PYLARIFY® [package insert]. 2% from the prior year quarter due to. Lantheus Receives U. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. February 10, 2022 17:33 ET | Source: Lantheus Holdings, Inc. 0. , Nov. His confidence is backed by Lantheus’s Q3 results which exceeded Street expectations, largely due to the continued strength of their product, Pylarify, and their Precision Diagnostics segment. m. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 33 for the second quarter 2023, compared. 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. 97 for the first quarter of 2022, representing an increase of approximately $0. Lantheus spent months preparing for PYLARIFY's launch and has scaled up the company's commercial, medical, and manufacturing capabilities to ensure the launch is successful. 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 Injection is designed to detect prostate-specific membrane. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. PYLARIFY Injection is designed to detect prostate-specific membrane. 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. 12. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. The Lantheus Protocol: Pylarify Growth May Slow. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. 3 million for the third quarter 2022, representing an increase of 134. Our products have practical applications in oncology, cardiology and more. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 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. Product Uses: diagnostic radiopharmaceutical . This other product, even though it was, I'll say, riding the wave of the momentum that. 7 million for the second quarter 2023, representing an increase of 43. 4% from the prior year period. . 3 million for the third quarter 2022, representing an increase of 134. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. PYLARIFY, approved by the FDA in May 2021, is the first commercially and widely available prostate-specific membrane antigen (PSMA) PET imaging agent. Purpose of this notice. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. "There are several, and there will be new ones down the. 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. Residents Only. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. TechneLite net revenue was $24. Lantheus expects their fully diluted adjusted earnings per share to be between $0. 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 a.