47, as compared to $0. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. All rights reserved. 01. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. “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. 89 for the second quarter of 2022, representing an increase of approximately $0. Progenics Pharmaceuticals, Inc. 4 million. Worldwide revenue of $300. 1% over the. 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. 5 million for the first quarter 2023. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. 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. DEFINITY in our in-house manufacturing facility; (v) our ability to successfully launch PYLARIFY AI as a commercial product; (vi) the continuing impact of the global COVID-19 pandemic on our business, supplyPhysicians and staff can use this resource to streamline access and reimbursement for PYLARIFY® (piflufolastat F 18) injection for appropriate patients. The company reported Q4 adjusted EPS of $1. 0 million and $150. United States of America . Lantheus Holdings, Inc. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. GAAP fully diluted earnings per share were $1. 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. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023, with the vast majority of our sequential growth driven by our existing accounts. 0. Pylarify is labeled with F-18 and homes in on PSMA, a protein that is overexpressed on the surface of more than 90% of. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. May 16, 2022 at 8:00 AM EDT. 6% and an increase of 25. BEDFORD, Mass. , 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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. 9% over the prior year periods. NORTH BILLERICA, Mass. In the U. Lantheus Holdings, inc ( LNTH 2. North Billerica, MA: Progenics Pharmaceuticals, Inc. 54, as compared to $0. 5 million, representing 61. com. 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. 2 million for the third quarter 2022, compared to GAAP net loss of $13. 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. 0 is commercially available in the United States . • Visually inspect the radiopharmaceutical solution. (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. 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 available68. by year. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. is the parent company of Lantheus Medical Imaging, Inc. and EXINI Diagnostics AB and anWorldwide revenue of $223. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. In the U. The following U. This indicates a strong confidence in Pylarify’s growth, even amidst new. 15. 48 from the prior year period. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of 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. Product Uses: diagnostic radiopharmaceutical . Melissa Downs Senior Director, Corporate Communications 646. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. S. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. , a Lantheus company. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. Lantheus Holdings, Inc. “PYLARIFY has the potential to contribute meaningful and actionable information that can be used to personalize treatment plans in men with low PSA levels,” said Dr. BEDFORD, Mass. 肿瘤学放射性药物 （帮助医疗保健专业人员发现、治疗和跟踪癌症的诊断和治疗方法）： ·PYLARIFY（也被称为Piflufolastat F-18、18F-DCFPyL或PyL）是一. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 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. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Deploy. com. PYLARIFY may be diluted with 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. 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. S. 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. , Sept. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. 3% over the prior. (LNTH) 1 Like. Lastly, net cash used in operating activities was $32. --(BUSINESS WIRE)--May 27, 2021-- Lantheus Holdings, Inc. Lantheus Holdings Inc. Lastly, net cash provided by operating activities was $116. 3 million, compared with $102. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. In the U. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. Lantheus Receives U. 7 million for the second quarter 2023, representing an increase of 43. 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. Lantheus Holdings, Inc. PDF Version. C. In the last reported quarter, the company’s earnings of 97 cents per share. TechneLite net revenue was $24. Lantheus Receives U. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. 4% from the prior year period. S. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 99 for the third quarter of 2022, representing an increase of approximately $0. “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. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. 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. 1% over the. PYLARIFY may be diluted with 0. Lantheus Receives U. NORTH BILLERICA, Mass. 2% for the week as of Friday afternoon,. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. Lantheus credited the revenue rise from increased sales for its Pylarify PSMA PET imaging agent, used to detect recurrent or metastatic prostate cancer, as well as increased use of its Definity. (NASDAQ:NASDAQ:LNTH) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ETCompany ParticipantsMary Anne Heino – President and Chief Executive Officer Mark. S. GAAP net. Eastern Time. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. An FDA-cleared medical device software, PYLARIFY AI V1. 01. 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. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. D. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. Lantheus Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. D. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Mark Kinarney. For men with prostate cancer, PYLARIFY. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. 99 for the third quarter of 2022, representing an increase of approximately $0. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. The creation of artificial high-performance photosynthetic assemblies with a tailorable antenna system to deliver absorbed solar energy to a photosynthetic reaction center,. Residents Only. S. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. BEDFORD, Mass. Worldwide revenue of $102. 2 million and $935. 96 and $0. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. 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. 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. , Nov. 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. In June, Lantheus announced that it has demonstrated the higher efficiency and consistency of the Pylarify AI platform while maintaining the diagnostic accuracy of Prostate-Specific Membrane. NORTH BILLERICA, Mass. We accelerated our growth. 1. 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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 00. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. com. – Paul Blanchfield, Chief Commercial Officer at Lantheus. Our presentations at EANM highlight new data on the clinical utility of our artificial intelligence solution to assess response to prostate cancer therapy,” said Etienne Montagut , Chief Business Officer, Lantheus . Lantheus Holdings. 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. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. But. But most. 7 million, up 12. In the last reported quarter, Lantheus earnings per share (EPS) of $1. Lantheus Receives U. Our products have practical applications in oncology, cardiology and more. m. [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. Melissa Downs Senior Director, Corporate Communications 646. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. 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 full year 2022, Lantheus forecasts PYLARIFY to be in a range of $300M to $325M and their. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). , [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. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. 2% for the week as of Friday afternoon,. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. , Progenics Pharmaceuticals, Inc. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 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. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. 8 million for the first quarter 2023, representing an increase of 44. S. 9% sodium chloride injection USP. Pylarify. #Lantheus was thrilled to be a Gold Sponsor of the 16th Clinical Trials on Alzheimer’s Disease conference (CTAD), which took place from Oct 24-27 in Boston! It was a wonderful opportunity to connect with our partners in the industry and academia who are using our investigational Tau PET imaging agent in their clinical trials. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. , Nov. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. 37. In the press release they say it will be available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the US by year end. Director, Corporate Communications. INDICATION. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. -1. distributor of PYLARIFY AI™, the first and only FDA-cleared artificial intelligence platform developed to assist standardized quantification of PSMA PET/CT scans. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. PYLARIFY Injection is designed to detect prostate-specific membrane. , Nov. 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. Pylarify is the largest growth driver for the company as it comprised 65% of. Nov 2014 - Sep 2017 2 years 11 months. News release. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. 9 mg ethanol in 0. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. §287(a). Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). 8% from the prior year period. PYLARIFY seems to be affected by the amount (level) of PSA in your blood. 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. , Nov. We have been thrilled with the response to PYLARIFY in the prostate cancer community, said Mary Anne Heino, President and Chief Executive Officer of Lantheus. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. Pylarify accounted for $160. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. Based in North Billerica, Mass. Lantheus Reports First Quarter 2023 Financial Results. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Pylarify PET detected at least one positive lesion in at least one body region (bone, prostate bed, pelvic lymph node, other lymph nodes, or soft tissue) in 60% of these patients. Jul. Progenics Pharmaceuticals, Inc. BEDFORD, Mass. INDICATION. 3% from the prior year period. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. 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’. 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. NORTH BILLERICA, Mass. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. 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. 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. The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. 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. com. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes. , Nov. 9 million for the first quarter 2022, representing an increase of 125. Syntermed announces its appointment by Lantheus Holdings, Inc. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging. In the U. Our products have practical applications in oncology, cardiology and more. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. Lantheus Holdings, Inc ( LNTH 0. Billerica, MA 01862 . com. . 18F-DCFPyL is now the first. com. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. Fax: 978-436-7296. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. , a Lantheus company 331. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. 5 million, representing 61. 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. In the U. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. 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. , CEO of POINT Biopharma. BEDFORD, Mass. 7 million, up 12. with suspected recurrence based on. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. 3 million for the third quarter 2022, representing an increase of 134. 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. m. S. Senior Director, Investor Relations. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. 8 million for the first quarter 2023, representing an increase of 44. This sample claim form is only an example. The company expects to. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. ” Prostate cancer is a common and usually slow-growing cancer. Sanchez-Crespo A. U. com. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. March 29, 2022 at 8:00 AM · 8 min read. ,. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. PYLARIFY Injection is designed to detect prostate-specific membrane. 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 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. 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:. 17%. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. 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 data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. 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. Q4 adjuested EPS grew +448% Y/Y to $1. Contact information For media. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. Melissa Downs Senior Director, Corporate Communications 646. “Today marks an important day for Lantheus and Progenics. is the parent company of Lantheus Medical Imaging, Inc. NEW YORK, Feb. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. Lantheus Receives U. 12. , VP, Medical Affairs E. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 1 million for the third quarter 2021, representing an increase of 15. 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. Lantheus Holdings, Inc. The FDA approved the F 18-labeled prostate-specific membrane antigen (PSMA)–targeted positron emission tomography (PET) imaging agent 18F-DCFPyL (Pylarify) for use in prostate cancer, according to an announcement from the company responsible for the agent, Lantheus Holdings, Inc. 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. S. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. m. 1-800-299-3431. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. June 12, 2023 08:30 ET | Source: 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; PYLARIFY AI™, an artificial intelligence platform. Lantheus expects their fully diluted adjusted earnings per share to be between $0.