SOFIE’s Vice President of Sales & Marketing, Mike Parisi, states, “We are thrilled to partner with Lantheus to commercially supply this new and. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. We accelerated our growth. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. 18F-DCFPyL is now the first. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly availableLantheus delivered a BIG and welcome beat-and-raise quarter and shares were up as much as +20%, poking their nose over $71. S. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. , a Lantheus company . 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. Lantheus Holdings, Inc. , a Lantheus company. This is an increase of 200% compared to the previous 30 days. Worldwide revenue of $300. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. For International Transportation Emergencies Call CC-BY-4. October 19, 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 agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. 7 million for the third quarter 2023. 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. distributor of PYLARIFY AI™, the first and only FDA-cleared artificial intelligence platform developed to assist standardized quantification of PSMA PET/CT scans. INDICATION. In the last reported quarter, the company’s earnings of 97 cents per share. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. About Lantheus With more than 65 years of experience in delivering life. with suspected recurrence based on. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. 31 Mar, 2022, 09:00 ET. Follow the PYLARIFY® injection with an intravenous flush of 0. Assay the dose in a suitable dose calibrator prior to administration. All rights reserved. In the last reported quarter, Lantheus earnings per share (EPS) of $1. The company reports earnings on November 3, with analysts expecting the company to top last year's results. Coordination of care. B Riley has resumed coverage of Lantheus Holdings (NASDAQ:LNTH) with a buy citing the company's growth trajectory due to the the launch of Pylarify, a prostate-specific membrane antigen (PSMA. PYLARIFY® (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. 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. S. , Nov. PYLARIFY AI deployment can be facilitated both as a secure web cloud application and as a local. Using PYLARIFY AI™ to locate PSMA-avid lesions and track changes over time, investigators were able to determine that the change in the automated PSMA scan. 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. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. Product Uses . 96 and $0. S. 4% from the prior year period. 12. In the U. 331 Treble Cove Road . Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. Melissa Downs Senior Director, Corporate Communications 646. 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. Lastly, net cash provided by operating activities was $116. 45 and $0. 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’. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. ,. BEDFORD, Mass. 7 million in the same period last year. Sanchez-Crespo A. diagnostic radiopharmaceutical. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Based in North Billerica, Mass. 4% from the prior year period. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. 8 million for the first quarter 2023, representing an increase of 44. U. 97 for the first quarter of 2022, representing an increase of approximately $0. PYLARIFY Injection is designed to detect prostate-specific membrane. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. S. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. NORTH BILLERICA, Mass. Our products have practical applications in oncology, cardiology and more. 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. Welcome to the Lantheus Third Quarter 2023 Financial Results. 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. 54. Worldwide revenue of $239. PYLARIFY may be diluted with 0. 54, as compared to $0. Melissa Downs Senior Director, Corporate Communications 646. 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. 1 million, or $0. 86 for the third quarter 2022, compared to. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. 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. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. 9 mg ethanol in 0. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting September 1, 2023 at 8:30 AM EDT BEDFORD, Mass. Residents Only. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancerNORTH BILLERICA, Mass. Their experience with these complex products and established footprint in commercializing PYLARIFY and AZEDRA makes them an ideal collaborator for these programs,” said Joe McCann, Ph. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. , a Lantheus company 331. 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. Jul. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. With 3 million men living with prostate cancer and more than 18 million adults. 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. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. Lantheus expects their fully diluted adjusted earnings per share to be between $0. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). While the company generated $527M in. “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. 2% from the prior year quarter due to. Nov 6, 2021, 2:00 p. Now turning to cash flow. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. m. This means that a negative PYLARIFY PET/CT scan does not rule out that you have prostate cancer, and a positive PYLARIFY PET/CT scan does not confirm that you have prostate cancer. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. S. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. , Nov. NEW YORK, Jan. Worldwide revenue of $239. The company is well-positioned to generate substantial free cash flow The cash flow statement provides a detailed overview of the cash inflows and outflows of a company over a specified period. 8M of net sales while cardiovascular ultrasound enhancement. 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. 3% over the prior year. 0% from the prior year period. 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. com. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. m. 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. • Dispose of any unused PYLARIFY in compliance with applicable regulations. BEDFORD, Mass. 7 million, compared with $101. Lantheus Holdings, Inc. ET. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus Holdings, inc ( LNTH 2. 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. Worldwide revenue of $129. is the parent company of Lantheus Medical Imaging, Inc. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. Lastly, net cash provided by operating activities was $108. CAS Number: 1423758-00-2. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. D. 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. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. 0% from the prior year period. On the fourth-quarter 2022 earnings call in February, Lantheus Holdings’ management confirmed that it has been registering a robust uptick in sales of its PYLARIFY, an F 18-labelled PSMA. The Company’s second quarter 2022 GAAP net income was $43. This sample claim form is only an example. , Progenics Pharmaceuticals, 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. Mark Kinarney. 1% and 119. 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. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. 2% from the prior year quarter due to. 7 million, up 12. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. We executed on our strategy to accelerate growth, diversify our commercial and development portfolios, and position Lantheus as a category leader in the markets we serve. S. $ 68. 66 from the prior year period. Pylarify is the largest growth driver for the company as it comprised 65% of. com. NORTH BILLERICA, Mass. 0. com. S. 8 million for the first quarter 2023, representing an increase of 44. Lantheus Holdings, Inc. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. INDICATION. 01. Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA). 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. , [18F]-DCFPyL was approved by the FDA in May of 2021 and is commercially available as PYLARIFY® (Piflufolastat F 18 Injection) and sold by Lantheus. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. 3 million for the third quarter 2022, representing an increase of 134. LNTH is expected to report second-quarter 2022 results on Jul 27. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly availableEven if Bracco were to secure 40%+ share in an expanding F-18 PSMA PET imaging market over the next 3 years, the Truist team still thinks Pylarify and Lantheus are undervalued, especially with the. 0. 47, as compared to $0. , Progenics Pharmaceuticals, Inc. INDICATION. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. , June 12, 2023 (GLOBE NEWSWIRE) — 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. 9% Sodium Chloride Injection USP. US Customer Service/Order PYLARIFY®. , VP, Medical Affairs E. (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. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. BEDFORD, Mass. Pylarify. com. David Crawford, M. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Nov 2014 - Sep 2017 2 years 11 months. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. 6 million and $425. 8% from the prior year period; GAAP net income of $94. Lantheus experienced tremendous growth in last 2 years thanks to the approval of a new imaging agent called PYLARIFY. 3 million for the third quarter 2022, representing an increase of 134. • Visually inspect the radiopharmaceutical solution. #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. 3. 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 presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. S. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. The stock has been a big winner in 2022 thanks to the impressive growth racked up by recently launched imaging agent Pylarify. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. 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. While the company generated $527M in. GAAP net. 9 mg ethanol in 0. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. In the U. BEDFORD, Mass. 0. Visit Investor Site. The device provides general. June 12,. In the U. But most. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. S. , Nov. Greater Chicago Area. April 29, 2022 07:07 ET | Source: Lantheus Holdings, Inc. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. 15. 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. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. ET. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. , Nov. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Read 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. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. In the U. 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. Lantheus Holdings, Inc ( LNTH 0. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. and EXINI Diagnostics AB. 17%. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. 2 million, compared with $129. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. NORTH BILLERICA, Mass. PYLARIFY® may help detect metastases even when PSA levels are low. 3 million for the third quarter 2022, representing an increase of 134. In the 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 agent. S. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). In hindsight it appears that the sellside failed to appreciate Pylarify's potential. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. 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. 37. • Calculate the necessary volume to administer based on calibration time and required dose. 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. 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. "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. But. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to expand its portfolio of commercial and clinical-stage radiopharmaceutical assets. “Lantheus delivered another strong quarter and full year, highlighted by revenue performance which increased 38% and 25%, respectively,” said Mary Anne Heino, President and CEO. Strategic architect for the Uro-oncology franchise. 1 million for the second quarter 2022, compared to GAAP net loss of $26. (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. 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. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. GAAP net. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. The program is available to HCPs who have completed the PYLARIFY® Reader Training. S. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. Lantheus Announces Presentations Featuring PYLARIFY AI at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12, 2023 BEDFORD, Mass. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. 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. PYLARIFY Injection is designed to detect prostate-specific membrane. Phone: 1-800-964-0446. 4 million. 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:. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. com. NORTH BILLERICA, Mass. 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. m. 7% year-over-year, and progressed our. In the U. Outside U. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. . TechneLite net revenue was $24. 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. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. 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. PYLARIFY (piflufolastat F18) injection. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. . “Lantheus delivered another strong quarter and full year, highlighted by revenue performance which increased 38% and 25%, respectively,” said Mary Anne Heino, President and CEO. , CEO of POINT Biopharma. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. , a Lantheus company . 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 agent. 47, as compared to $0. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. U. North Billerica, MA: Progenics Pharmaceuticals, Inc. -1. 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. Shares of Lantheus Holdings (LNTH-0. 52%) were up 21. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. 2 million for the third quarter 2022, compared to GAAP net loss of $13. PDF Version. 9, 2020-- Lantheus Holdings, Inc. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Worldwide revenue of $300. is the parent company of Lantheus Medical Imaging, Inc. 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. Email: [email protected] 04, 2021 07:00 ET | Source: Lantheus Holdings, Inc. 7 million for the second quarter 2023, representing an increase of 43. “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. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. com. NORTH BILLERICA, Mass. 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. 1 million for the second quarter of 2021, representing an increase of 121. PRODUCT NAME: PYLARIFY (piflufolastat F18) injection CAS Number: 1423758-00-2 Product Uses: diagnostic radiopharmaceutical COMPANY. • Dispose of any unused PYLARIFY in compliance with applicable regulations. 9 million for the first quarter 2022, representing an increase of 125. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. The company reported Q4 adjusted EPS of $1. TechneLite net revenue was $24. 47, as compared to $0. 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. Lantheus Receives U. Billerica, MA 01862 . Image source: The Motley Fool. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®.