Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. 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. 86 per fully diluted share, as compared to GAAP net loss of. 1. 99 for the third quarter of 2022, representing an increase of approximately $0. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Melissa Downs Senior Director, Corporate Communications 646. “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. S. 9% Sodium Chloride Injection, USP. 61 per fully diluted share, as compared to GAAP net loss. Customer Service: 1-800-299-3431: Hours: 7:30 a. PDF Version. , Sept. “Being selected by Lantheus to partner to administer the first dose of PYLARIFY is an honor, and it’s humbling to know that GenesisCare will be potentially helping men with prostate cancer, while improving access to high-quality care for our patients. “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. Worldwide revenue of $321. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. , Progenics Pharmaceuticals, Inc. 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. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. disease. 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. 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. 2. 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. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for 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. S. S. 4% from the prior year period; GAAP net income of $43. with suspected recurrence based on. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. This page is intended to serve as notice under 35 U. 4 million. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. Lastly, net cash provided by operating activities was $108. 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. The program is available to HCPs who have completed the PYLARIFY® Reader Training. , 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; PYLARIFY AI™, an artificial intelligence platform. The company expects to. 2% for the week as of Friday afternoon,. 9 mg ethanol in 0. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. (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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. 7 million in the same period last year. 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. Q4 adjuested EPS grew +448% Y/Y to $1. , [18 F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. Worldwide revenue of $129. Pylarify is labeled with F-18 and homes in on PSMA, a protein that is overexpressed on the surface of more than 90% of. Lastly, net cash provided by operating activities was $116. 3% over the prior. NORTH BILLERICA, Mass. 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. Lantheus Receives U. Pylarify accounted for $160. INDICATION. Email: [email protected] 04, 2021 07:00 ET | Source: Lantheus Holdings, Inc. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. Read more about Lantheus Announces Top Rated Oral Presentation. 97 for the first quarter of 2022, representing an increase of approximately $0. 3 million for the third quarter 2022, representing an increase of 134. S. Lantheus Receives U. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 48 from the prior year period. S. 9% Sodium Chloride Injection USP. 50 from the prior year period. In the U. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. , a Lantheus company . News release. Lantheus Holdings, Inc. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. 7 million, up 12. 12. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. BEDFORD, Mass. Syntermed announces its appointment by Lantheus Holdings, Inc. 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. S. 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. While the company generated $527M in. With 3 million men living with prostate cancer and more than 18. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. LNTH earnings call for the period ending June 30, 2021. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. 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. Nov 6, 2021, 2:00 p. The Company’s second quarter 2022 GAAP net income was $43. 4% from the prior year period ; GAAP net income of $61. 01. 50. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. 2 million for the fourth quarter and full year 2021, representing an increase of 37. 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. 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. 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. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. This sample claim form is only an example. 1% over the. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 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. June 12,. As part of the agreement with Novartis, Lantheus will provide PYLARIFY for the selection of patients with prostate cancer and Novartis will provide all PYLARIFY related clinical imaging data to Lantheus. PDF. 7% year-over-year, and progressed our. is the parent company of Lantheus Medical Imaging, Inc. Pylarify is the largest growth driver for the company as it comprised 65% of. S. 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. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. PYLARIFY, approved by the FDA in May 2021, is the first commercially and widely available prostate-specific membrane antigen (PSMA) PET imaging agent. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud to. , Nov. 01. Sanchez-Crespo A. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. 1 million for the fourth quarter and full year 2022, representing increases of 103. PYLARIFY AI deployment can be facilitated both as a secure web cloud application and as a local. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. 47, as compared to $0. , Nov. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. Mid-cap Lantheus Holdings has been on a revenue growth spurt boosted by a new product called Pylarify, which helps detect prostate cancer in an imaging test. PYLARIFY® (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. 66 from the prior year period. About Lantheus Holdings, Inc. The following U. 86 for the third quarter 2022, compared to. 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. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. 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. An FDA-cleared medical device software, PYLARIFY AI V1. Residents Only. Lantheus Holdings, Inc. by year. Lantheus Holdings, Inc. 3. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. 37. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). 47, as compared to $0. October 19, 2023. 3M as the prostate cancer diagnostic agent Pylarify added $143. Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA). Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. S. Lantheus’ product, PYLARIFY ® (piflufolastat F 18) injection, is a radioactive diagnostic agent indicated for PET imaging of PSMA positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and/or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. 8M of net sales while cardiovascular ultrasound enhancement. Product Uses: diagnostic radiopharmaceutical . Our products have practical applications in oncology, cardiology and more. PDF Version. , Nov. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. PYLARIFY may be diluted with 0. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Pylarify. 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. It is the #1 PSMA PET Imaging. 2 million for the third quarter 2022, compared to GAAP net loss of $13. com. 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. 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. June 12, 2023 at 8:30 AM EDT. 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. PYLARIFY was approved by the U. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. with suspected recurrence based on. PYLARIFY® CODING AND BILLING GUIDE | PYLARIFY® Reimbursement Hotline: 844-339-8514 PYLARIFY® and the associated services provided in a physician office are billed on the CMS-1500 claim form or its electronic equivalent. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. 1-800-299-3431. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. NORTH BILLERICA, Mass. 3% over the prior year. S. , [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. 2023 Annual Scan Potential Estimates 12. Lantheus Receives U. ir@lantheus. S. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. North Billerica, MA: Progenics Pharmaceuticals, Inc. Follow the PYLARIFY® injection with an intravenous flush of 0. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. $ 68. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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. 2 million, or $0. 24%) Q2 2021 Earnings Call. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. • Visually inspect the radiopharmaceutical solution. Lantheus' Key Products Driving Growth. For men with prostate cancer, PYLARIFY. Lantheus Holdings, inc ( LNTH 2. Lantheus Holdings, Inc. 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. 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. On-site plant will produce. Lantheus Holdings Inc. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. S. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. 2 million, compared with $129. February 10, 2022 17:33 ET | Source: Lantheus Holdings, Inc. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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. and EXINI Diagnostics AB. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. Phone: 1-800-964-0446. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. 9 million, up 33. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Quote. U. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. In the U. NORTH BILLERICA, Mass. 8 million, compared to a loss of $21. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. 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. 6 million worth of sales while DEFINITY contributed $63. Lantheus Receives U. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Worldwide revenue of $321. 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 Holdings, Inc. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Email: cspyl@lantheus. The FDA just recently approved the PSMA (piflfolastat F 18) scan. GAAP. Lantheus Holdings, Inc. With 3 million men living with prostate cancer and more than 18 million adults. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Developed by Lantheus, PYLARIFY ® was recently approved by the U. 4 million in revenue, up 25% year over year, and a net loss of $11. 37, while. 1. PYLARIFY Injection is designed to detect prostate-specific membrane. United States of America . In the U. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. PET/CT. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. 9% sodium chloride injection USP. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. 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. 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 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. About Lantheus With more than 65 years of experience in delivering life. Lantheus Holdings, Inc. 7 million for the third quarter 2023. NORTH BILLERICA, Mass. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. "There are several, and there will be new ones down the. PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. §287(a). Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. 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. Coordination of care. S. 9% Sodium Chloride Injection, USP. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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. Based in North Billerica, Mass. 8% from the prior year period. S. 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. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. 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. PYLARIFY (piflufolastat F18) injection. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. 5 million, representing 61. Purpose of this notice. BEDFORD, Mass. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. Lantheus Holdings, Inc. 99 for the third quarter of 2022, representing an increase of approximately $0. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA 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. , 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® CODING AND BILLING GUIDE | PYLARIFY® Reimbursement Hotline: 844-339-8514 PYLARIFY® and the associated services provided in a physician office are billed on the CMS-1500 claim form or its electronic equivalent. • Calculate the necessary volume to administer based on calibration time and required dose. , Nov. Melissa Downs Senior Director, Corporate Communications 646. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. Product Uses . “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. This was another terrific quarter for Lantheus. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) continued market expansion and penetration for our established commercial products, particularly PYLARIFY and DEFINITY, in a competitive environment in which other imaging agents have been approved. NORTH BILLERICA, Mass. 54, as compared to $0. Worldwide revenue of $263. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. 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. 0 is commercially available in the United States . NORTH BILLERICA,. is the parent company of Lantheus Medical Imaging, Inc. 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. 2021 was a year of significant achievements for Lantheus. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Nov 2014 - Sep 2017 2 years 11 months. S. GAAP. 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. (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. ” Prostate cancer is a common and usually slow-growing cancer. This other product, even though it was, I'll say, riding the wave of the momentum that. and EXINI Diagnostics AB. with suspected recurrence based on. (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. Strategic architect for the Uro-oncology franchise. --(BUSINESS WIRE)--May 27, 2021-- Lantheus Holdings, Inc. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. as the first U. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. NORTH BILLERICA, Mass. Intended for 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. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. 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. In. 5 million, representing 61. Image source: The Motley Fool. 9 million for the first quarter 2022, representing an increase of 125. 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. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. 6 million to the ante. Mark Kinarney. Image source: The Motley Fool. 7 million for the second quarter 2023, representing an increase of 43. (RTTNews) - Lantheus Holdings Inc.