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% year-over-year, and progressed our. 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 to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. (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. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 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. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. 0. com. m. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. The company reports earnings on November 3, with analysts expecting the company to top last year's results. com. 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. 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. 1 million for the second quarter 2022, compared to GAAP net loss of $26. with suspected recurrence based on. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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 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. Lastly, net cash provided by operating activities was $116. Image source: The Motley Fool. com. "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. com. and EXINI Diagnostics AB and anWorldwide revenue of $223. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. “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. Our products have practical applications in oncology, cardiology and more. Email: [email protected] 04, 2021 07:00 ET | Source: Lantheus Holdings, Inc. S. Melissa Downs Senior Director, Corporate Communications 646-975-2533 media@lantheus. 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. 6 million and $425. “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. S. m. Lantheus Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. Worldwide revenue of $263. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . diagnostic radiopharmaceutical. INDICATION. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. 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. and EXINI Diagnostics AB. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. Lantheus Holdings, Inc. 9 mg ethanol in 0. 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 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. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. Lantheus Holdings, Inc. • Assay the dose in a suitable dose calibrator prior to administration. Jul 21, 2022 02:13PM EDT. News release. 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. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Product Uses . 0 is commercially available in the United States . S. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. "There are several, and there will be new ones down the. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. Lantheus Holdings, Inc. Director, Corporate Communications. 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. Intended for U. 9 million, up 33. 3 million for the third quarter 2022, representing an increase of 134. Melissa Downs Senior Director, Corporate Communications 646. 1 million for the third quarter 2021, representing an increase of 15. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. PDF Version. 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. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. PYLARIFY® (piflufolastat F 18) Injection Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:. Lantheus 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. S. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. , VP, Medical Affairs E. May 16, 2022 at 8:00 AM EDT. 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. 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. 9% over the prior year periods. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. June 12, 2023 at 8:30 AM EDT. , Nov. . PET/CT. 9% Sodium Chloride Injection USP. LNTH-1095 (also known as MIP-1095) is a small molecule PSMA-targeted 131 I-based radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) which combines a PSMA-targeted ligand, LNTH-1095, with the beta-emitting radioisotope 131 I. with suspected recurrence based on. BEDFORD, Mass. ET. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 7 million for the third quarter 2023. Minimum 15 minutes delayed. 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. , [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. NORTH BILLERICA, Mass. Lantheus Receives U. Food and Drug Administration (FDA) has approved. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. In the U. PYLARIFY® [package insert]. (the Company) (NASDAQ: LNTH), a company committed to“Lantheus is a demonstrated commercial leader in the field of radiopharmaceuticals. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. The approval covers the use of Lu177-PSMA-617 in patients who have metastatic prostate cancer that is hormone-resistant (also known as castrate-resistant) and whose. 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. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. S. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. m. 3 million for the third quarter 2022, representing an increase of 134. Fax: 978-436-7296. , [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. 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. 97 for the first quarter of 2022, representing an increase of approximately $0. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. (RTTNews) - Lantheus Holdings Inc. is the parent company of Lantheus Medical Imaging, Inc. 8% from the prior year period. 45%. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 31 Mar, 2022, 09:00 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 agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. Read More. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. • Dispose of any unused PYLARIFY in compliance with applicable regulations. 9 million for the first quarter 2022, representing an increase of 125. NORTH BILLERICA, Mass. INDICATION. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. 1% over the. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. 22, 2021 (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. 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. (the “Company”) (NASDAQ: LNTH), an established leader and fully. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. Find out why LNTH stock is a Strong Buy. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. PYLARIFY (piflufolastat F18) injection. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. 8 million for the first quarter 2023, representing an increase of 44. 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. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. , Sept. Shares of Lantheus Holdings (LNTH-0. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 36%) Q3 2021 Earnings Call. 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 presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus Receives U. ir@lantheus. 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. S. , Nov. Contact information For media. 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. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. Lastly, net cash provided by operating activities was $116. NORTH BILLERICA,. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 37, surpassing the consensus of $0. S. United States of America . 331 Treble Cove Road . 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. 1 million, or $0. 2% from the prior year quarter due to. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. The. , a Lantheus company. (NASDAQ:NASDAQ:LNTH) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ETCompany ParticipantsMary Anne Heino – President and Chief Executive Officer Mark. PYLARIFY® may help detect metastases even when PSA levels are low. Worldwide revenue of $300. 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. An FDA-cleared medical device software, PYLARIFY AI V1. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. ” Prostate cancer is a common and usually slow-growing cancer. Accessed May 11, 2022. 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. 3. BEDFORD, Mass. Jul. • Visually inspect the radiopharmaceutical solution. 2 million for the third quarter 2022, compared to GAAP net loss of $13. Lantheus Holdings, Inc. Eastern Time. 01. 1-800-299-3431. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. PYLARIFY PSMA - Where and when. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. The merger agreement was first announced on October 2, 2019 . 01. Sanchez-Crespo A. , Nov. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. (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. U. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 29. , Sept. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. “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. 5 million, representing 61. Lantheus Holdings, Inc ( LNTH 0. Lantheus' Key Products Driving Growth. The company also received a CE marking in Europe for PYLARIFY AI. Worldwide revenue of $239. In the U. S. 1% over the. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. But most. 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 Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. 8 million for the first quarter 2023, representing an increase of 44. All rights reserved. 48 from the prior year period. Q4 adjuested EPS grew +448% Y/Y to $1. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that the U. Coordination of care. Worldwide revenue of $208. S. The stock has been a big winner in 2022 thanks to the impressive growth racked up by recently launched imaging agent Pylarify. PYLARIFY identifies PSMA, the. 8% from the prior year period; GAAP net income of $94. It will need to spend additional. We obtained FDA approval for and successfully launched PYLARIFY®Lantheus will fund the all-cash license of exclusive worldwide rights, excluding certain territories 1, for PNT2002 and PNT2003 with cash on Lantheus’ balance sheet and committed financing. “Lantheus delivered another strong quarter and full year, highlighted by revenue performance which increased 38% and 25%, respectively,” said Mary Anne Heino, President and CEO. S. disease. 1. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 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. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. 9% Sodium Chloride Injection USP. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino , President and Chief Executive Officer. com. Lantheus 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. NORTH BILLERICA,. com. Welcome to the Lantheus Third Quarter 2023 Financial Results. Today, we put the spotlight on Lantheus Holdings for the first time. 2. Phone: 1-800-964-0446. NORTH BILLERICA, Mass. UAB Therapy Intensive Program – for Technologists. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. 9% sodium chloride injection USP. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. , Nov. Lantheus Holdings, Inc. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. In the U. 89 for the second quarter of 2022, representing an increase of approximately $0. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. 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 Meeting May 26, 2022 at 8:00 AM EDT PDF Version 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. 1. NORTH BILLERICA, Mass. This was another terrific quarter for Lantheus. 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. , [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. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. 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. 50 from the prior year period. 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. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. Lantheus Holdings, inc ( LNTH 2. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Customer Service: 1-800-299-3431: Hours: 7:30 a. The device provides general. , Nov. “This. 24%) Q2 2021 Earnings Call. is the parent company of Lantheus Medical Imaging, Inc. 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. 3. Lantheus Holdings Inc. 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. PYLARIFY is the only PSMA-imaging agent that is widely available through a diverse, multi-partner F18 distributor network, ensuring convenient and reliable supply MARKET ACCESS More than 90% of covered lives have access to PSMA PET with PYLARIFY1 UTILIZATION PYLARIFY is the #1 ordered PSMA PET imaging agent in the U. com. About Lantheus With more than 65 years of experience in delivering life. May 27, 2021 — Today, the FDA approved the 18F-DCFPyL PSMA PET imaging agent (also known as “PyL” for short or by its trade name “PYLARIFY”). 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. PYLARIFY was approved by the U. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. 45 and $0. (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. 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. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. D. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. com. S. 4 million. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. North Billerica, MA: 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’. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. 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. 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 Injection is designed to detect prostate-specific membrane. m. Pylarify accounted for $160. U. C. Phone: 1-800-964-0446. US Customer Service/Order PYLARIFY®. 99 for the third quarter of 2022, representing an increase of approximately $0. PYLARIFY (piflufolastat F18) injection. , [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. 61 for the second quarter. 2 million, compared with $129. Eastern Time. §287(a). Third quarter operating cash. Now turning to cash flow. S. 2% for the week as of Friday afternoon,. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. com. NORTH BILLERICA, Mass. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. PDF Version. 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. 4% from the prior year period. PYLARIFY AI deployment can be facilitated both as a secure web cloud application and as a local. 3% over the prior. Lantheus Receives U. 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. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes. diagnostic radiopharmaceutical. 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. 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. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. In the U. Lantheus Holdings Inc (NASDAQ:LNTH) made significant progress during the quarter with PYLARIFY and DEFINITY in its commercial portfolio, and with PNT2002 and MK-6240 in its pipeline. Melissa Downs. 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. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. “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. 9% Sodium Chloride Injection, USP. com. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0.