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. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly availableLantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. 3% from the prior year period. North Billerica, MA: Progenics Pharmaceuticals, Inc. Pylarify. as the first U. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. 9% Sodium Chloride Injection USP. In the U. In the last reported quarter, the company’s earnings of 97 cents per share. LinkedIn. 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. COMPANY IDENTIFICATION: 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. Lantheus Receives U. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. It will need to spend additional. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. 5 million, representing 61. 52%) were up 21. Read More. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 [email protected] Anne Heino: Thank you, Mark, and good morning to everyone. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. The Company’s third quarter 2022 GAAP net income was $61. S. S. 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. 331 Treble Cove Road . , [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. com. “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. 331 Treble Cove Road . “Today marks an important day for Lantheus and Progenics. S. 7% year-over-year, and progressed our. BEDFORD, Mass. S. 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. 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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. Lantheus Holdings. 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. 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. 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. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. David Crawford, M. com. 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. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 1 million for the second quarter 2022, compared to GAAP net loss of $26. Customer Service: 1-800-299-3431: Hours: 7:30 a. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. The Pylarify AI system is a deep learning algorithm that allows physicians to. With 3 million men living with prostate cancer and more than 18. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. The. Email: cspyl@lantheus. --(BUSINESS WIRE)--May 27, 2021-- Lantheus Holdings, Inc. 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. October 19, 2023. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. , Nov. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. The results. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. 7 million in the same period last year. 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. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. 3 million for the third quarter 2022, representing an increase of 134. Heino , President and Chief Executive Officer of Lantheus . Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. INDICATION. Nov 2014 - Sep 2017 2 years 11 months. 45 and $0. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 1 million for the second quarter of 2021, representing an increase of 121. 88 and earnings of $1. S. Food and Drug Administration in May 2021. 00. 24%) Q2 2021 Earnings Call. 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. 1M in 2022, following a 25% YoY decline, according to the. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. The approval covers the use of Lu177-PSMA-617 in patients who have metastatic prostate cancer that is hormone-resistant (also known as castrate-resistant) and whose tumors. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. LNTH earnings call for the period ending June 30, 2021. 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. Melissa Downs. 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. GAAP net. 2% from the prior year quarter due to. 4 million in revenue, up 25% year over year, and a net loss of $11. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 8 million for the first quarter 2023, representing an increase of 44. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 12. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. is the parent company of Lantheus Medical Imaging, Inc. Melissa Downs Senior Director, Corporate Communications 646. INDICATION. March 29, 2022 at 8:00 AM · 8 min read. 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. and EXINI Diagnostics AB and anWorldwide revenue of $223. m. Melissa Downs Senior Director, Corporate Communications 646. 37. • Calculate the necessary volume to administer based on calibration time and required dose. ET. 86 for the third quarter 2022, compared to. Nov 6, 2021, 2:00 p. S. with suspected recurrence based on. BEDFORD, Mass. The. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. 8 million for the first quarter 2023, representing an increase of 44. S. ,. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. 0% from the prior year period. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. Morris MJ, Rowe SP, Gorin MA, et al. On-site plant will produce. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. . Worldwide revenue of $102. m. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Melissa Downs Senior Director, Corporate Communications 646. 0 million and $150. 1 million in the prior year period; GAAP fully diluted net income per share of $1. 0 is commercially available in the United States . Follow. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. In the U. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. Q4 adjuested EPS grew +448% Y/Y to $1. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 9% Sodium Chloride Injection USP. 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. Our products have practical applications in oncology, cardiology and more. 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. 96 and $0. com. 9 million, up 33. 3. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. , Nov. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. The Company’s second quarter 2022 GAAP net income was $43. Lantheus Receives U. 3 million for the third quarter 2022, representing an increase of 134. 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, while. S. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Follow the PYLARIFY® injection with an intravenous flush of 0. 0 million and $150. com. 01. Read more about Lantheus Announces Top Rated Oral Presentation. • Visually inspect the radiopharmaceutical solution. 6 million for the fourth quarter of 2021, representing an increase of 103. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. 47, as compared to $0. with suspected recurrence based on. . . “The transaction leverages Lantheus’. Find out why LNTH stock is a Strong Buy. PYLARIFY (piflufolastat F18) injection. 8 million, compared to a loss of $21. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. --(BUSINESS WIRE)--Dec. United States of America . Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for 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. Lantheus Original Approval date: May 26, 2021. Lantheus Holdings, Inc. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. 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. 0% from the prior year period. 50. 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. In the press release they say it will be available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the US by year end. Worldwide revenue of $321. (RTTNews) - Lantheus Holdings Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent. Greater Chicago Area. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. PYLARIFY Injection is designed to detect prostate-specific membrane. The following U. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. #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. (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. 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 to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. 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. Under. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 86 per fully diluted share, as compared to GAAP net loss of. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy: Locally Recurrent or New/Progressive PCa: OSPREY COHORT B; Safety; CASE STUDIES; HOW TO USE PYLARIFY® REIMBURSEMENT AND AVAILABILITY; PYLARIFY AI™ PYLARIFY AI™ Overview; What Is PYLARIFY AI™? PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 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. May 4, 2023 at 7:00 AM · 10 min read. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. “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. by year. , VP, Medical Affairs E. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. 7 million for the second quarter 2023, representing an increase of 43. Jul 28, 2021, 8:00 a. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. 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. 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. D. 29. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. 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. Lantheus Holdings’ Pylarify injection is a fluorinated small molecule PSMA-targeted PET imaging agent that allows for the visualization of lymph nodes, bone and soft tissue. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). PYLARIFY Injection is designed to detect prostate-specific membrane. Lantheus Holdings, Inc. 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. Billerica, MA 01862 . 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. TechneLite net revenue was $24. 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. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. S. 6 million and $425. 4% from the prior year period ; GAAP net income of $61. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. S. 1% over the. Lantheus Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. Worldwide revenue of $239. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. 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. PYLARIFY –Prostate Cancer Franchise Overview Paul Blanchfield, Chief Commercial Officer Etienne Montagut, Chief Business Officer Aseem Anand, VP of Digital Solutions PYLARIFY Key Opinion Leader Panel Moderator: Bela Denes, M. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. , a Lantheus company. 1 million for the third quarter 2021, representing an increase of 15. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. (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. Developed by Lantheus, PYLARIFY ® was recently approved by 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. 978-671-8842. 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. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. com. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. to 6:00 p. BEDFORD, Mass. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 [email protected] has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. NEW YORK, Feb. OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 men with either high-risk prostate cancer (Cohort A; n=268) or radiologic evidence of recurrence (Cohort B; n=117) OSPREY assessed the sensitivity, specificity, PPV, and NPV in pelvic lymph nodes for PYLARIFY® PET/CT. 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. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. 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. , Nov. Pylarify is the largest growth driver for the company as it comprised 65% of. But most. 2 million for the third quarter 2022, compared to GAAP net loss of $13. is the parent company of Lantheus Medical Imaging, Inc. S. 1 million for the third quarter of 2021, representing an increase of 134. 97 for the first quarter of 2022, representing an increase of approximately $0. Lastly, net cash provided by operating activities was $108. February 16, 2023 at 8:30 AM EST. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. GAAP. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. Accessed May 11, 2022. While the company generated $527M in. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 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. 6% and an increase of 25. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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. Product Uses: diagnostic radiopharmaceutical . (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 9 million for the first quarter 2022, representing an increase of 125. “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. 3% over the prior. 9 mg ethanol in 0. May 16, 2022 at 8:00 AM EDT. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. S. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. For men with prostate cancer,. Lantheus says its technology can help improve the management of prostate cancer patients. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. The merger agreement was first announced on October 2, 2019 . 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. 3% over the prior year. , a Lantheus company. and EXINI Diagnostics AB. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. PRODUCT NAME: PYLARIFY (piflufolastat F18) injection CAS Number: 1423758-00-2 Product Uses: diagnostic radiopharmaceutical COMPANY. BEDFORD, 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. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. , [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. 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. 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. PYLARIFY® may help detect metastases even when PSA levels are low. Lantheus Receives U. Lantheus Receives U. 7 million for the second quarter 2023, representing an increase of 43. 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. NORTH BILLERICA, Mass. 9% Sodium Chloride Injection, USP. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. 2 million for the third quarter 2022, compared to GAAP net loss of $13. by year endNORTH BILLERICA, Mass. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis. 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. Lastly, net cash used in operating activities was $32. Lantheus Holdings, Inc. 1 million for the fourth quarter and full year 2022, representing increases of 103. Quote. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. [email protected] provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. UAB Therapy Intensive Program – for Technologists. It is the #1 PSMA PET Imaging. PYLARIFY® IS UNIQUE. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. SOFIE’s Vice President of Sales & Marketing, Mike Parisi, states, “We are thrilled to partner with Lantheus to commercially supply this new and. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. 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. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. This sample claim form is only an example. com. – Paul Blanchfield, Chief Commercial Officer at Lantheus. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. In the U. Assay the dose in a suitable dose calibrator prior to administration. The company reports earnings on November 3, with analysts expecting the company to top last year's results. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. CC-BY-4. 7 million, up 12. 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. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 47, as compared to $0. 0. NORTH BILLERICA,. patents apply to our products: DEFINITY ® /DEFINITY. S. S. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a.