, Lantheus was founded in 1956 and formerly owned by Bristol Myers. (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. GAAP. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. 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 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. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. In the U. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. Lantheus Holdings, Inc. In the U. 3 million for the second quarter 2023. Lantheus Receives U. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). --(BUSINESS WIRE)--Dec. Deploy. 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. Under. About Lantheus With more than 65 years of experience in delivering life. NORTH BILLERICA,. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. PDF Version. Our products have practical applications in oncology, cardiology and more. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. com. This was another terrific quarter for Lantheus. June 12, 2023 at 8:30 AM EDT. 54. distributor of PYLARIFY AI™, the first and only FDA-cleared artificial intelligence platform developed to assist 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. (LNTH) 1 Like. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Accessed May 11, 2022. The company reports earnings on November 3, with analysts expecting the company to top last year's results. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancerNORTH BILLERICA, Mass. 88 and earnings of $1. 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. 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. Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA). 9% Sodium Chloride Injection USP. 2% for the week as of Friday afternoon,. , Nov. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Syntermed announces its appointment by Lantheus Holdings, Inc. Worldwide revenue of $239. 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. 37, surpassing the consensus of $0. PET/CT. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023, with the vast majority of our sequential growth driven by our existing accounts. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. , Sept. Now turning to cash flow. 1 million for the second quarter of 2021, representing an increase of 121. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. Residents Only. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. An FDA-cleared medical device software, PYLARIFY AI V1. 4. com. as the first U. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. , Nov. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. GAAP net. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. PYLARIFY (piflufolastat F18) injection . Pylarify is the largest growth driver for the company as it comprised 65% of. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. Lantheus' Key Products Driving Growth. 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:. 肿瘤学放射性药物 （帮助医疗保健专业人员发现、治疗和跟踪癌症的诊断和治疗方法）： ·PYLARIFY（也被称为Piflufolastat F-18、18F-DCFPyL或PyL）是一. Lantheus 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. Pylarify is the largest growth driver for the company as it comprised 65% of. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. S. 8M of net sales while cardiovascular ultrasound enhancement. PYLARIFY AI™ (aPROMISE) is the only deep learning enabled FDA-cleared medical device software to offer standardized PSMA PET reporting with PYLARIFY AI on PSMA PET/CT images, including those. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. BEDFORD, Mass. The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. “Today marks an important day for Lantheus and Progenics. 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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. “This. NORTH BILLERICA,. 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. "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. 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. Since then, Lantheus' sales have more than doubled. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. February 10, 2022 17:33 ET | Source: Lantheus Holdings, Inc. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 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. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. 9 million for the first quarter 2022, representing an increase of 125. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. Phone: 1-800-964-0446. 1% and 119. March 29, 2022 at 8:00 AM · 8 min read. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 4% from the prior year period. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. S. Mark Kinarney. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent. 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. 66 from the prior year period. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. disease. , [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. 52%) were up 21. BEDFORD, Mass. In the U. 1% over the. “In addition to FDA approval, inclusion in the guidelines. , [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. PYLARIFY PSMA - Where and when. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. SOFIE’s Vice President of Sales & Marketing, Mike Parisi, states, “We are thrilled to partner with Lantheus to commercially supply this new and. 99 for the third quarter of 2022, representing an increase of approximately $0. 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. 1 million in the prior year period; GAAP fully diluted net income per share of $1. 9 mg ethanol in 0. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. m. This indicates a strong confidence in Pylarify’s growth, even amidst new. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. Visit Investor Site. Morris MJ, Rowe SP, Gorin MA, et al. Shares of Lantheus Holdings (LNTH-0. diagnostic radiopharmaceutical. 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. 331 Treble Cove Road . 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”). "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the. S. with suspected recurrence based on. patents apply to our products: DEFINITY ® /DEFINITY. NORTH BILLERICA, Mass. 1 million for the third quarter of 2021, representing an increase of 134. 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. United States of America . FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly available68. Lantheus Holdings, Inc. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. 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. 47, as compared to $0. BEDFORD, Mass. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. With 3 million men living with prostate cancer and more than 18. S. com. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. This is an increase of 200% compared to the previous 30 days. 01. 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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. PYLARIFY identifies PSMA, the. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. Lantheus expects their fully diluted adjusted earnings per share to be between $0. m. U. com. 3% over the prior. • Assay the dose in a suitable dose calibrator prior to administration. S. Under a commercial supply agreement with Lantheus, SOFIE will roll out PYLARIFY via its national network, which has manufactured numerous PYLARIFY doses for Lantheus during the clinical trials. LNTH is expected to report second-quarter 2022 results on Jul 27. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. com. 9, 2020-- Lantheus Holdings, Inc. 2023 Annual Scan Potential Estimates 12. 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. 5 million, representing 61. North Billerica, MA: Progenics Pharmaceuticals, Inc. 9% Sodium Chloride Injection USP. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. Worldwide revenue of $208. 50. About Lantheus Holdings, Inc. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. ,. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. PYLARIFY works with PET/CT technology to produce a combined PET/CT scan that enables the reader of the PET/CT scan to detect and locate the disease. PRODUCT NAME: PYLARIFY (piflufolastat F18) injection CAS Number: 1423758-00-2 Product Uses: diagnostic radiopharmaceutical COMPANY. 5 million, representing 61. m. 9% sodium chloride injection USP. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. 0. Melissa Downs Senior Director, Corporate Communications 646. 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. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. 97 for the first quarter of 2022, representing an increase of approximately $0. TechneLite net revenue was $24. The results. C. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. , CEO of POINT Biopharma. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. 29. com. 3% over the prior year. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. S. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. 52%) were up 21. TechneLite net revenue was $24. 01. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. About Lantheus With more than 65 years of experience in delivering life. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. D. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. 4 million in revenue, up 25% year over year, and a net loss of $11. NORTH BILLERICA, Mass. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. 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. 8% from the prior year period. 1 million for the third quarter 2021, representing an increase of 15. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. The company also received a CE marking in Europe for PYLARIFY AI. 1-800-299-3431. Our presentations at EANM highlight new data on the clinical utility of our artificial intelligence solution to assess response to prostate cancer therapy,” said Etienne Montagut , Chief Business Officer, Lantheus . 2 million, compared with $129. 3. Lastly, net cash provided by operating activities was $116. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud to. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. (the Company) (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. PYLARIFY may be diluted with 0. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. The program is available to HCPs who have completed the PYLARIFY® Reader Training. Phone: 1-800-964-0446. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. 86 for the third quarter 2022, compared to. Intended for U. by year. 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. PYLARIFY AI™ is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. with suspected recurrence based on. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the. 9% Sodium Chloride Injection, USP. 9 mg ethanol in 0. , [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. 36%) Q3 2021 Earnings Call. • Assay the dose in a suitable dose calibrator prior to administration. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 17%. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. , Nov. Pylarify. 99 for the third quarter of 2022, representing an increase of approximately $0. In patients with. and Progenics Pharmaceuticals, Inc. Melissa Downs Senior Director, Corporate Communications 646. Our products have practical applications in oncology, cardiology and more. BEDFORD, Mass. In the U. 7 million for the third quarter 2023. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. Follow the PYLARIFY® injection with an intravenous flush of 0. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. Lantheus experienced tremendous growth in last 2 years thanks to the approval of a new imaging agent called PYLARIFY. Lastly, net cash provided by operating activities was $108. S. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men. S. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. Jul. , Progenics Pharmaceuticals, Inc. , Progenics Pharmaceuticals, Inc. Lantheus Holdings. GAAP. 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. (“the Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. , Sept. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the. Lantheus también está trabajando en el desarrollo de productos para otros tipos de cáncer, como los tumores neuroendocrinos, y en el diagnóstico y estadificación de la. Outside 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. INDICATION. 1 million for the second quarter 2022, compared to GAAP net loss of $26. 7 million, up 12. 4 million. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. NORTH BILLERICA, Mass. Follow. 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. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. Published online May 11, 2022. S. S. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. 9% over the prior year periods. NORTH BILLERICA, Mass. ET. 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. 0% from the prior year period. 4% from the prior year period. Heino , President and Chief Executive Officer of Lantheus . 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. 47, as compared to $0. 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. LinkedIn. 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 AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 61 per fully diluted share, as compared to GAAP net loss. “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. , a Lantheus company. Lantheus Holdings. The program is available to HCPs who have completed the PYLARIFY® Reader Training. . (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes. and EXINI Diagnostics AB. GAAP net loss. Senior Director, Investor Relations. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly available throughout the U. On the fourth-quarter 2022 earnings call in February, Lantheus Holdings’ management confirmed that it has been registering a robust uptick in sales of its PYLARIFY, an F 18-labelled PSMA. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus Holdings Inc. Please refer to the map below for the production site nearest you. 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. 0. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. NORTH BILLERICA, Mass. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. , VP, Medical Affairs E. 6 million for the fourth quarter of 2021, representing an increase of 103. Worldwide revenue of $239. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). Lantheus Holdings, Inc. , Progenics Pharmaceuticals, Inc. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. PYLARIFY was approved by the U. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. 1. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Lantheus 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. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. 0 million and $150. 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. Lantheus Holdings, inc ( LNTH 2. 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. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. Lantheus Reports Second Quarter 2023 Financial Results. 3 million, compared with $102. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. U. 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. 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’. Lantheus Holdings, Inc. , Nov.