, [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. 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. 31 Mar, 2022, 09:00 ET. 6 million and $425. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. as the first U. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancer. 2% for the week as of Friday afternoon,. , Nov. 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. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. 7 million is being distributed to the holders. North Billerica, MA: Progenics Pharmaceuticals, Inc. 28 May, 2021, 07:00 ET. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. Deploy. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform the way that clinicians manage and treat prostate cancer,” said Jean-Claude Provost, MD, Interim Chief Medical Officer, Lantheus. 18F-DCFPyL is now the first. and EXINI Diagnostics AB. (the Company) (NASDAQ: LNTH), a company committed to“Lantheus is a demonstrated commercial leader in the field of radiopharmaceuticals. The creation of artificial high-performance photosynthetic assemblies with a tailorable antenna system to deliver absorbed solar energy to a photosynthetic reaction center,. Lastly, net cash provided by operating activities was $108. In the U. 0% from the prior year period. Lantheus Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. Intended for U. 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. Lantheus Receives U. 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. NORTH BILLERICA, Mass. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. S. 9% Sodium Chloride Injection, USP. (the Company) (NASDAQ: LNTH), a company committed to“PYLARIFY AI has the potential to contribute meaningful insights to inform treatment selection and monitoring 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. In patients with. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. commercial products, particularly PYLARIFY and DEFINITY, in the face of competition; (ii) our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house. "There are several, and there will be new ones down the. 12. 6 million to the ante. CC-BY-4. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. 5 million for the first quarter 2023. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 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. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. (“the Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. “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. 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. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. 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. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. U. [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. Read more about Lantheus Announces Top Rated Oral Presentation. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. S. Worldwide revenue of $129. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. The company reported Q4 adjusted EPS of $1. 7 million for the third quarter 2023. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. 54, as compared to $0. PYLARIFY® may help detect metastases even when PSA levels are low. Assay the dose in a suitable dose calibrator prior to administration. 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. com. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. Lantheus' Key Products Driving Growth. PDF Version. 4% from the prior year period; GAAP net income of $43. PYLARIFY was 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. 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. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. 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. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. Image source: The Motley Fool. 3% over the prior year. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. 3 million for the third quarter 2022, representing an increase of 134. “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. 9 million for the first quarter 2022, representing an increase of 125. 4. 0. May 16, 2022 at 8:00 AM EDT. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. As part of the agreement with Novartis, Lantheus will provide PYLARIFY for the selection of patients with prostate cancer and Novartis will provide all PYLARIFY related clinical imaging data to Lantheus. 0% from the prior year period. Pylarify is the largest growth driver for the company as it comprised 65% of. 4% from the prior year period ; GAAP net income of $61. , Sept. S. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. TechneLite net revenue was $24. com. 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. 48 from the prior year period. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. The company also received a CE marking in Europe for PYLARIFY AI. (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. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. , Progenics Pharmaceuticals, Inc. Worldwide revenue of $263. 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. 1M in 2022, following a 25% YoY decline, according to the. 2 million for the third quarter 2022, compared to GAAP net loss of $13. 2 million for the third quarter 2022, compared to GAAP net loss of $13. (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. S. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. In June, Lantheus announced that it has demonstrated the higher efficiency and consistency of the Pylarify AI platform while maintaining the diagnostic accuracy of Prostate-Specific Membrane. S. 9, 2020-- Lantheus Holdings, Inc. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Lantheus Holdings. , Nov. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Sanchez-Crespo A. patents apply to our products: DEFINITY ® /DEFINITY. U. Follow the PYLARIFY® injection with an intravenous flush of 0. But most. 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 accounted for $160. 01. 7 million, compared with $101. NORTH BILLERICA, Mass. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify. PYLARIFY Injection is designed to detect prostate-specific membrane. In the U. com. Lantheus Holdings, Inc. In the U. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. Lantheus Holdings, Inc. Billerica, MA 01862 . Lastly, net cash provided by operating activities was $116. 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. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. C. The Company’s third quarter 2022 GAAP net income was $61. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. 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. 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. S. The Company updates its guidance for the first quarter and full year 2023 is as follows: PYLARIFY revenues in 1H23 were $405m - up 82% year-on-year - so it seems clear that PYLARIFY revenues have substantially more growth potential - Lantheus' guidance for total revenues in 2023. 7 million for the third quarter 2023. Melissa Downs Senior Director, Corporate Communications 646. Worldwide revenue of $102. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 9% Sodium Chloride Injection, USP. , Sept. S. US Customer Service/Order 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. Lantheus Receives U. 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. S. 17%. 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. An FDA-cleared medical device software, PYLARIFY AI V1. North Billerica, MA: Progenics Pharmaceuticals, Inc. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 6 million for the fourth quarter of 2021, representing an increase of 103. 6% and an increase of 25. The results. , Sept. com. Lantheus Holdings, Inc. GAAP. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. Melissa Downs. Lantheus provides a broad. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. PYLARIFY Injection is designed to detect prostate-specific membrane. In the U. Lantheus Reports First Quarter 2023 Financial Results. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. 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. Lastly, net cash used in operating activities was $32. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. 36%) Q3 2021 Earnings Call. (RTTNews) - Lantheus Holdings Inc. May 16, 2022 at 8:00 AM EDT. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. BEDFORD, Mass. Our products have practical applications in oncology, cardiology and more. The. , Progenics Pharmaceuticals, Inc. Lantheus says its technology can help improve the management of prostate cancer patients. S. m. S. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. 7 million, up 12. 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 has the potential to contribute meaningful and actionable information that can be used to personalize treatment plans in men with low PSA levels,” said Dr. Worldwide revenue of $321. The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. 0 is commercially available in the United States . Shares of Lantheus Holdings (LNTH-0. “Today marks an important day for Lantheus and Progenics. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. 1 million for the third quarter of 2021, representing an increase of 134. 9% sodium chloride injection USP. 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. 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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 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. Lantheus Medical Imaging has received approval from the U. 978-671-8842. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. For men with prostate cancer, PYLARIFY. . 47 on an adjusted basis, an increase of 48% over the prior-year quarter. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. 4% from the prior year period. In the U. Lantheus Holdings, Inc. Lantheus Holdings, inc ( LNTH 2. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. NORTH BILLERICA,. NEW YORK, Feb. Worldwide revenue of $239. 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. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). LinkedIn. with suspected recurrence based on. 1-800-299-3431. , Nov. While the company generated $527M in. , 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. For the full year 2022, Lantheus forecasts PYLARIFY to be in a range of $300M to $325M and their. Please refer to the map below for the production site nearest you. Eastern, Monday - Friday © 2023 Lantheus. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. 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. Find out why LNTH stock is a Strong Buy. Nov 2014 - Sep 2017 2 years 11 months. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. – Paul Blanchfield, Chief Commercial Officer at Lantheus. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. Progenics Pharmaceuticals, Inc. 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. 15. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Product Uses: diagnostic radiopharmaceutical . Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). Product Uses . (the “Company”) (NASDAQ: LNTH), an established leader and fully. 4% from the prior year period ; GAAP net income of $61. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. While the company generated $527M in. 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. 4. Nov 6, 2021, 2:00 p. 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 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. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. BEDFORD, Mass. Lantheus Receives 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. 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. GAAP net loss. PYLARIFY ® (piflufolastat F 18) injection (also known as 18 F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. 3M as the prostate cancer diagnostic agent Pylarify added $143. PRODUCT NAME: PYLARIFY (piflufolastat F18) injection CAS Number: 1423758-00-2 Product Uses: diagnostic radiopharmaceutical COMPANY. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. 7 million in the same period last year. • Calculate the necessary volume to administer based on calibration time and required dose. 3. 37, while. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. Purpose of this notice. 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. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. Welcome to the Lantheus Third Quarter 2023 Financial Results. (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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. D. April 29, 2022 07:07 ET | Source: Lantheus Holdings, Inc. Customer Service: 1-800-299-3431: Hours: 7:30 a. 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. com. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). US Customer Service/Order PYLARIFY®. Progenics Pharmaceuticals, Inc. 29. • Dispose of any unused PYLARIFY in compliance with applicable regulations. PYLARIFY seems to be affected by the amount (level) of PSA in your blood. June 12, 2023 at 8:30 AM EDT. Leadership provided initial guidance for FY2023 as well. 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. S. 8M of net sales while cardiovascular ultrasound enhancement. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. m. Minimum 15 minutes delayed. 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. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. 25 reported a year ago. With 3 million men living with prostate cancer and more than 18. D. “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. 1 million for the second quarter 2023, compared to GAAP net income of $43. Lantheus Receives U. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 9% Sodium Chloride Injection, USP. 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. NORTH BILLERICA, Mass. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. The company expects to. 331 Treble Cove Road . Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. This was another terrific quarter for Lantheus. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. disease. 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. Lastly, net cash provided by operating activities was $116. 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Worldwide revenue of $208. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. Hours: 8:30 am to 8:00 pm ET, Monday to Friday.