S. BEDFORD, Mass. 331 Treble Cove Road . Follow. 1% over the. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. But most. Worldwide revenue of $263. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. 0. 2023 Annual Scan Potential Estimates 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; PYLARIFY AI™, an artificial intelligence platform. 00. SOFIE’s Vice President of Sales & Marketing, Mike Parisi, states, “We are thrilled to partner with Lantheus to commercially supply this new and. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that the U. Melissa Downs Senior Director, Corporate Communications 646. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals 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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 24%) Q2 2021 Earnings Call. The company also received a CE marking in Europe for PYLARIFY AI. 0% from the prior year period. May 4, 2023 at 7:00 AM · 10 min read. , a Lantheus company. 1-800-299-3431. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. March 29, 2022 at 8:00 AM · 8 min read. 7 million for the third quarter 2023. 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. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. com. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. Lantheus will fund the all-cash license of exclusive worldwide rights, excluding certain territories 1, for PNT2002 and PNT2003 with cash on Lantheus’ balance sheet and committed financing. PYLARIFY® (piflufolastat 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. GAAP net. June 12,. by year. Lantheus Receives U. 3. , Nov. In the U. , [18F]-DCFPyL was approved by the FDA in May of 2021 and is commercially available as PYLARIFY® (Piflufolastat F 18 Injection) and sold by Lantheus. 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. and Progenics Pharmaceuticals, Inc. 3 million, compared with $102. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. 646-975-2533. In the U. 4. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 9% Sodium Chloride Injection, USP. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. 7 million is being distributed to the holders. November 29, 2021 08:30 ET | Source: 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. 3% over the prior year. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the. Third quarter operating cash. Worldwide revenue of $239. 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’ 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. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. Quote. Lantheus Holdings, Inc ( LNTH 0. com. 9, 2020-- Lantheus Holdings, Inc. ” Prostate cancer is a common and usually slow-growing cancer. About Lantheus With more than 65 years of experience in delivering life. 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. Published online May 11, 2022. While the company generated $527M in. 01. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. 2 million and $935. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. We executed on our strategy to accelerate growth, diversify our commercial and development portfolios, and position Lantheus as a category leader in the markets we serve. , a Lantheus company. Lantheus' Key Products Driving Growth. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Pylarify. Progenics Pharmaceuticals, Inc. Lantheus Reports Second Quarter 2023 Financial Results. 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. 48 from the prior year period. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. 54. 97 for the first quarter of 2022, representing an increase of approximately $0. Worldwide revenue of $129. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 6 million to the ante. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. TechneLite net revenue was $24. Residents Only. 1. com. Lantheus Reports First Quarter 2023 Financial Results. 4 million in revenue, up 25% year over year, and a net loss of $11. (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. 12. Melissa Downs Senior Director, Corporate Communications 646. 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. NORTH BILLERICA,. S. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 25 reported a year ago. Lantheus Holdings, Inc. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. In the U. 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. 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 . S. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 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. U. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. 47, as compared to $0. 2 million, or $0. 15. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. , Nov. 9% Sodium Chloride Injection, USP. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. B Riley has resumed coverage of Lantheus Holdings (NASDAQ:LNTH) with a buy citing the company's growth trajectory due to the the launch of Pylarify, a prostate-specific membrane antigen (PSMA. with suspected recurrence based on. PYLARIFY Injection is designed to detect prostate-specific membrane. Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. “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. , Sept. 0% from the prior year period. 54, as compared to $0. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. INDICATION. by year endNORTH BILLERICA, Mass. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. Eastern Time. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. , a Lantheus company. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. 6% and an increase of 25. 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. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 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. 17%. Worldwide revenue of $208. . The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. For men with prostate cancer, PYLARIFY. The. BEDFORD, Mass. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 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 (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 47, as compared to $0. 52%) were up 21. S. PYLARIFY identifies PSMA, the. , Sept. 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. Follow the PYLARIFY® injection with an intravenous flush of 0. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. . Lantheus Receives U. 52%) were up 21. April 29, 2022 07:07 ET | Source: 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. 1 million for the second quarter of 2021, representing an increase of 121. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Syntermed announces its appointment by Lantheus Holdings, Inc. GAAP net loss. §287(a). Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). 1 million for the third quarter 2021, representing an increase of 15. • Visually inspect the radiopharmaceutical solution. In the U. 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. 2 million for the third quarter 2022, compared to GAAP net loss of $13. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. 48 from the prior year period. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . , [18 F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. 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. 3. 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. 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. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. Lantheus Medical Imaging has received approval from the 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. 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 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. 6 million and $425. Contact information For media. BEDFORD, Mass. com. diagnostic radiopharmaceutical. S. The FDA approved the F 18-labeled prostate-specific membrane antigen (PSMA)–targeted positron emission tomography (PET) imaging agent 18F-DCFPyL (Pylarify) for use in prostate cancer, according to an announcement from the company responsible for the agent, Lantheus Holdings, Inc. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. 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. 3M as the prostate cancer diagnostic agent Pylarify added $143. May 16, 2022 at 8:00 AM EDT. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. com. Mid-cap Lantheus Holdings has been on a revenue growth spurt boosted by a new product called Pylarify, which helps detect prostate cancer in an imaging test. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. 0 is commercially available in the United States . Lantheus provides a broad. The Pylarify AI system is a deep learning algorithm that allows physicians to. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. , Nov. TechneLite net revenue was $24. $ 68. GAAP fully diluted earnings per share were $1. patents apply to our products: DEFINITY ® /DEFINITY. 5 million, representing 61. S. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 50 from the prior year period. 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. CC-BY-4. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. The merger agreement was first announced on October 2, 2019 . The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. 1 million for the fourth quarter and full year 2022, representing increases of 103. “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. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. Lantheus Holdings, Inc. The stock has been a big winner in 2022 thanks to the impressive growth racked up by recently launched imaging agent Pylarify. 9% Sodium Chloride Injection, USP. 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. PYLARIFY may be diluted with 0. 9% sodium chloride injection USP. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). Lantheus Holdings, Inc. S. Lantheus Holdings. “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. Lantheus Holdings, Inc. (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 Receives U. is the parent company of Lantheus Medical Imaging, Inc. PDF Version. to 6:00 p. 7% year-over-year, and progressed our. 50. Lantheus Receives U. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. 7 million for the second quarter 2023, representing an increase of 43. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. The Company’s second quarter 2022 GAAP net income was $43. GAAP. Our products have practical applications in oncology, cardiology and more. m. With 3 million men living with prostate cancer and more than 18. 1-800-299-3431. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. NORTH BILLERICA, Mass. “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 AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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. S. , [18 F]-DCFPyL was approved by the FDA in May of 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. 89 for the second quarter of 2022, representing an increase of approximately $0. Lastly, net cash provided by operating activities was $108. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). INDICATION. D. 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. 47, as compared to $0. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. PYLARIFY was approved by the U. • Assay the dose in a suitable dose calibrator prior to administration. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Read more about Lantheus Announces Top Rated Oral Presentation. 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. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. ET. m. 5 million, representing 61. , Nov. US Customer Service/Order PYLARIFY®. 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. 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. PYLARIFY PSMA - Where and when. S. 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. CAS Number: 1423758-00-2. , Sept. S. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. 4% from the prior year period. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. 0 million and $150. 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 says its technology can help improve the management of prostate cancer patients. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. NORTH BILLERICA, Mass. PYLARIFY® (piflufolastat F 18) Injection Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:. Lantheus Holdings, Inc. Food and Drug Administration in May 2021. 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. Please enter your ZIP code to locate the nearest imaging site that offers 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 for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Image source: The Motley Fool. Read More. It is the #1 PSMA PET Imaging. Phone: 1-800-964-0446. 4% from the prior year period ; GAAP net income of $61. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. 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. (the Company) (NASDAQ: LNTH), a company committed to“Lantheus is a demonstrated commercial leader in the field of radiopharmaceuticals. PYLARIFY (piflufolastat F18) injection. LinkedIn. S. 8% from the prior year period; GAAP net income of $94. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. m. Using PYLARIFY AI™ to locate PSMA-avid lesions and track changes over time, investigators were able to determine that the change in the automated PSMA scan. , CEO of POINT Biopharma. (LNTH) 1 Like. 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. 6 million for the fourth quarter of 2021, representing an increase of 103. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. Lantheus Holdings, Inc. PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. We have been thrilled with the response to PYLARIFY in the prostate cancer community, said Mary Anne Heino, President and Chief Executive Officer of Lantheus. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc.