by year endNORTH BILLERICA, Mass. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. ET. , Nov. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. Lantheus Holdings Inc. with suspected recurrence based on. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. In the U. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. . Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). 5 million for the first quarter 2023. Lantheus Holdings, Inc. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. 6 million and $425. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly availableLantheus delivered a BIG and welcome beat-and-raise quarter and shares were up as much as +20%, poking their nose over $71. 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. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. D. 45%. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. UAB Therapy Intensive Program – for Technologists. Melissa Downs. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. NORTH BILLERICA, Mass. Billerica, MA 01862 . In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. The company also received a CE marking in Europe for PYLARIFY AI. 47, as compared to $0. 29. 4 million in revenue, up 25% year over year, and a net loss of $11. In the U. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. PYLARIFY may be diluted with 0. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. 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 expects their fully diluted adjusted earnings per share to be between $0. 7 million in the same period last year. 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 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. GAAP fully diluted earnings per share were $1. Our products have practical applications in oncology, cardiology and more. 7 million, compared with $101. Lantheus Reports Second Quarter 2023 Financial Results. 50 from the prior year period. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. S. , VP, Medical Affairs E. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes. Today, we put the spotlight on Lantheus Holdings for the first time. 47, as compared to $0. 2 million and $935. • Dispose of any unused PYLARIFY in compliance with applicable regulations. 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’. US Customer Service/Order PYLARIFY®. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. 9% Sodium Chloride Injection, USP. com. An FDA-cleared medical device software, PYLARIFY AI V1. 5 million, representing 61. 9 mg ethanol in 0. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (RTTNews) - Lantheus Holdings Inc. . 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. “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. 9% sodium chloride injection USP. (LNTH) 1 Like. 8% from the prior year period; GAAP net income of $94. 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 (piflufolastat F18) injection. 2. “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. U. -1. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. “Being selected by Lantheus to partner to administer the first dose of PYLARIFY is an honor, and it’s humbling to know that GenesisCare will be potentially helping men with prostate cancer, while improving access to high-quality care for our patients. , a Lantheus company . S. 54. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. PET/CT. “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. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . But most. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 1M in 2022, following a 25% YoY decline, according to the. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. For men with prostate cancer, 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 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 agent. 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. Director, Corporate Communications. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. Worldwide revenue of $208. Assay the dose in a suitable dose calibrator prior to administration. S. Lantheus Holdings. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging. 4% from the prior year period. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. United States of America . Find out why LNTH stock is a Strong Buy. This means that a negative PYLARIFY PET/CT scan does not rule out that you have prostate cancer, and a positive PYLARIFY PET/CT scan does not confirm that you have prostate cancer. 15. We obtained FDA approval for and successfully launched PYLARIFY®Lantheus will fund the all-cash license of exclusive worldwide rights, excluding certain territories 1, for PNT2002 and PNT2003 with cash on Lantheus’ balance sheet and committed financing. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Eastern Time. S. The program is available to HCPs who have completed the PYLARIFY® Reader Training. In the last reported quarter, the company’s earnings of 97 cents per share. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. Worldwide revenue of $129. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. 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®. 86 per fully diluted share, as compared to GAAP net loss of. Lantheus Announces Presentations Featuring PYLARIFY AI at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12, 2023 BEDFORD, Mass. 50. 4. “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. NORTH BILLERICA, Mass. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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 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. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. 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. 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. May 4, 2023 at 7:00 AM · 10 min read. Read more about Lantheus Announces Top Rated Oral Presentation. (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. 99 for the third quarter of 2022, representing an increase of approximately $0. May 16, 2022 at 8:00 AM EDT. 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. 66 from the prior year period. 1. Now turning to cash flow. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. 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. NORTH BILLERICA,. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. 7 million for the second quarter 2022, representing an increase of 121. 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. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. 1 million for the second quarter 2022, compared to GAAP net loss of $26. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. Melissa Downs Senior Director, Corporate Communications 646. “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. 52%) were up 21. Shares of Lantheus Holdings (LNTH-0. May 16, 2022 at 8:00 AM EDT. 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. 9% Sodium Chloride Injection, USP. -1. Pylarify is the largest growth driver for the company as it comprised 65% of. S. m. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. and EXINI Diagnostics AB. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 47, as compared to $0. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 331 Treble Cove Road . Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. In patients with. The Lantheus Protocol: Pylarify Growth May Slow. as the first U. com. Follow. Since then, Lantheus' sales have more than doubled. 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. diagnostic radiopharmaceutical. 6 million for the fourth quarter of 2021, representing an increase of 103. 97 for the first quarter of 2022, representing an increase of approximately $0. 0. 4. BEDFORD, Mass. Under. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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 with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. 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. 3% from the prior year period. 0. (the Company) ( NASDAQ: LNTH ), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced it will present the following. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. Food and Drug Administration (FDA) has approved. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including PYLARIFY. GAAP. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 3. , Sept. 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. 3 million for the third quarter 2022, representing an increase of 134. PDF Version. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. U. INDICATION. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. The Company’s third quarter 2022 GAAP net income was $61. BEDFORD, Mass. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. S. “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. Purpose of this notice. 2% for the week as of Friday afternoon,. 1 million for the third quarter 2021, representing an increase of 15. Leadership provided initial guidance for FY2023 as well. Lantheus Holdings, Inc. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. “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 Holdings, Inc. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. S. The. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. S. Worldwide revenue of $321. 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. Lastly, net cash provided by operating activities was $116. • Assay the dose in a suitable dose calibrator prior to administration. Lantheus Holdings, Inc. BEDFORD, Mass. 1 million for the fourth quarter and full year 2022, representing increases of 103. DULLES, Va. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancer. S. May 27, 2021 — Today, the FDA approved the 18F-DCFPyL PSMA PET imaging agent (also known as “PyL” for short or by its trade name “PYLARIFY”). Lantheus 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. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. 1. Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer. 7 million for the third quarter 2023. Shares of Lantheus Holdings (LNTH-0. 9% Sodium Chloride Injection USP. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus Receives U. 3 million for the third quarter 2022, representing an increase of 134. S. LNTH earnings call for the period ending June 30, 2021. 4% from the prior year period. 5 stocks we like better than LantheusNano-X reported $2. Melissa Downs Senior Director, Corporate Communications 646-975-2533 media@lantheus. Lantheus Holdings, Inc. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). S. , Progenics Pharmaceuticals, Inc. 3. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. 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:. PYLARIFY is the only PSMA-imaging agent that is widely available through a diverse, multi-partner F18 distributor network, ensuring convenient and reliable supply MARKET ACCESS More than 90% of covered lives have access to PSMA PET with PYLARIFY1 UTILIZATION PYLARIFY is the #1 ordered PSMA PET imaging agent in the U. Follow the PYLARIFY® injection with an intravenous flush of 0. 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. S. 0 million and $150. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. This is the first and final payment related to the CVRs and is in full satisfaction of Lantheus’ payment obligations related to the CVRs. Strategic architect for the Uro-oncology franchise. , [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. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. But. 9 million for the first quarter 2022, representing an increase of 125. The program is available to HCPs who have completed the PYLARIFY® Reader Training. (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 (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. Lantheus says its technology can help improve the management of prostate cancer patients. , CEO of POINT Biopharma. 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. patents apply to our products: DEFINITY ® /DEFINITY. “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. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. 8% from the prior year period. Lantheus Receives U. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. S. , Nov. 2% for the week as of Friday afternoon,. Sanchez-Crespo A. Lantheus Receives U. Please refer to the map below for the production site nearest you. m. 61 per fully diluted share, as compared to GAAP net loss. PYLARIFY® IS UNIQUE. 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 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. D. 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. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. ET. 1 million for the second quarter of 2021, representing an increase of 121. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. Eastern, Monday - Friday © 2023 Lantheus. 12. and EXINI Diagnostics AB. NORTH BILLERICA, Mass. 8 billion tied up in biobucks. Phone: 1-800-964-0446. is the parent company of Lantheus Medical Imaging, Inc. This page is intended to serve as notice under 35 U. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. com. , Nov. Read More. 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. 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. S. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. 978-671-8842. 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. Melissa Downs Senior Director, Corporate Communications 646. , a Lantheus company 331. com. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus provides a broad. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. 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. 0 is commercially available in the United States . For men with prostate cancer,. $ 68. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. U. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. Quote. Accessed May 11, 2022. , a Lantheus company. with suspected recurrence based on. PYLARIFY PSMA - Where and when. , Progenics Pharmaceuticals, Inc. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. , Sept. Welcome to the Lantheus Third Quarter 2023 Financial Results. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. June 12, 2023 at 8:30 AM EDT. 48 from the prior year period. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. Lantheus Holdings, Inc. 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. 5 million for the first quarter 2023. 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. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. 28 May, 2021, 07:00 ET. 01. 9% Sodium Chloride Injection USP. 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. S. INDICATION. m. is the parent company of Lantheus Medical Imaging, Inc. BEDFORD, Mass. 9% Sodium Chloride Injection, USP. , [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. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. 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. 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. Pylarify. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Q4 adjuested EPS grew +448% Y/Y to $1. 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. 18F-DCFPyL is now the first. #Lantheus was thrilled to be a Gold Sponsor of the 16th Clinical Trials on Alzheimer’s Disease conference (CTAD), which took place from Oct 24-27 in Boston! It was a wonderful opportunity to connect with our partners in the industry and academia who are using our investigational Tau PET imaging agent in their clinical trials. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 6 million worth of sales while DEFINITY contributed $63. April 29, 2022 07:07 ET | Source: Lantheus Holdings, Inc. 96 and $0. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. 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. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. 86 for the third quarter 2022, compared to. Lantheus Holdings, Inc. and EXINI Diagnostics AB. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. The company expects to. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. 7% year-over-year, and progressed our. Lantheus Holdings, Inc.