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 reported Q4 adjusted EPS of $1. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. 15. The company also received a CE marking in Europe for PYLARIFY AI. LNTH earnings call for the period ending June 30, 2021. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. , CEO of POINT Biopharma. S. The Lantheus Protocol: Pylarify Growth May Slow. 61 per fully diluted share, as compared to GAAP net loss. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. In patients with. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Residents Only. Lantheus Holdings, Inc. On-site plant will produce. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. 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. 7 million for the third quarter 2023. 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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. 37, surpassing the consensus of $0. Eastern Time. PYLARIFY may be diluted with 0. 8 million for the first quarter 2023, representing an increase of 44. Coordination of care. 33 for the second quarter 2023, compared. -1. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. 9% Sodium Chloride Injection USP. “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. Worldwide revenue of $208. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 7 million in the same period last year. Lantheus Holdings, Inc. This indicates a strong confidence in Pylarify’s growth, even amidst new. S. by year. 0% from the prior year period. prostate cancer community and are likely to have contributed to the top. 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. 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. 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. Jul 28, 2021, 8:00 a. 5 million for the first quarter 2023. 4% from the prior year period. 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. , [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. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud to. 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. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. 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:. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. BEDFORD, Mass. , Nov. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. is the parent company of Lantheus Medical Imaging, Inc. S. – Paul Blanchfield, Chief Commercial Officer at Lantheus. February 16, 2023 at 8:30 AM EST. October 19, 2023. 3 million, compared with $102. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. The PyLAM is the primary customer facing Lantheus Holdings professional tasked with education of the Prostate Cancer medical referral community on PyLARIFY and the cultivation of productive customer relationships to include HCPs, Advanced Practice Providers, Nurses, Pharmacists, Department Administrators and other key medical and. The company is well-positioned to generate substantial free cash flow The cash flow statement provides a detailed overview of the cash inflows and outflows of a company over a specified period. 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. Mark Kinarney. Lantheus Holdings, Inc. S. GAAP fully diluted earnings per share were $1. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. Purpose of this notice. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. 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”). COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. Lantheus’ product, PYLARIFY ® (piflufolastat F 18) injection, is a radioactive diagnostic agent indicated for PET imaging of PSMA positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and/or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Billerica, MA 01862 . Lantheus Holdings, Inc. 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. 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. Nov 6, 2021, 2:00 p. patents apply to our products: DEFINITY ® /DEFINITY. S. This sample claim form is only an example. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. 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. Published online May 11, 2022. 88 and earnings of $1. ET. 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. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. “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. 12. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 1 million for the second quarter of 2021, representing an increase of 121. 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. , [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. S. Visit Investor Site. Strategic architect for the Uro-oncology franchise. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. For men with prostate cancer, PYLARIFY. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. 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. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 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 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. PDF Version. 4 million in revenue, up 25% year over year, and a net loss of $11. NORTH BILLERICA, Mass. 6 million to the ante. The company reports earnings on November 3, with analysts expecting the company to top last year's results. Product Uses . FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly available68. 37, while. United States of America . FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly available Lantheus delivered a BIG and welcome beat-and-raise quarter and shares were up as much as +20%, poking their nose over $71. 0. 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 are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. 48 from the prior year period. com. NORTH BILLERICA, Mass. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis. The. Lantheus Holdings, Inc. GAAP net. Contact information For media. “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. “In addition to FDA approval, inclusion in the guidelines. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. 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. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging. GAAP net. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 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. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. 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. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. In the U. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. Find out why LNTH stock is a Strong Buy. 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 . PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancerNORTH BILLERICA, Mass. D. Lantheus Holdings, Inc. Sanchez-Crespo A. In the U. istering PYLARIFY. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. Worldwide revenue of $239. 31 Mar, 2022, 09:00 ET. "There are several, and there will be new ones down the. , Nov. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. Pylarify is an injectable agent that helps highlight prostate cancer under a PET scan. is the parent company of Lantheus Medical Imaging, Inc. 54. (NASDAQ:NASDAQ:LNTH) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ETCompany ParticipantsMary Anne Heino – President and Chief Executive Officer Mark. Melissa Downs Senior Director, Corporate Communications 646. D. 2 million for the fourth quarter and full year 2021, representing an increase of 37. 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 global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. 8 million for the first quarter 2023, representing an increase of 44. PDF Version. 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 Holdings, Inc. , [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. Worldwide revenue of $129. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. 978-671-8842. 3. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. ET. m. , Professor of Urology, University of California San DiegoLantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 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. , a Lantheus company. com. Lantheus Reports First Quarter 2023 Financial Results. 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. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. 7 million is being distributed to the holders. Jul. #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. Since then, Lantheus' sales have more than doubled. with suspected recurrence based on. 47, as compared to $0. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. North Billerica, MA: 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. June 12, 2023 08:30 ET | Source: Lantheus Holdings. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 3% over the prior year. Lantheus Holdings. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Lantheus Original Approval date: May 26, 2021. 99 for the third quarter of 2022, representing an increase of approximately $0. Lantheus Receives U. Outside U. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. S. Our products have practical applications in oncology, cardiology and more. NEW YORK, Jan. PYLARIFY Injection is designed to detect prostate-specific membrane. 3. This sample claim form is only an example. , [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. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. An FDA-cleared medical device software, PYLARIFY AI V1. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Phone: 1-800-964-0446. 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. 7 million, up 12. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology 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. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. NORTH BILLERICA, Mass. Melissa Downs Senior Director, Corporate Communications 646. NORTH BILLERICA, Mass. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. price-eps-surprise | Lantheus Holdings, Inc. 9% Sodium Chloride Injection, USP. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. 86 for the third quarter 2022, compared to. 1. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. com. , VP, Medical Affairs E. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 50 from the prior year period. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023, with the vast majority of our sequential growth driven by our existing accounts. com. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 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 program is available to HCPs who have completed the PYLARIFY® Reader Training. News release. com. INDICATION. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. This other product, even though it was, I'll say, riding the wave of the momentum that. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. “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. 4% from the prior year period ; GAAP net income of $61. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. ,. 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’ 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. In the U. 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. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. Eastern Time. 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. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. Lantheus Receives U. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. 1 million in the prior year period; GAAP fully diluted net income per share of $1. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. ” Prostate cancer is a common and usually slow-growing cancer. DULLES, Va. Lantheus provides a broad portfolio of products, including PYLARIFY. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). S. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. U. NORTH BILLERICA, Mass. 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. Read more about Lantheus Announces Top Rated Oral Presentation. 4% from the prior year period ; GAAP net income of $61. 1M in 2022, following a 25% YoY decline, according to the. The program is available to HCPs who have completed the PYLARIFY® Reader Training. LinkedIn. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 99 for the third quarter of 2022, representing an increase of approximately $0. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 9% Sodium Chloride Injection, USP. 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. PYLARIFY® Peer-to-Peer Reader Assistance Program is a complementary program to the PYLARIFY® Reader Training that provides guidance and assistance to healthcare providers on how to accurately read and interpret PYLARIFY® scans. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. The. This is an increase of 200% compared to the previous 30 days. The following U. 8% from the prior year period; GAAP net income of $94. 2% for the week as of Friday afternoon,. 1-800-299-3431. com. 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. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 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. Lantheus provides a broad. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. 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. 7 million for the second quarter 2022, representing an increase of 121. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. , a Lantheus company. 2023 Annual Scan Potential Estimates 12. Image source: The Motley Fool. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. 2 million for the third quarter 2022, compared to GAAP net loss of $13. The PyLAM is the primary customer facing Lantheus Holdings professional tasked with education of the Prostate Cancer medical referral community on PyLARIFY and the cultivation of productive customer relationships to include HCPs, Advanced Practice Providers, Nurses, Pharmacists, Department Administrators and other key medical and. Progenics Pharmaceuticals, Inc. 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. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. Shares of Lantheus Holdings (LNTH-0. com. 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. 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. NORTH BILLERICA, Mass. 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. 17%. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 96 and $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. Progenics Pharmaceuticals, Inc. The FDA just recently approved the PSMA (piflfolastat F 18) scan. 4% from the prior year period. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. Nov 2014 - Sep 2017 2 years 11 months. 97 for the first quarter of 2022, representing an increase of approximately $0. Lantheus Holdings, Inc.