” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 7 million in the same period last year. Intended for U. 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. 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. Deploy. 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. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. S. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. The Company’s second quarter 2022 GAAP net income was $43. 5 million, representing 61. S. David Crawford, M. GAAP net. In the U. , Nov. 0. Lantheus Receives U. 2 million, or $0. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. U. , Nov. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. C. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. is the parent company of Lantheus Medical Imaging, Inc. The Lantheus Protocol: Pylarify Growth May Slow The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . The company's. In the last reported quarter, the company’s earnings of 97 cents per share. 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. Read more about Lantheus Announces Top Rated Oral Presentation. BEDFORD, Mass. This indicates a strong confidence in Pylarify’s growth, even amidst new. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. , Sept. Lantheus Receives U. 1-800-299-3431. PYLARIFY may be diluted with 0. S. S. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 99 for the third quarter of 2022, representing an increase of approximately $0. 2 million for the fourth quarter and full year 2021, representing an increase of 37. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Product Uses . PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). Contact information For media. 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. TechneLite net revenue was $24. , [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. 1% over the. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. ” Prostate cancer is a common and usually slow-growing cancer. S. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. 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. PYLARIFY may be diluted with 0. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. 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. 0. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. is the parent company of Lantheus Medical Imaging, Inc. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). 0 is commercially available in the United States . Lantheus Holdings, Inc. S. Lantheus Receives U. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 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. (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 PYLARIFY AI data will be presented at the. This agent is similar to the Gallium-68 PSMA-11 agent which was approved in December 2020, except that it can be produced in much greater quantities and distrMarketBeat has tracked 5 news articles for Lantheus this week, compared to 5 articles on an average week. 86 for the third quarter 2022, compared to. and EXINI Diagnostics AB. – Paul Blanchfield, Chief Commercial Officer at Lantheus. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. The. 25 reported a year ago. Lantheus Receives U. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. Worldwide revenue of $300. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. NEW YORK, Feb. Worldwide revenue of $239. S. Lastly, net cash used in operating activities was $32. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. BEDFORD, Mass. 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. 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 outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. Purpose of this notice. 31 Mar, 2022, 09:00 ET. NORTH BILLERICA, Mass. 9% Sodium Chloride Injection USP. , a Lantheus company 331. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. The. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. PYLARIFY® may help detect metastases even when PSA levels are low. 8 million for the first quarter 2023, representing an increase of 44. is the parent company of Lantheus Medical Imaging, Inc. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. Lantheus expects their fully diluted adjusted earnings per share to be between $0. 2% for the week as of Friday afternoon,. S. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. 37. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. S. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. com. 52%) were up 21. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. ET. 4% from the prior year period; GAAP net income of $43. Pylarify is the largest growth driver for the company as it comprised 65% of. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. Lantheus Holdings, Inc. Morris MJ, Rowe SP, Gorin MA, et al. PYLARIFY PSMA - Where and when. (RTTNews) - Lantheus Holdings Inc. S. 7 million for the second quarter 2023, representing an increase of 43. 6 million to the ante. Nov 6, 2021, 2:00 p. 86 for the third quarter 2022, compared to. June 12, 2023 08:30 ET | Source: Lantheus Holdings. 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. PDF Version. Shares of Lantheus Holdings (LNTH-0. This was another terrific quarter for Lantheus. 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® is an imaging agent for PET/CT scans that uses a unique combination of a PSMA-targeted small molecule and the radioactive tracer 18 F to help your doctor make more informed treatment choices based on clear images. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. 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. , Nov. “The transaction leverages Lantheus’. Worldwide revenue of $129. 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. Melissa Downs. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. Lantheus Medical Imaging has received approval from the U. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 48 from the prior year period. 86 per fully diluted share, as compared to GAAP net loss of. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. , Progenics Pharmaceuticals, Inc. This other product, even though it was, I'll say, riding the wave of the momentum that. BEDFORD, Mass. 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. 97 for the first quarter of 2022, representing an increase of approximately $0. 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 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. Progenics Pharmaceuticals, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. S. 3% over the prior year. GAAP. In the U. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. PYLARIFY –Prostate Cancer Franchise Overview Paul Blanchfield, Chief Commercial Officer Etienne Montagut, Chief Business Officer Aseem Anand, VP of Digital Solutions PYLARIFY Key Opinion Leader Panel Moderator: Bela Denes, M. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. 5 million, representing 61. 1. 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. , [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. This is the first and final payment related to the CVRs and is in full satisfaction of Lantheus’ payment obligations related to the CVRs. Pylarify PET detected at least one positive lesion in at least one body region (bone, prostate bed, pelvic lymph node, other lymph nodes, or soft tissue) in 60% of these patients. The Company updates its guidance for the first quarter and full year 2023 is as follows: PYLARIFY revenues in 1H23 were $405m - up 82% year-on-year - so it seems clear that PYLARIFY revenues have substantially more growth potential - Lantheus' guidance for total revenues in 2023. Eastern, Monday - Friday © 2023 Lantheus. 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. Follow the PYLARIFY® injection with an intravenous flush of 0. In the last reported quarter, Lantheus earnings per share (EPS) of $1. 5 million for the first quarter 2023. D. 3% over the prior year. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. Find out why LNTH stock is a Strong Buy. Jul 28, 2021, 8:00 a. S. 3 million for the third quarter 2022, representing an increase of 134. With 3 million men living with prostate cancer and more than 18 million adults. , Progenics Pharmaceuticals, Inc. Based in North Billerica, Mass. 331 Treble Cove Road . m. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. Lantheus Receives U. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. Fax: 978-436-7296. 96 and $0. 9% Sodium Chloride Injection, USP. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. S. diagnostic radiopharmaceutical. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 2023 Annual Scan Potential Estimates 12. 4 million in the prior year period ; GAAP fully diluted net income per share of $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. 4 million. INDICATION. and EXINI Diagnostics AB. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. by year. 2 million, compared with $129. INDICATION. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. D. , [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. For $260m Lantheus secured rights to Point’s two most advanced radioligand therapeutic projects, one of which concerns prostate cancer and hits PSMA – the target for Pylarify and for two Lantheus development-stage therapeutics. 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. -1. 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. 52%) were up 21. In the U. Food and Drug Administration in May 2021. with suspected recurrence based on. 89 for the second quarter of 2022, representing an increase of approximately $0. 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 Holdings, Inc. ir@lantheus. Read More. 5 stocks we like better than LantheusNano-X reported $2. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. PYLARIFY AI deployment can be facilitated both as a secure web cloud application and as a local. 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. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. The approval covers the use of Lu177-PSMA-617 in patients who have metastatic prostate cancer that is hormone-resistant (also known as castrate-resistant) and whose tumors. This page is intended to serve as notice under 35 U. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. NEW YORK, Jan. 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. 4% from the prior year period ; GAAP net income of $61. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. PYLARIFY® [package insert]. United States of America . 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. Published online May 11, 2022. Please refer to the map below for the production site nearest you. Lantheus provides a broad. Product Uses: diagnostic radiopharmaceutical . Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. Residents Only. The creation of artificial high-performance photosynthetic assemblies with a tailorable antenna system to deliver absorbed solar energy to a photosynthetic reaction center,. by year endNORTH BILLERICA, Mass. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. , [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. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. 2 million for the third quarter 2022, compared to GAAP net loss of $13. 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. 1 million for the second quarter 2023, compared to GAAP net income of $43. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Email: [email protected] 04, 2021 07:00 ET | Source: Lantheus Holdings, Inc. About Lantheus Holdings, Inc. , CEO of POINT Biopharma. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. 9% Sodium Chloride Injection, USP. Lantheus Receives U. Melissa Downs Senior Director, Corporate Communications 646. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. PYLARIFY® (piflufolastat 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:. 9 million, up 33. 2 million and $935. , Progenics Pharmaceuticals, Inc. , a Lantheus company . Worldwide revenue of $208. PYLARIFY Injection is designed to detect prostate-specific membrane. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. BEDFORD, Mass. com. , Nov. 50 from the prior year period. Lantheus Holdings, Inc. 1M in 2022, following a 25% YoY decline, according to the. 8% from the prior year period; GAAP net income of $94. November 3, 2022 at 7:00 AM · 11 min read. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 8 billion tied up in biobucks. , [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. , Progenics Pharmaceuticals, Inc. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly available68. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Billerica, MA 01862 . 97 for the first quarter of 2022, representing an increase of approximately $0. 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. , Sept. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. • Calculate the necessary volume to administer based on calibration time and required dose. 3 million for the second quarter 2023. 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. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. Lantheus Holdings, Inc. 3. US Customer Service/Order PYLARIFY®. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. 7 million, compared with $101. In the U. §287(a). May 16, 2022 at 8:00 AM EDT. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. 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. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. • Visually inspect the radiopharmaceutical solution. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. GAAP net loss. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. (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. Greater Chicago Area. price-eps-surprise | Lantheus Holdings, Inc. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and. 33 for the second quarter 2023, compared. Outside U. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced it will present the following presentations at. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 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. . (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. 0% from the prior year period. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. Lantheus Holdings, Inc. 36%) Q3 2021 Earnings Call. Our products have practical applications in oncology, cardiology and more. In the U. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. PYLARIFY Injection is designed to detect prostate-specific membrane. Welcome to the Lantheus Third Quarter 2023 Financial Results. NORTH BILLERICA, Mass. Developed by Lantheus, PYLARIFY ® was recently approved by the U. 3M as the prostate cancer diagnostic agent Pylarify added $143. , a Lantheus company . The company reported Q4 adjusted EPS of $1. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. 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. CAS Number: 1423758-00-2. 3 million, compared with $102. 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. In patients with. Leadership provided initial guidance for FY2023 as well. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. “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. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 47, as compared to $0. 1 million, or $0. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. Assay the dose in a suitable dose calibrator prior to administration. "It's not like there is only one PSMA molecule that we can radiolabel," said Cameron Foster, director of theranostics at the University of California, Davis. Lantheus 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. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. 4. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. Lantheus Reports First Quarter 2023 Financial Results.