NORTH BILLERICA, Mass. 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. INDICATION. 48 from the prior year period. 3% from the prior year period. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. GAAP net. (the Company) (NASDAQ: LNTH), a company committed to“PYLARIFY AI has the potential to contribute meaningful insights to inform treatment selection and monitoring in prostate cancer. 2% from the prior year quarter due to. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy: Locally Recurrent or New/Progressive PCa: OSPREY COHORT B; Safety; CASE STUDIES; HOW TO USE PYLARIFY® REIMBURSEMENT AND AVAILABILITY; PYLARIFY AI™ PYLARIFY AI™ Overview; What Is PYLARIFY AI™? PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. On-site plant will produce. 50. 7 million for the third quarter 2023. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. , Nov. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. 0 million and $150. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. In the U. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of PSMA PET/CT scans. 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. Accessed May 11, 2022. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. PYLARIFY PSMA - Where and when. Lantheus Holdings, Inc. BEDFORD, Mass. 47, as compared to $0. and EXINI Diagnostics AB. 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. S. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Worldwide revenue of $321. diagnostic radiopharmaceutical. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 54, as compared to $0. ” Prostate cancer is a common and usually slow-growing cancer. This was another terrific quarter for Lantheus. NORTH BILLERICA, Mass. 5 million for the first 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. Strategic architect for the Uro-oncology franchise. 0 million and $150. BEDFORD, Mass. NEW YORK, Jan. NORTH BILLERICA, Mass. • Visually inspect the radiopharmaceutical solution. We reported revenue of $319. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. (LNTH) 1 Like. Pylarify accounted for $160. 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. 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 Holdings, Inc. 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:. The device provides general. 01. “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. For International Transportation. PYLARIFY Injection is designed to detect prostate-specific membrane. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. 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. m. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. Billerica, MA 01862 . NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. 7 million is being distributed to the holders. 8M of net sales while cardiovascular ultrasound enhancement. 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. 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. 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 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. Lantheus says its technology can help improve the management of prostate cancer patients. S. In the last reported quarter, the company’s earnings of 97 cents per share. Heino , President and Chief Executive Officer of Lantheus . Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. , Nov. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. CAS Number: 1423758-00-2. 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. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. 2% for the week as of Friday afternoon,. S. • Calculate the necessary volume to administer based on calibration time and required dose. 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 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. S. 9 million for the first quarter 2022, representing an increase of 125. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. 88 and earnings of $1. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. 1 million for the second quarter of 2021, representing an increase of 121. Worldwide revenue of $300. 8% from the prior year period. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. 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”). 3. Leadership provided initial guidance for FY2023 as well. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. While the company generated $527M in. Jul. 0% from the prior year 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. 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. (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. 2 million, compared with $129. Lantheus Holdings, Inc. "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. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 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 PYLARIFY. 9% Sodium Chloride Injection USP. 50 from the prior year period. Lantheus credited the revenue rise from increased sales for its Pylarify PSMA PET imaging agent, used to detect recurrent or metastatic prostate cancer, as well as increased use of its Definity. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. , a Lantheus company . Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. , VP, Medical Affairs E. S. June 12,. NORTH BILLERICA, Mass. We accelerated our growth. 4% from the prior year period. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for patients. Food and Drug Administration (FDA) has approved. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. S. 1M in 2022, following a 25% YoY decline, according to the. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. , a Lantheus company. 6 million worth of sales while DEFINITY contributed $63. The creation of artificial high-performance photosynthetic assemblies with a tailorable antenna system to deliver absorbed solar energy to a photosynthetic reaction center,. to 6:00 p. ET. 1 million for the third quarter 2021, representing an increase of 15. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. NORTH BILLERICA, Mass. , [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. by year endNORTH BILLERICA, Mass. (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. Lastly, net cash provided by operating activities was $108. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. 5 million, representing 61. Worldwide revenue of $263. Phone: 1-800-964-0446. Lantheus Holdings, Inc. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 1 million for the fourth quarter and full year 2022, representing increases of 103. Eastern Time. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. An FDA-cleared medical device software, PYLARIFY AI V1. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. DULLES, Va. 47, as compared to $0. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. 7 million, up 12. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. m. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. Lantheus Holdings, Inc. 4. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. 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. PYLARIFY (piflufolastat F18) injection. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. Pylarify is the largest growth driver for the company as it comprised 65% of. 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. 7 million, up 12. 4 million. 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. LNTH is expected to report second-quarter 2022 results on Jul 27. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. “In addition to FDA approval, inclusion in the guidelines. Since then, Lantheus' sales have more than doubled. BEDFORD, Mass. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 47, as compared to $0. In the U. 52%) were up 21. 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. 5 million, representing 61. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. 54. 29. 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. GAAP fully diluted earnings per share were $1. 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. 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. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 9% sodium chloride injection USP. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that the U. 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. “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. Now turning to cash flow. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. Lantheus Receives U. 3% over the prior. 45 and $0. 37, surpassing the consensus of $0. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. Lantheus Holdings, Inc. , a Lantheus company 331. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 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. “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. LNTH earnings call for the period ending June 30, 2021. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. S. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 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. Read more about Lantheus Announces Top Rated Oral Presentation. About Lantheus With more than 65 years of experience in delivering life. Find out why LNTH stock is a Strong Buy. 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’ 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. Lantheus Receives U. The Lantheus Protocol: Pylarify Growth May Slow The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. The company also received a CE marking in Europe for PYLARIFY AI. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. In the last reported quarter, Lantheus earnings per share (EPS) of $1. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. 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. , Sept. , [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. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. , a Lantheus company. 4% from the prior year period. S. 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. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. Shares of Lantheus Holdings (LNTH-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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent. About Lantheus With more than 65 years of experience in delivering life. The. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. , 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. 96 and $0. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. Jul 21, 2022 02:13PM EDT. The Lantheus Protocol: Pylarify Growth May Slow. 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. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 86 for the third quarter 2022, compared to. TechneLite net revenue was $24. C. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. S. North Billerica, MA: Progenics Pharmaceuticals, Inc. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. For men with prostate cancer, PYLARIFY. Greater Chicago Area. 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. Nov 6, 2021, 2:00 p. March 29, 2022 at 8:00 AM · 8 min read. Progenics Pharmaceuticals, Inc. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. 0. NORTH BILLERICA, Mass. 1-800-299-3431. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. May 4, 2023 at 7:00 AM · 10 min read. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. 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. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. ir@lantheus. Pylarify. 6 million and $425. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 1 million in the prior year period; GAAP fully diluted net income per share of $1. 1% and 119. is the parent company of Lantheus Medical Imaging, Inc. , Sept. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. 18F-DCFPyL is now the first. “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. 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. 9 mg ethanol in 0. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. PYLARIFY identifies PSMA, the. Worldwide revenue of $321. Pylarify is labeled with F-18 and homes in on PSMA, a protein that is overexpressed on the surface of more than 90% of. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. BEDFORD, Mass. 3% over the prior year. As the levels of PSA in your blood go up, a PYLARIFY PET/CT scan is better able to identify. as the first U. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. , [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. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. It is the #1 PSMA PET Imaging. Lantheus Reports Second Quarter 2023 Financial Results. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. 1 million for the third quarter of 2021, representing an increase of 134. Sanchez-Crespo A. 50 from the prior year period. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). GAAP net loss. 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. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. Melissa Downs Senior Director, Corporate Communications 646-975-2533 media@lantheus. “PYLARIFY has the potential to contribute meaningful and actionable information that can be used to personalize treatment plans in men with low PSA levels,” said Dr. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. NORTH BILLERICA, Mass. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 7 million for the second quarter 2023, representing an increase of 43. 3. 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. 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, compared with $101. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. #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 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. Worldwide revenue of $208. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). 7% year-over-year, and progressed our. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. 0. Worldwide revenue of $102. INDICATION. Lantheus Receives U. Pylarify. Fax: 978-436-7296. , a Lantheus company . (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. 2% from the prior year quarter due to. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. 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. The company reports earnings on November 3, with analysts expecting the company to top last year's results. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. S. In the U. and EXINI Diagnostics AB. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. 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. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. Syntermed announces its appointment by Lantheus Holdings, Inc. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. 3 million for the second quarter 2023. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. S. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. BEDFORD, Mass. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. Lantheus provides a broad. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. , Nov. Using PYLARIFY AI™ to locate PSMA-avid lesions and track changes over time, investigators were able to determine that the change in the automated PSMA scan. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. com. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Progenics Pharmaceuticals, Inc. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. S. 52%) were up 21.