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. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA). Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men. Lantheus acquired Pylarify via its June 2020 merger with Progenics, a pharmaceutical company. Mark Kinarney. ,. 0 million and $150. 24%) Q2 2021 Earnings Call. 9% sodium chloride injection USP. Coordination of care. (the “Company”) (NASDAQ: LNTH), an established leader and fully. 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. 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. Shares of Lantheus Holdings (LNTH-0. Lantheus Receives U. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. , a Lantheus company . March 29, 2022 at 8:00 AM · 8 min read. It will need to spend additional. 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. LNTH earnings call for the period ending June 30, 2021. (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. “This. 47, as compared to $0. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. With 3 million men living with prostate cancer and more than 18 million adults. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 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. and Progenics Pharmaceuticals, Inc. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. Jul 28, 2021, 8:00 a. 3 million for the third quarter 2022, representing an increase of 134. S. Jul 21, 2022 02:13PM EDT. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 3% from the prior year period. The program is available to HCPs who have completed the PYLARIFY® Reader Training. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. Assay the dose in a suitable dose calibrator prior to administration. PYLARIFY may be diluted with 0. S. NORTH BILLERICA,. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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. Welcome to the Lantheus Third Quarter 2023 Financial Results. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. BEDFORD, Mass. PYLARIFY® may help detect metastases even when PSA levels are low. GAAP net loss. For International Transportation. Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. This indicates a strong confidence in Pylarify’s growth, even amidst new. This other product, even though it was, I'll say, riding the wave of the momentum that. 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. S. Morris MJ, Rowe SP, Gorin MA, et al. S. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. 1 million, or $0. 37, while. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. , [18 F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. “Today marks an important day for Lantheus and Progenics. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. S. Worldwide revenue of $321. 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. NORTH BILLERICA, Mass. and EXINI Diagnostics AB. 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. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 8 billion tied up in biobucks. S. Lantheus Holdings, Inc. Follow the PYLARIFY® injection with an intravenous flush of 0. with suspected recurrence based on. 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. , Nov. is the parent company of Lantheus Medical Imaging, Inc. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. Lastly, net cash provided by operating activities was $116. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 6 million for the fourth quarter of 2021, representing an increase of 103. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly availableLantheus delivered a BIG and welcome beat-and-raise quarter and shares were up as much as +20%, poking their nose over $71. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. The results. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). 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. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. • Dispose of any unused PYLARIFY in compliance with applicable regulations. 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. Worldwide revenue of $321. 8 million, compared to a loss of $21. 1 million in the prior year period; GAAP fully diluted net income per share of $1. This page is intended to serve as notice under 35 U. 331 Treble Cove Road . (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. Visit Investor Site. 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. The. 0 million and $150. GAAP. “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. GAAP fully diluted earnings per share were $1. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the 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 agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. 88 and earnings of $1. 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 is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging. PDF Version. Published online May 11, 2022. S. • Visually inspect the radiopharmaceutical solution. 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. 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. 2 million for the third quarter 2022, compared to GAAP net loss of $13. S. D. 9% Sodium Chloride Injection, USP. Lantheus Holdings, Inc. 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. For the full year 2022, Lantheus forecasts PYLARIFY to be in a range of $300M to $325M and their. Lantheus Original Approval date: May 26, 2021. US Customer Service/Order PYLARIFY®. to 6:00 p. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. Sanchez-Crespo A. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. CAS Number: 1423758-00-2. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. , a Lantheus company . United States of America . (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. 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 (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the. NORTH BILLERICA, Mass. 5 million for the first quarter 2023. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. 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 was founded in 1956 and formerly owned by Bristol Myers. ET. 9% Sodium Chloride Injection, USP. 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. 2 million and $935. 2% for the week as of Friday afternoon,. While the company generated $527M in. 3M as the prostate cancer diagnostic agent Pylarify added $143. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. com. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men. PYLARIFY works with PET/CT technology to produce a combined PET/CT scan that enables the reader of the PET/CT scan to detect and locate the disease. 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. But most. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. by year endNORTH BILLERICA, Mass. The program is available to HCPs who have completed the PYLARIFY® Reader Training. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA. 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. 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 Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 5 stocks we like better than LantheusNano-X reported $2. PET/CT. “We believe that PYLARIFY AI could enhance the efficient integration of PSMA PET/CT into clinical practice and will be. PYLARIFY AI deployment can be facilitated both as a secure web cloud application and as a local. The following U. 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. , Sept. 2% for the week as of Friday afternoon,. 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:. NORTH BILLERICA, Mass. 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. and EXINI Diagnostics AB. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. PYLARIFY is used along with positron emission tomography (PET) imaging for men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. , Nov. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. 45%. (the Company) (NASDAQ: LNTH), a company committed to“PYLARIFY AI has the potential to contribute meaningful insights to inform treatment selection and monitoring in prostate cancer. Lantheus 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. “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. and EXINI Diagnostics AB and anWorldwide revenue of $223. , [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. disease. 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. In the U. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. 3% over the prior. by year. 4% from the prior year period. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 [email protected] has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. Image source: The Motley Fool. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. 3% over the prior year. NORTH BILLERICA, Mass. 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. Lantheus Holdings, inc ( LNTH 2. 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”). TechneLite net revenue was $24. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. NORTH BILLERICA, Mass. 48 from the prior year period. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. 86 for the third quarter 2022, compared to. com. NEW YORK, Jan. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. 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. 9% Sodium Chloride Injection USP. INDICATION. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. NORTH BILLERICA, Mass. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Our products have practical applications in oncology, cardiology and more. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. 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. In 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 agent PYLARIFY, to potentially transform. S. Pylarify is an injectable agent that helps highlight prostate cancer under a PET scan. 5 million for the first quarter 2023. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the. 7 million for the second quarter 2023, representing an increase of 43. Lantheus Holdings, Inc. PYLARIFY Injection is designed to detect prostate-specific membrane. 6 million for the fourth quarter of 2021, representing an increase of 103. Under. 25 reported a year ago. In the U. S. Assay the dose in a suitable dose calibrator prior to administration. Leadership provided initial guidance for FY2023 as well. The FDA just recently approved the PSMA (piflfolastat F 18) scan. 9 million for the first quarter 2022, representing an increase of 125. , a Lantheus company. 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. Minimum 15 minutes delayed. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. com. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. 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. 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. 1 million for the fourth quarter and full year 2022, representing increases of 103. Billerica, MA 01862 . Lantheus Holdings, Inc. BEDFORD, Mass. But most. S. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. Contact information For media. 7 million is being distributed to the holders. • Calculate the necessary volume to administer based on calibration time and required dose. m. 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. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. , [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. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. 33 for the second quarter 2023, compared. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. INDICATION. 37. 4% from the prior year period ; GAAP net income of $61. US Customer Service/Order PYLARIFY®. Pylarify is the largest growth driver for the company as it comprised 65% of. 96 and $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. #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. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. PYLARIFY® IS UNIQUE. 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 to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. The company also received a CE marking in Europe for PYLARIFY AI. 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. 5 million, representing 61. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. Worldwide revenue of $102. May 16, 2022 at 8:00 AM EDT. 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. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. m. 4% from the prior year period. Develop and deploy marketing strategies to drive ROI, sales and margin. LNTH is expected to report second-quarter 2022 results on Jul 27. BEDFORD, Mass. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. 5 million, representing 61. , Nov. S. 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. , VP, Medical Affairs E. NORTH BILLERICA, Mass. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. • Dispose of any unused PYLARIFY in compliance with applicable regulations. "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. 6% and an increase of 25. S. com. DEFINITY in our in-house manufacturing facility; (v) our ability to successfully launch PYLARIFY AI as a commercial product; (vi) the continuing impact of the global COVID-19 pandemic on our business, supplyPhysicians and staff can use this resource to streamline access and reimbursement for PYLARIFY® (piflufolastat F 18) injection for appropriate patients. On-site plant will produce. May 16, 2022 at 8:00 AM EDT. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. PYLARIFY (piflufolastat F18) injection. Lantheus provides a broad portfolio of products, including PYLARIFY. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 331 Treble Cove Road . 3. For men with prostate cancer, PYLARIFY. 15. Syntermed announces its appointment by Lantheus Holdings, Inc. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. The merger agreement was first announced on October 2, 2019 . Lantheus Medical Imaging has received approval from the U. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. 52%) were up 21. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. Based in North Billerica, Mass. The. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. 8M of net sales while cardiovascular ultrasound enhancement. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. It is used to determine the presence or absence of recurrent or metastatic prostate cancer. 29. with suspected recurrence based on. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 1. 97 for the first quarter of 2022, representing an increase of approximately $0. In the U. Melissa Downs Senior Director, Corporate Communications 646. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, 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 availableEven 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. 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. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 3 million for the third quarter 2022, representing an increase of 134. 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 on Thursday reported Q4 adjusted net income of $1. 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. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. 66 from the prior year period. Pylarify. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. CC-BY-4. BEDFORD, Mass. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. 5 million, representing 61. 4% from the prior year period ; GAAP net income of $61. 7 million for the third quarter 2023. About Lantheus With more than 65 years of experience in delivering life. His confidence is backed by Lantheus’s Q3 results which exceeded Street expectations, largely due to the continued strength of their product, Pylarify, and their Precision Diagnostics segment. , June 12, 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. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. . , a Lantheus company 331. Eastern Time. ” Prostate cancer is a common and usually slow-growing cancer. m. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. 0 is commercially available in the United States . m. NORTH BILLERICA, Mass. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.