Worldwide revenue of $208. Melissa Downs Senior Director, Corporate Communications 646. Lantheus Receives U. , a Lantheus company. 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. 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. 88 and earnings of $1. 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. 4 million in revenue, up 25% year over year, and a net loss of $11. Worldwide revenue of $129. As part of the agreement with Novartis, Lantheus will provide PYLARIFY for the selection of patients with prostate cancer and Novartis will provide all PYLARIFY related clinical imaging data to Lantheus. 25 reported a year ago. PDF. , Progenics Pharmaceuticals, Inc. 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. 5 million, representing 61. Contacts: Mark Kinarney Vice President, Investor Relations978-671-8842 [email protected] will provide further details on the PYLARIFY launch to date in a few minutes, but I am thrilled that less than one year after we commenced our launch, more than 30,000 men have been imaged. (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. NORTH BILLERICA,. 2 million, compared with $129. 9% Sodium Chloride Injection, USP. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. 9 mg ethanol in 0. (the Company) (NASDAQ: LNTH), a company committed to“Lantheus is a demonstrated commercial leader in the field of radiopharmaceuticals. BEDFORD, Mass. S. “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. 99 for the third quarter of 2022, representing an increase of approximately $0. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. , Nov. 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. . 5 stocks we like better than LantheusNano-X reported $2. 3. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. 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. 9% Sodium Chloride Injection USP. is the parent company of Lantheus Medical Imaging, Inc. 2 million and $935. is the parent company of Lantheus Medical Imaging, Inc. (NASDAQ:NASDAQ:LNTH) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ETCompany ParticipantsMary Anne Heino – President and Chief Executive Officer Mark. May 4, 2023 at 7:00 AM · 10 min read. 1% over the. Minimum 15 minutes delayed. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. 01. , VP, Medical Affairs E. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform the way that clinicians manage and treat prostate cancer,” said Jean-Claude Provost, MD, Interim Chief Medical Officer, Lantheus. , May 28, 2021 /PRNewswire/ -- SOFIE, an established Radiopharmaceutical Contract Manufacturing Organization and GMP radiopharmacy network, will be commercially. Lantheus Holdings, Inc ( LNTH 0. 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. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. 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. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. “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. and EXINI Diagnostics AB. News release. S. 31 Mar, 2022, 09:00 ET. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 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 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 million, up 33. , [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. 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. U. 0% from the prior year period. , a Lantheus company . by year endNORTH BILLERICA, Mass. Lastly, net cash provided by operating activities was $116. D. 61 per fully diluted share, as compared to GAAP net loss. David Crawford, M. “Lantheus delivered another strong quarter and full year, highlighted by revenue performance which increased 38% and 25%, respectively,” said Mary Anne Heino, President and CEO. In 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. diagnostic radiopharmaceutical. 3% over the prior year. 47, as compared to $0. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Greater Chicago Area. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 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. We accelerated our growth. 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. 6 million and $425. The Company’s third quarter 2022 GAAP net income was $61. 1 million for the second quarter of 2021, representing an increase of 121. 24%) Q2 2021 Earnings Call. 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. INDICATION. 99 for the third quarter of 2022, representing an increase of approximately $0. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. 8% from the prior year period; GAAP net income of $94. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting September 1, 2023 at 8:30 AM EDT BEDFORD, Mass. BEDFORD, Mass. 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. , a Lantheus company . PDF Version. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. 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. PYLARIFY seems to be affected by the amount (level) of PSA in your blood. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Lastly, net cash provided by operating activities was $116. Lantheus Holdings, Inc. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. 12. Lantheus Receives U. Contact information For media. 97 for the first quarter of 2022, representing an increase of approximately $0. Billerica, MA 01862 . 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. 0. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. We reported revenue of $319. While the company generated $527M in. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. In the U. 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. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. Follow. Pylarify. 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. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. . , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. 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. 331 Treble Cove Road . Follow the PYLARIFY® injection with an intravenous flush 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. 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. PYLARIFY AI deployment can be facilitated both as a secure web cloud application and as a local. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. , CEO of POINT Biopharma. 7 million, up 12. Melissa Downs Senior Director, Corporate Communications 646. Lantheus provides a broad. PYLARIFY may be diluted with 0. Customer Service: 1-800-299-3431: Hours: 7:30 a. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. 3. With 3 million men living with prostate cancer and more than 18. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Lantheus provides a broad portfolio of products, including PYLARIFY. NORTH BILLERICA, Mass. Pylarify accounted for $160. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. Follow the PYLARIFY® injection with an intravenous flush of 0. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Lantheus says its technology can help improve the management of prostate cancer patients. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. S. 37. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. PYLARIFY is a. Developed by Lantheus, PYLARIFY ® was recently approved by the U. 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 . In the U. 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. 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. Read more about Lantheus Announces Top Rated Oral Presentation. NORTH BILLERICA,. (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. S. Lastly, net cash used in operating activities was $32. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. Worldwide revenue of $300. S. Lantheus Holdings. 4% from the prior year period ; GAAP net income of $61. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. 3. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. (LNTH) 1 Like. Eastern, Monday - Friday © 2023 Lantheus. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. 5 million for the first quarter 2023. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. It will need to spend additional. com. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. We obtained FDA approval for and successfully launched PYLARIFY®Lantheus will fund the all-cash license of exclusive worldwide rights, excluding certain territories 1, for PNT2002 and PNT2003 with cash on Lantheus’ balance sheet and committed financing. 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. In. 9% Sodium Chloride Injection, USP. S. 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. 6 million to the ante. "There are several, and there will be new ones down the. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. Lantheus Reports First Quarter 2023 Financial Results. , Progenics Pharmaceuticals, Inc. 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. 89 for the second quarter of 2022, representing an increase of approximately $0. Lantheus también está trabajando en el desarrollo de productos para otros tipos de cáncer, como los tumores neuroendocrinos, y en el diagnóstico y estadificación de la. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. But most. as the first U. S. June 12, 2023 08:30 ET | Source: Lantheus Holdings. Lantheus Holdings, Inc. m. 8 million for the first quarter 2023, representing an increase of 44. 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. S. Coordination of care. com. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. 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. 86 per fully diluted share, as compared to GAAP net loss of. BEDFORD, Mass. But. 00. PYLARIFY (piflufolastat F18) injection. LinkedIn. S. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 3 million for the third quarter 2022, representing an increase of 134. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. 1. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. , Sept. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. 3 million, compared with $102. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). Lantheus Holdings, Inc. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). 3% over the prior. “This. PDF Version. Lantheus Holdings, Inc. (RTTNews) - Lantheus Holdings Inc. PYLARIFY® [package insert]. 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. 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. 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. Billerica, MA 01862 . 48 from the prior year period. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. 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. PYLARIFY PSMA - Where and when. Lantheus Holdings, Inc. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. Phone: 1-800-964-0446. 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. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. Lantheus Reports Second Quarter 2023 Financial Results. PYLARIFY success leads to maximum payment in first yearBEDFORD, Mass. Lantheus Receives U. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. S. 5 million for the first quarter 2023. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. 6% and an increase of 25. Melissa Downs Senior Director, Corporate Communications 646. Eastern Time. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. 50 from the prior year period. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. We have been thrilled with the response to PYLARIFY in the prostate cancer community, said Mary Anne Heino, President and Chief Executive Officer of Lantheus. 8% from the prior year period. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud to. 2 million for the third quarter 2022, compared to GAAP net loss of $13. 4. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. CC-BY-4. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 0 is commercially available in the United States . 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. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancerNORTH BILLERICA, Mass. 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. 54, as compared to $0. 45%. 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. INDICATION. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. S. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. 9% Sodium Chloride Injection, USP. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. S. PYLARIFY is the only PSMA-imaging agent that is widely available through a diverse, multi-partner F18 distributor network, ensuring convenient and reliable supply MARKET ACCESS More than 90% of covered lives have access to PSMA PET with PYLARIFY1 UTILIZATION PYLARIFY is the #1 ordered PSMA PET imaging agent in the U. 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. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus Holdings, Inc. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. All rights reserved. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. PYLARIFY identifies PSMA, the. Third quarter operating cash. , [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. 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. with suspected recurrence based on. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 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. (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. 1M in 2022, following a 25% YoY decline, according to the. PYLARIFY may be diluted with 0. 3 million for the second quarter 2023. 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. NORTH BILLERICA, Mass. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. While the company generated $527M in revenue from Pylarify, revenue from its other radiopharmaceutical oncology products reached $4. 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. with suspected recurrence based on. In the U. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. 9% sodium chloride injection USP. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. ” Prostate cancer is a common and usually slow-growing 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. Under. to 6:00 p. 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. 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. The stock has been a big winner in 2022 thanks to the impressive growth racked up by recently launched imaging agent Pylarify. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. Melissa Downs. $ 68. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. S. 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. 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. On the call, management stated that PYLARIFY and DEFINITY enabled Lantheus to invest in its business to continue to. 01. Melissa Downs Senior Director, Corporate Communications 646. Lantheus Holdings, Inc. 37, while. S. • Assay the dose in a suitable dose calibrator prior to administration. ir@lantheus. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU 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. About Lantheus With more than 65 years of experience in delivering life. April 29, 2022 07:07 ET | Source: 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. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. 22, 2021 (GLOBE NEWSWIRE) -- 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. NORTH BILLERICA, Mass. PYLARIFY (piflufolastat F18) injection . February 10, 2022 17:33 ET | Source: Lantheus Holdings, Inc. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. 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. 0 million and $150. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Indication PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA). 45 and $0. Worldwide revenue of $102. Worldwide revenue of $239. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 2 million, compared with $129. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. NORTH BILLERICA, Mass.