1% and 119. 1 million in the prior year period; GAAP fully diluted net income per share of $1. Lantheus provides a broad. , [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. 6 million for the fourth quarter of 2021, representing an increase of 103. 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. 331 Treble Cove Road . (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. 01 µg/mCi of piflufolastat at calibration time and date, and ≤ 78. Their experience with these complex products and established footprint in commercializing PYLARIFY and AZEDRA makes them an ideal collaborator for these programs,” said Joe McCann, Ph. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 7 million in the same period last year. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. Q4 adjuested EPS grew +448% Y/Y to $1. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. 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. 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:. 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. Melissa Downs. com. 7 million for the third quarter 2023. Lantheus Holdings, Inc. m. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. 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. 7% year-over-year, and progressed our. 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. . U. 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. PYLARIFY, approved by the FDA in May 2021, is the first commercially and widely available prostate-specific membrane antigen (PSMA) PET imaging agent. Email: cspyl@lantheus. BEDFORD, Mass. 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. 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; TechneLite ® (Technetium Tc99m Generator), a technetium-based generator. Lantheus said its worldwide revenue for the period rose ~134% YoY to $239. is the parent company of Lantheus Medical Imaging, Inc. Assay the dose in a suitable dose calibrator prior to administration. S. S. to 6:00 p. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors. April 29, 2022 07:07 ET | Source: Lantheus Holdings, Inc. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. Lantheus Holdings, inc ( LNTH 2. Lantheus Holdings, Inc. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. This sample claim form is only an example. The FDA just recently approved the PSMA (piflfolastat F 18) scan. 331 Treble Cove Road . 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) ( 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. 9% Sodium Chloride Injection, USP. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. 4% from the prior year period. , Progenics Pharmaceuticals, 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:. PYLARIFY seems to be affected by the amount (level) of PSA in your blood. , Progenics Pharmaceuticals, Inc. The program is available to HCPs who have completed the PYLARIFY® Reader Training. Residents Only. 2 million, compared with $129. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. TechneLite net revenue was $24. Assay the dose in a suitable dose calibrator prior to administration. . 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. TechneLite net revenue was $24. 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 has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. CC-BY-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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 9% sodium chloride injection USP. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. BEDFORD, Mass. The results. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. It will need to spend additional. -1. 50 from the prior year period. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. S. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. “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. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . 15. Lantheus has been on a revenue growth spurt in recent quarters, boosted by 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. , June 12, 2023 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 50. Those with suspected metastasis who are candidates for initial definitive therapy or those with suspected recurrence based on elevated. In. NORTH BILLERICA, Mass. “In addition to FDA approval, inclusion in the guidelines. Lantheus Reports First Quarter 2023 Financial Results. NORTH BILLERICA,. [email protected] 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. 1-800-299-3431. 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. 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 Holdings, Inc. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. 1 million for the second quarter 2023, compared to GAAP net income of $43. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes. , a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). Follow the PYLARIFY® injection with an intravenous flush of 0. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. 3 million for the third quarter 2022, representing an increase of 134. Lastly, net cash used in operating activities was $32. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. U. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. 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. 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. Lantheus Holdings Inc. PYLARIFY was approved by the U. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. Worldwide revenue of $321. Lantheus Holdings, Inc. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lastly, net cash provided by operating activities was $116. 3% from the prior year period. 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. 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. This agent is similar to the Gallium-68 PSMA-11 agent which was approved in December 2020, except that it can be produced in much greater quantities and distrMarketBeat has tracked 5 news articles for Lantheus this week, compared to 5 articles on an average week. S. Eastern, Monday - Friday © 2023 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. com. "There are several, and there will be new ones down the. D. §287(a). m. ,. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. PYLARIFY may be diluted with 0. U. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. , CEO of POINT Biopharma. 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 . Strategic architect for the Uro-oncology franchise. $ 68. Lantheus Holdings, Inc. Customer Service: 1-800-299-3431: Hours: 7:30 a. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. S. NORTH BILLERICA, Mass. Eastern Time. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. Visit Investor Site. 97 for the first quarter of 2022, representing an increase of approximately $0. prostate cancer community and are likely to have contributed to the top. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. Lastly, net cash provided by operating activities was $116. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. All rights reserved. C. 66 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 agent. 1% over the. (LNTH) 1 Like. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. “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. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. Phone: 1-800-964-0446. Mark Kinarney. 99 for the third quarter of 2022, representing an increase of approximately $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. Developed by Lantheus, PYLARIFY ® was recently approved by the U. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Welcome to the Lantheus Third Quarter 2023 Financial Results. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. S. PYLARIFY may be diluted with 0. 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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus Holdings. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. S. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. Lantheus Holdings, Inc. m. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Melissa Downs Senior Director, Corporate Communications 646. But most. , a Lantheus company . It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. 2% for the week as of Friday afternoon,. INDICATION. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. , a Lantheus company. 5 million for the first quarter 2023. 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. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. 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. 3. Lantheus Original Approval date: May 26, 2021. Nov 2014 - Sep 2017 2 years 11 months. 6 million and $425. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. In the U. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, announced it will present the following presentations at. 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. NORTH BILLERICA, Mass. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. as the first U. 88 and earnings of $1. The company expects to. PYLARIFY Injection is designed to detect prostate-specific membrane. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. 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. 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. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. Lantheus Receives U. • Assay the dose in a suitable dose calibrator prior to administration. While the company generated $527M in. com. 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. PYLARIFY is a. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. June 12, 2023 at 8:30 AM EDT. 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. (RTTNews) - Lantheus Holdings Inc. “This. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@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. INDICATION. Lantheus Receives U. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. ir@lantheus. We executed on our strategy to accelerate growth, diversify our commercial and development portfolios, and position Lantheus as a category leader in the markets we serve. In June, Lantheus announced that it has demonstrated the higher efficiency and consistency of the Pylarify AI platform while maintaining the diagnostic accuracy of Prostate-Specific Membrane. PDF Version. S. In the U. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. It is the #1 PSMA PET Imaging. 2023 Annual Scan Potential Estimates 12. 18F-DCFPyL is now the first. Shares of Lantheus Holdings (LNTH-0. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. S. m. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. Lantheus Holdings, Inc. S. On-site plant will produce. Find out why LNTH stock is a Strong Buy. disease. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. 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. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 52%) were up 21. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. Progenics Pharmaceuticals, Inc. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. Jul. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. Pylarify accounted for $160. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, 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. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. and EXINI Diagnostics AB. Intended for U. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 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. The Company updates its guidance for the first quarter and full year 2023 is as follows: PYLARIFY revenues in 1H23 were $405m - up 82% year-on-year - so it seems clear that PYLARIFY revenues have substantially more growth potential - Lantheus' guidance for total revenues in 2023. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. by year endNORTH BILLERICA, Mass. S. We reported revenue of $319. Melissa Downs Senior Director, Corporate Communications 646. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. May 16, 2022 at 8:00 AM EDT. • Dispose of any unused PYLARIFY in compliance with applicable regulations. PYLARIFY® Peer-to-Peer Reader Assistance Program is a complementary program to the PYLARIFY® Reader Training that provides guidance and assistance to healthcare providers on how to accurately read and interpret PYLARIFY® scans. com. (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. 9% Sodium Chloride Injection, USP. 86 for the third quarter 2022, compared to. 7 million for the second quarter 2022, representing an increase of 121. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. -1. PYLARIFY may be diluted with 0. 9 mg ethanol in 0. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. Our products have practical applications in oncology, cardiology and more. 4% from the prior year period; GAAP net income of $43. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the. , [18F]-DCFPyL was approved by the FDA in May of 2021 and is commercially available as PYLARIFY® (Piflufolastat F 18 Injection) and sold by Lantheus. , Nov. • Visually inspect the radiopharmaceutical solution. ” 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 agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. S. BEDFORD, Mass. Lantheus Receives U. 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. Lantheus provides a broad portfolio of products, including PYLARIFY. 24%) Q2 2021 Earnings Call. In patients with. With 3 million men living with prostate cancer and more than 18. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. Worldwide revenue of $129. 4. 3% over the prior year. 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 Reports Second Quarter 2023 Financial Results. The following U. LNTH earnings call for the period ending June 30, 2021. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. S. Lantheus Medical Imaging has received approval from the U. Purpose of this notice. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. PDF Version. 2% for the week as of Friday afternoon,. 9% sodium chloride injection USP. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. , Nov. 5 million, representing 61. 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”). , Nov. com. Lantheus Receives U. 6 million worth of sales while DEFINITY contributed $63. • Calculate the necessary volume to administer based on calibration time and required dose. 0. 47, as compared to $0. November 3, 2022 at 7:00 AM · 11 min read. 4 million in revenue, up 25% year over year, and a net loss of $11. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. 97 for the first quarter of 2022, representing an increase of approximately $0. price-eps-surprise | Lantheus Holdings, Inc. com. Pylarify. Jul 28, 2021, 8:00 a. 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. S. LNTH is expected to report second-quarter 2022 results on Jul 27. Follow. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 646-975-2533. 45 and $0. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. 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. NEW YORK, Jan. 5 million for the first quarter 2023. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. 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. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. PYLARIFY (piflufolastat F18) injection. 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. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. Lantheus Holdings, Inc. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. com. 9 million for the first quarter 2022, representing an increase of 125. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). 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. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. The merger agreement was first announced on October 2, 2019 . 0. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. PYLARIFY PSMA - Where and when. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra.