Lantheus credited the revenue rise from increased sales for its Pylarify PSMA PET imaging agent, used to detect recurrent or metastatic prostate cancer, as well as increased use of its Definity. 28, 2021 2:48 PM ET Lantheus Holdings, Inc. 45%. 36%) Q3 2021 Earnings Call. , a Lantheus company. reference drug program proton pump inhibitors (ppis) section 3 – diagnosis for requested medication gastroesophageal reflux disease (gerd), or reflux esophagitis, or duodenal. by year endNORTH BILLERICA, Mass. , Progenics Pharmaceuticals, Inc. This indicates a strong confidence in Pylarify’s growth, even amidst new. 3M as the prostate cancer diagnostic agent Pylarify added $143. 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. 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. 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. 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. 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. ” Prostate cancer is a common and usually slow-growing cancer. 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. 3 million, compared with $102. Además del éxito de PYLARIFY, Lantheus también destacó oportunidades de crecimiento en el tratamiento del cáncer de próstata con su producto PNT2002. Purpose of this notice. 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. “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. PYLARIFY Injection is designed to detect prostate-specific membrane. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. Lantheus Reports Second Quarter 2023 Financial Results. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. with suspected recurrence based on. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 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. S. 1 million for the third quarter of 2021, representing an increase of 134. 37. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. 6 million worth of sales while DEFINITY contributed $63. 4% from the prior year period ; GAAP net income of $61. PET/CT. 3% over the prior. and EXINI Diagnostics AB. Lantheus Receives U. com. Eastern, Monday - Friday © 2023 Lantheus. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. 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. -1. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging. S. Lantheus Receives U. 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. 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. This was another terrific quarter for Lantheus. (LNTH) 1 Like. Follow the PYLARIFY® injection with an intravenous flush of 0. But most. 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. Today, we put the spotlight on Lantheus Holdings for the first time. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 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. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. 0% from the prior year period. Lantheus Holdings, Inc. prostate cancer community and are likely to have contributed to the top. disease. BEDFORD, Mass. , Nov. In 2023, PYLARIFY, the #1 PSMA PET imaging agent and DEFINITY, the #1 ultrasound enhancing agent, will continue to deliver value for our patients, healthcare professionals, employees, and shareholders. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. Food and Drug Administration (FDA) has approved. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. On the fourth-quarter 2022 earnings call in February, Lantheus Holdings’ management confirmed that it has been registering a robust uptick in sales of its PYLARIFY, an F 18-labelled PSMA. May 16, 2022 at 8:00 AM EDT. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. 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. 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. com. 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. 7 million for the second quarter 2023, representing an increase of 43. S. Since then, Lantheus' sales have more than doubled. , Nov. The FDA just recently approved the PSMA (piflfolastat F 18) scan. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. 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. , Professor of Urology, University of California San DiegoLantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. com. 61 for the second quarter. 5 million, representing 61. 2% from the prior year quarter due to. The. S. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancer. Minimum 15 minutes delayed. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. In the U. But. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. US Customer Service/Order PYLARIFY®. • Assay the dose in a suitable dose calibrator prior to administration. Third quarter operating cash. 50 from the prior year period. 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. "There are several, and there will be new ones down the. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. S. is the parent company of Lantheus Medical Imaging, Inc. , Progenics Pharmaceuticals, Inc. Lantheus Holdings, Inc. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. 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. 4% from the prior year period. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. Worldwide revenue of $239. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. , a Lantheus company. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. The results. INDICATION. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. 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. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. 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. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. 61 per fully diluted share, as compared to GAAP net loss. OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 men with either high-risk prostate cancer (Cohort A; n=268) or radiologic evidence of recurrence (Cohort B; n=117) OSPREY assessed the sensitivity, specificity, PPV, and NPV in pelvic lymph nodes for PYLARIFY® PET/CT. February 16, 2023 at 8:30 AM EST. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. With 3 million men living with prostate cancer and more than 18. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. , May 23, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. BEDFORD, Mass. Phone: 1-800-964-0446. 9% over the prior year periods. 7 million for the third quarter 2023. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. Published online May 11, 2022. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 86 per fully diluted share, as compared to GAAP net loss of. While the company generated $527M in. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. 9% sodium chloride injection USP. (RTTNews) - 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. ET. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. In the last reported quarter, Lantheus earnings per share (EPS) of $1. “Being selected by Lantheus to partner to administer the first dose of PYLARIFY is an honor, and it’s humbling to know that GenesisCare will be potentially helping men with prostate cancer, while improving access to high-quality care for our patients. In. In the U. Worldwide revenue of $300. NORTH BILLERICA, Mass. Compelling Rationale for Lantheus Leverages Lantheus’ radiopharmaceutical leadership in prostate cancer (PYLARIFY) and neuroendocrine tumors (AZEDRA) Solidifies potential to drive long-term, sustainable and diversified revenue, earnings and free cash flow growth Milestone-based structure maintains Lantheus’. Image source: The Motley Fool. 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”). (NASDAQ:LNTH) Q3 2023 Earnings Call Transcript November 3, 2023 Operator: Good morning. Contact information For media. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). Lantheus has been on a revenue growth spurt in recent quarters, boosted by Pylarify. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. , a Lantheus company. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. S. Jul 28, 2021, 8:00 a. 6 million and $425. 2% for the week as of Friday afternoon,. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. S. 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. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 4% from the prior year period. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). CC-BY-4. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. Jul 21, 2022 02:13PM EDT. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. 3. 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. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. m. 5 million, representing 61. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. 4. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. 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. Lantheus' Key Products Driving Growth. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. , Nov. The Company’s second quarter 2022 GAAP net income was $43. 8% from the prior year period. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. 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. Read more about Lantheus Announces Top Rated Oral Presentation. An FDA-cleared medical device software, PYLARIFY AI V1. com. Lantheus Holdings, which belongs to the Zacks Medical - Products industry, posted revenues of $300. 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. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). About Lantheus With more than 65 years of experience in delivering life. 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 hindsight it appears that the sellside failed to appreciate Pylarify's potential. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. 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. 3 million for the third quarter 2022, representing an increase of 134. "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. 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 PYLARIFY. “In addition to FDA approval, inclusion in the guidelines. (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. CAS Number: 1423758-00-2. PYLARIFY AI™ is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. Lantheus Holdings, Inc. PYLARIFY PSMA - Where and when. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. The Lantheus Protocol: Pylarify Growth May Slow The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. The Company 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. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. These developments underscore Lantheus’ efforts to establish PYLARIFY as a PSMA PET imaging agent of choice in the U. NORTH BILLERICA,. DULLES, Va. (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. 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 may be diluted with 0. The company also received a CE marking in Europe for PYLARIFY AI. 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. 7% year-over-year, and progressed our. m. 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. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. . The device provides general. 3 million for the third quarter 2022, representing an increase of 134. In the U. Fax: 978-436-7296. S. S. , [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. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. For the full year 2022, Lantheus forecasts PYLARIFY to be in a range of $300M to $325M and their. Lantheus Receives U. (NASDAQ:NASDAQ:LNTH) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ETCompany ParticipantsMary Anne Heino – President and Chief Executive Officer Mark. 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. 50. 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. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. 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. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. 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. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. TechneLite net revenue was $24. “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 following U. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. , Nov. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. , Nov. 96 and $0. In the U. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. 7 million in the prior year period ; GAAP fully diluted net income per share of $0. United States of America . 2% from the prior year quarter due to. Heino , President and Chief Executive Officer of Lantheus . INDICATION. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the. 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. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. The merger agreement was first announced on October 2, 2019 . and EXINI Diagnostics AB. The stock has been a big winner in 2022 thanks to the impressive growth racked up by recently launched imaging agent 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. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. Leadership provided initial guidance for FY2023 as well. Lantheus Receives U. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. 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. U. PYLARIFY® IS UNIQUE. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. with suspected recurrence based on. 1 million for the third quarter 2021, representing an increase of 15. 0. 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 AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. David Crawford, M. Lastly, net cash provided by operating activities was $116. ,. 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. Worldwide revenue of $263. 4% from the prior year period. GAAP. This page is intended to serve as notice under 35 U. Melissa Downs Senior Director, Corporate Communications 646. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. 9% Sodium Chloride Injection, USP. 1 million in the prior year period; GAAP fully diluted net income per share of $1. In the U. UAB Therapy Intensive Program – for Technologists. Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis. 7 million for the second quarter 2022, representing an increase of 121. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. (“the Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. The company believes the approval of a PSMA-targeted therapeutic for the treatment of adult patients with PSMA-positive metastatic castration. , Sept. D. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. 8 million for the first quarter 2023, representing an increase of 44. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. 52%) were up 21. 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. 50 from the prior year period. NORTH BILLERICA, Mass. May 4, 2023 at 7:00 AM · 10 min read. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. For $260m Lantheus secured rights to Point’s two most advanced radioligand therapeutic projects, one of which concerns prostate cancer and hits PSMA – the target for Pylarify and for two Lantheus development-stage therapeutics. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. , VP, Medical Affairs E. Melissa Downs Senior Director, Corporate Communications 646. 9% Sodium Chloride Injection USP. 6% and an increase of 25. S. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. Lantheus Holdings, inc ( LNTH 2. “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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Melissa Downs Senior Director, Corporate Communications 646-975-2533 media@lantheus. as the first U. (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. 37. Greater Chicago Area. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. S. • Dispose of any unused PYLARIFY in compliance with applicable regulations. and EXINI Diagnostics AB. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. 0% from the prior year period.