Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. 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. In the U. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. 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:. Lantheus Holdings, Inc. DEFINITY in our in-house manufacturing facility; (v) our ability to successfully launch PYLARIFY AI as a commercial product; (vi) the continuing impact of the global COVID-19 pandemic on our business, supplyPhysicians and staff can use this resource to streamline access and reimbursement for PYLARIFY® (piflufolastat F 18) injection for appropriate patients. 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. 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. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. Product Uses . 2021 was a year of significant achievements for Lantheus. Lantheus Holdings, Inc. 1 million for the second quarter 2022, compared to GAAP net loss of $26. 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. 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. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. S. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. Leadership provided initial guidance for FY2023 as well. GAAP net loss. 36%) Q3 2021 Earnings Call. Minimum 15 minutes delayed. The company'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. 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. 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. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. 15. In the U. 54. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. NORTH BILLERICA, Mass. 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. Under a commercial supply agreement with Lantheus, SOFIE will roll out PYLARIFY via its national network, which has manufactured numerous PYLARIFY doses for Lantheus during the clinical trials. Develop and deploy marketing strategies to drive ROI, sales and margin. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Billerica, MA 01862 . Now turning to cash flow. S. S. S. Pylarify. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 4% from the prior year period ; GAAP net income of $61. 1. In the U. Contact information For media. 8 billion tied up in biobucks. 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. 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. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. Developed by Lantheus, PYLARIFY ® was recently approved by the U. 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. U. The collaboration with Novartis directly aligns with Lantheus’ strategy to advance cancer precision medicine by enabling partners to use PYLARIFY in prostate cancer therapeutic. 97 for the first 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. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. 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. NORTH BILLERICA, Mass. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. INDICATION. 2 million for the third quarter 2022, compared to GAAP net loss of $13. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. S. On-site plant will produce. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. , [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 Holdings, Inc. 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. 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 . We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform. The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. Director, Corporate Communications. Worldwide revenue of $208. NORTH BILLERICA, Mass. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. 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. Syntermed announces its appointment by Lantheus Holdings, Inc. 8 million for the first quarter 2023, representing an increase of 44. S. [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. This other product, even though it was, I'll say, riding the wave of the momentum that. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 45%. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. . 8 million for the first quarter 2023, representing an increase of 44. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. 8 million, compared to a loss of $21. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. --(BUSINESS WIRE)--May 27, 2021-- Lantheus Holdings, Inc. 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. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud to. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. • Visually inspect the radiopharmaceutical solution. S. Lantheus Holdings, Inc. 7% year-over-year, and progressed our. Lantheus Announces Presentation Featuring PYLARIFY® (Piflufolastat F18) at the 2022 ASCO GU Meeting. In the U. Email: cspyl@lantheus. . Lantheus Receives U. In the U. INDICATION. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. (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. 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. The FDA approved the F 18-labeled prostate-specific membrane antigen (PSMA)–targeted positron emission tomography (PET) imaging agent 18F-DCFPyL (Pylarify) for use in prostate cancer, according to an announcement from the company responsible for the agent, Lantheus Holdings, Inc. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. About Lantheus With more than 65 years of experience in delivering life. , a Lantheus company 331. Progenics Pharmaceuticals, Inc. 3. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. 2 million and $935. TechneLite net revenue was $24. Accelerates European Development of PSMA-Targeted Imaging Agent with Global Leader in Nuclear Medicine. ” Read more about PyL here and about the amazing science behind PSMA hereLantheus Holdings, Inc. BEDFORD, Mass. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. 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. 89 for the second quarter of 2022, representing an increase of approximately $0. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. Lantheus Holdings, Inc. Lantheus Receives U. 1 million for the second quarter 2023, compared to GAAP net income of $43. S. • Calculate the necessary volume to administer based on calibration time and required dose. (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. CC-BY-4. , a Lantheus company . S. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to. 8% from the prior year period. , [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. PYLARIFY® [package insert]. 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. 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. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. (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. Nov 6, 2021, 2:00 p. 66 from the prior year period. News release. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. (NASDAQ:NASDAQ:LNTH) Q3 2022 Earnings Conference Call November 3, 2022 8:00 AM ETCompany ParticipantsMark Kinarney - VP, IRMary. “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. 45 and $0. GAAP net. price-eps-surprise | Lantheus Holdings, Inc. 1 million for the fourth quarter and full year 2022, representing increases of 103. • Assay the dose in a suitable dose calibrator prior to administration. Worldwide revenue of $239. Lantheus experienced tremendous growth in last 2 years thanks to the approval of a new imaging agent called PYLARIFY. 9% Sodium Chloride Injection USP. CAS Number: 1423758-00-2. “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. The company reports earnings on November 3, with analysts expecting the company to top last year's results. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. S. Shares of Lantheus Holdings (LNTH-0. Coordination of care. Lantheus Holdings, Inc ( LNTH 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. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. ” Prostate cancer is a common and usually slow-growing cancer. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. Heino , President and Chief Executive Officer of Lantheus . S. PYLARIFY (piflufolastat F18) injection. US Customer Service/Order PYLARIFY®. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. prostate cancer community and are likely to have contributed to the top. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. Visit Investor Site. For men with prostate cancer,. 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. (LNTH) 1 Like. 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 Reports First Quarter 2023 Financial Results. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. 6 million worth of sales while DEFINITY contributed $63. , [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. Third quarter operating cash. In May 2021, Lantheus won Food and Drug Administration approval for its newest growth driver, Pylarify. 28 May, 2021, 07:00 ET. 54, as compared to $0. Based in North Billerica, Mass. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. The creation of artificial high-performance photosynthetic assemblies with a tailorable antenna system to deliver absorbed solar energy to a photosynthetic reaction center,. 0% from the prior year period. 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 may be diluted with 0. 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. 78 million for the quarter ended March 2023, surpassing the Zacks Consensus Estimate by 7. Lantheus is paying $260 million upfront for a double bill of licenses for two of POINT Biopharma’s radiopharmaceutical oncology candidates, with another $1. Jul 28, 2021, 8:00 a. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. , CEO of POINT Biopharma. and Progenics Pharmaceuticals, Inc. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. 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. , [18 F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. Worldwide revenue of $129. 7 million for the second quarter 2022, representing an increase of 121. 12. 3. For men with prostate cancer, PYLARIFY. is the parent company of Lantheus Medical Imaging, Inc. 37, surpassing the consensus of $0. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. GAAP fully diluted earnings per share were $1. Pylarify PET detected at least one positive lesion in at least one body region (bone, prostate bed, pelvic lymph node, other lymph nodes, or soft tissue) in 60% of these patients. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. 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. An FDA-cleared medical device software, PYLARIFY AI V1. GAAP net. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. This means that a negative PYLARIFY PET/CT scan does not rule out that you have prostate cancer, and a positive PYLARIFY PET/CT scan does not confirm that you have prostate cancer. 9, 2020-- Lantheus Holdings, Inc. 9% Sodium Chloride Injection, USP. 4. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). 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. 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. 7 million is being distributed to the holders. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. , Progenics Pharmaceuticals, Inc. S. PYLARIFY was approved by the U. 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. S. 1% and 119. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. PYLARIFY AI™ (aPROMISE) is the only deep learning enabled FDA-cleared medical device software to offer standardized PSMA PET reporting with PYLARIFY AI on PSMA PET/CT images, including those. (the “Company”) (NASDAQ: LNTH), an established leader and fully. 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. m. Pylarify is the largest growth driver for the company as it comprised 65% of. Worldwide revenue of $321. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. LNTH is expected to report second-quarter 2022 results on Jul 27. For International Transportation Emergencies Call CC-BY-4. But. 9% Sodium Chloride Injection USP. (“Lantheus”) (NASDAQ: LNTH), a company committed to improving. 01. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. PET/CT. Lantheus Receives U. Image source: The Motley Fool. , Nov. BEDFORD, Mass. 61 for the second quarter. For the full year 2022, Lantheus forecasts PYLARIFY to be in a range of $300M to $325M and their. Lantheus expects their fully diluted adjusted earnings per share to be between $0. 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. 0 is commercially available in the United States . Lantheus Receives U. INDICATION. NORTH BILLERICA,. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. 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. PRODUCT NAME: PYLARIFY (piflufolastat F18) injection CAS Number: 1423758-00-2 Product Uses: diagnostic radiopharmaceutical COMPANY. Purpose of this notice. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 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. Phone: 800-343-7851 Press Option 2 for Adverse Events and/or for Product Quality Complaints. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. 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 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. PYLARIFY may be diluted with 0. March 29, 2022 at 8:00 AM · 8 min read. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. $ 68. 9 million for the first quarter 2022, representing an increase of 125. NORTH BILLERICA, Mass. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. S. The Company’s worldwide revenue for the third quarter of 2022 totaled $239. ET. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, 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. 9% Sodium Chloride Injection, USP. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. com. 2 million for the fourth quarter and full year 2021, representing an increase of 37. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. PDF Version. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. Lantheus Holdings. 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. Quote. PYLARIFY (piflufolastat F18) injection. Lantheus Holdings, Inc. (“Progenics”), a Lantheus company, does not recommend or endorse any site included in the PYLARIFY® Imaging Site Locator for any purpose. 3 million, compared with $102. 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. Lantheus’ product, PYLARIFY, is a radioactive diagnostic agent indicated for PET imaging of PSMA positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and/or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. 1 million for the second quarter of 2021, representing an increase of 121. 646-975-2533. 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. S. NORTH BILLERICA,. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. Phone: 1-800-964-0446. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. February 16, 2023 at 8:30 AM EST. Sanchez-Crespo A. Frederic Pouliot, Hospitalier Universitaire (CHU) de Québec-Université Laval. 3. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. 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. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. BEDFORD, Mass. The Lantheus Protocol: Pylarify Growth May Slow. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. This sample claim form is only an example. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Product Uses: diagnostic radiopharmaceutical . 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. Follow the PYLARIFY® injection with an intravenous flush of 0. S. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. , Nov.