US Customer Service/Order 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. ET. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. NORTH BILLERICA, Mass. “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. 6% and an increase of 25. The company reported Q4 adjusted EPS of $1. The Company’s first quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. NORTH BILLERICA, Mass. But most. The. The stock has been outperforming its index, the S&P Midcap 400, by a wide margin. Worldwide revenue of $300. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States . 9% over the prior year periods. S. Lantheus Receives U. Lantheus says its technology can help improve the management of prostate cancer patients. S. 61 per fully diluted share, as compared to GAAP net loss. North Billerica, MA: Progenics Pharmaceuticals, Inc. S. EMERGENCY PHONE: CHEMTREC 1-800-424-9300. --(BUSINESS WIRE)--May 27, 2021-- Lantheus Holdings, Inc. Mark Kinarney. NORTH BILLERICA,. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. “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 seems to be affected by the amount (level) of PSA in your blood. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. (LNTH) 1 Like. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. BEDFORD, Mass. Lantheus Holdings, Inc ( LNTH 0. 1-800-299-3431. 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. S. 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. Read More. 0. PYLARIFY (piflufolastat F18) injection . Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023. 3M as the prostate cancer diagnostic agent Pylarify added $143. Follow. [Image courtesy of Lantheus] Lantheus is a developer of AI-powered diagnostic and therapeutic products. 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. 5 million for the first quarter 2023. • Visually inspect the radiopharmaceutical solution. PYLARIFY® may help detect metastases even when PSA levels are low. Worldwide revenue of $239. 18F-DCFPyL is now the first. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for. Progenics Pharmaceuticals, Inc. Post Administration Instructions • Follow the PYLARIFY injection with an intravenous flush of 0. U. is the parent company of Lantheus Medical Imaging, Inc. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. The Company’s worldwide revenue for the second quarter of 2022 totaled $223. 86 for the third quarter 2022, compared to. Lantheus Holdings, Inc. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. Lantheus Holdings, Inc. Lantheus provides a broad. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. Greater Chicago Area. His confidence is backed by Lantheus’s Q3 results which exceeded Street expectations, largely due to the continued strength of their product, Pylarify, and their Precision Diagnostics segment. S. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. Pylarify is an injectable agent that helps highlight prostate cancer under a PET scan. Lantheus Receives U. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men. --(BUSINESS WIRE)--Dec. June 12, 2023 at 8:30 AM EDT. LinkedIn. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. Pylarify accounted for $160. But most. BEDFORD, Mass. 4. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. by year endNORTH BILLERICA, Mass. As a leader in the development, manufacture and commercialization of pioneering diagnostic and therapeutic products, we’re determined to Find, Fight and Follow ® a broad range of diseases. 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, Inc. A sample CMS-1500 claim form for billing PYLARIFY® is provided below. istering 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. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. m. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. , a Lantheus company . 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. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. Lantheus Holdings, Inc. 4 million in revenue, up 25% year over year, and a net loss of $11. NASDAQ | LNTH (Common Stock) Data provided by Nasdaq. 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. For more information, visit Contacts: Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus. 3% over the prior year. 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. 8 billion tied up in biobucks. 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 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. 9 million for the first quarter 2022, representing an increase of 125. News release. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative. Lantheus Holdings, Inc. with suspected recurrence based on. 3 million for the third quarter 2022, representing an increase of 134. Lantheus Reports Second Quarter 2023 Financial Results. In the last reported quarter, Lantheus earnings per share (EPS) of $1. The Company’s worldwide revenue for the fourth quarter of 2022 totaled $263. As a result of the net sales generated by PYLARIFY in 2022, the maximum aggregate cash payment of $99. 1% and 119. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. 1M in 2022, following a 25% YoY decline, according to the. BEDFORD, Mass. 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. , Sept. CAS Number: 1423758-00-2. , June 12, 2023 (GLOBE NEWSWIRE) -- 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. Search Interest 21 people have searched for LNTH on MarketBeat in the last 30 days. 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. 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. 1% over the. Based in North Billerica, Mass. Outside U. The program is available to HCPs who have completed the PYLARIFY® Reader Training. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. S. S. 4. 2% for the week as of Friday afternoon,. “PYLARIFY AI is the first and only FDA-cleared medical device software that offers a standardized platform for quantifying PSMA PET/CT images,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. 66 from the prior year period. Lantheus receives US FDA approval of PYLARIFY (piflufolistat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. 17%. Worldwide revenue of $300. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40% of U. m. 7 million for the third quarter 2023. . Nov 6, 2021, 2:00 p. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative imaging diagnostics. 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. The program is available to HCPs who have completed the PYLARIFY® Reader Training. The results. Attend the UAB Nuclear Medicine and Molecular Therapy Intensive, offered in collaboration with SNMMI-TS, Monday, April 29. NORTH BILLERICA, Mass. In the U. 50. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. and EXINI Diagnostics AB. NORTH BILLERICA, Mass. S. S. PYLARIFY Injection is designed to detect prostate-specific membrane. Director, Corporate Communications. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer May 27, 2021 PYLARIFY will be available immediately to imaging centers in parts of the mid- Atlantic and southern regions and is expected to be broadly availableEven if Bracco were to secure 40%+ share in an expanding F-18 PSMA PET imaging market over the next 3 years, the Truist team still thinks Pylarify and Lantheus are undervalued, especially with the. Pylarify is labeled with F-18 and homes in on PSMA, a protein that is overexpressed on the surface of more than 90% of. 1% over the. 25 reported a year ago. 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. ir@lantheus. 978-671-8842. 31 Mar, 2022, 09:00 ET. , Nov. The Company’s second quarter 2022 GAAP net income was $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. The stock has been a big winner in 2022 thanks to the impressive growth racked up by recently launched imaging agent Pylarify. Read more about Lantheus Announces Top Rated Oral Presentation. is the parent company of Lantheus Medical Imaging, Inc. 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. 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. (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 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 success leads to maximum payment in first yearBEDFORD, Mass. Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc. ” Prostate cancer is a common and usually slow-growing cancer. In the U. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. Develop and deploy marketing strategies to drive ROI, sales and margin. (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. diagnostic radiopharmaceutical. 33 for the second quarter 2023, compared. 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 8% from the prior year period; GAAP net income of $94. Lantheus Holdings, Inc. , Nov. 3 million for the third quarter 2022, representing an increase of 134. NORTH BILLERICA, Mass. Third quarter operating cash. 4% from the prior year period; GAAP net income of $43. com. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . 2% for the week as of Friday afternoon,. , Lantheus received approval for [18 F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. Follow the PYLARIFY® injection with an intravenous flush of 0. S. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Pylarify is the largest growth driver for the company as it comprised 65% of. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. 7 million is being distributed to the holders. Minimum 15 minutes delayed. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. The Company’s second quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. U. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 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. Lantheus Receives U. Published online May 11, 2022. 7 million, up 12. , Nov. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. 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. 0. “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. Lastly, net cash provided by operating activities was $108. Now, with 2 PSMA PET radiotracers approved, this type of imaging will become more widely available for 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. 4 million in the prior year period ; GAAP fully diluted net income per share of $0. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). Find out why LNTH stock is a Strong Buy. The. We are conducting a phase 2 trial of LNTH-1095 in mCRPC pre. Quote. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. NEW YORK, Jan. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. 4% 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. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. Lantheus Holdings (LNTH) announced Thursday that it would discontinue production and promotion of its FDA-approved radiotherapeutic Azedra. All rights reserved. Product Uses . diagnostic radiopharmaceutical. S. This page is intended to serve as notice under 35 U. C. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. PYLARIFY® [package insert]. Accessed May 11, 2022. • Dispose of any unused PYLARIFY in compliance with applicable regulations. Customer Service: 1-800-299-3431: Hours: 7:30 a. Lantheus Holdings, inc ( LNTH 2. TechneLite net revenue was $24. Lantheus Medical Imaging has received approval from the U. BEDFORD, Mass. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET. “The transaction leverages Lantheus’. Worldwide revenue of $239. 331 Treble Cove Road . 5 million for the first quarter 2023. – Paul Blanchfield, Chief Commercial Officer at Lantheus. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite ® (Technetium Tc99m Generator), a. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. In the U. 331 Treble Cove Road . 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. Eastern Time. Pylarify. Lastly, net cash used in operating activities was $32. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. 3. com. Lantheus Presents Results from a PYLARIFY AI™ Study at the American Urological Association (AUA) Annual Meeting. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. Novartis will include PYLARIFY® (piflufolastat F18) in their clinical trials for Pluvicto™ (lutetium Lu. , a Lantheus company. Lantheus has Pylarify, a Flourine-18 isotope radioimaging product that selects patients for PSMA-targeted RLT. ET. Lantheus market research and analysis with ordering physicians, NCCN, ACS, UpToDate, SEER. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. 03, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, 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; TechneLite ® (Technetium Tc99m Generator), a. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in. “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. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. com. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. U. Worldwide revenue of $321. S. (the “Company”) (NASDAQ: LNTH), an established leader and fully. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. 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. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. The company's. with suspected recurrence based on. 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. Follow the PYLARIFY® injection with an intravenous flush of 0. Q4 adjuested EPS grew +448% Y/Y to $1. (RTTNews) - Lantheus Holdings Inc. m. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. The company also received a CE marking in Europe for PYLARIFY AI. (the Company) (NASDAQ: LNTH), a company committed to improving patient outcomes. 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. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. November 3, 2022 at 7:00 AM · 11 min read. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. PYLARIFY may be diluted with 0. PYLARIFY (piflufolastat F18) injection. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lantheus spent months preparing for PYLARIFY's launch and has scaled up the company's commercial, medical, and manufacturing capabilities to ensure the launch is successful. Mid-cap Lantheus Holdings has been on a revenue growth spurt boosted by a new product called Pylarify, which helps detect prostate cancer in an imaging test. 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. 6 million and $425. 6 million to the ante. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. patents apply to our products: DEFINITY ® /DEFINITY. PYLARIFY AI is an FDA-cleared medical device software and is commercially available in the United States. 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. Intended for U. D. 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. D. PYLARIFY is a. “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. Lantheus Receives U. 9% Sodium Chloride Injection USP. 8% from the prior year period. 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. 15. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. 4% from the prior year period. March 29, 2022 at 8:00 AM · 8 min read. Under. But most. , a Lantheus company. , VP, Medical Affairs E. 97 for the first quarter of 2022, representing an increase of approximately $0. 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. S. 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. We accelerated our growth. 9% Sodium Chloride Injection, USP. 86 per fully diluted share, as compared to GAAP net loss of. 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. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer NORTH BILLERICA, Mass. Worldwide revenue of $129. 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. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced today that the U. It will need to spend additional. 01. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer,. 5 stocks we like better than LantheusNano-X reported $2. Melissa Downs Senior Director, Corporate Communications 646-975-2533 media@lantheus. Sanchez-Crespo A. D. 47, as compared to $0. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. as the first U. This was another terrific quarter for Lantheus. In May 2021, the FDA approved the PSMA PET imaging agent piflufolastat F 18 (Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. -1. 01 μg/mCi of piflufolastat at calibration time and date, and ≤ 78. The Pylarify AI system is a deep learning algorithm that allows physicians to. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and.