For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. Worldwide revenue of $102. , a Lantheus company. Jul. 37, while. 9% over the prior year periods. MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. Product Uses . S. 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. 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. 1% over the. 50 from the prior year period. Worldwide revenue of $300. Nov 6, 2021, 2:00 p. We accelerated our growth. PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer. For information about locations offering this type of scan, ask your doctor or contact customer service at Lantheus, the manufacturer of PYLARIFY. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. 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 it will present the following presentations at. 5 million, representing 61. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. Purpose of this notice. 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. com. 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. Jul 21, 2022 02:13PM EDT. PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. Comparison of Gallium-68 and Fluorine-18 imaging characteristics in positron emission. Apart from PYLARIFY’s impressive performance, Lantheus Holdings boasts a robust product portfolio with the potential for double-digit growth. BEDFORD, Mass. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. The program is available to HCPs who have completed the PYLARIFY® Reader Training. 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. UPDATE: On March 23, 2022, the Food and Drug Administration (FDA) approved Lu177-PSMA-617 (Pluvicto) to treat some adults with metastatic prostate cancer. PYLARIFY may be diluted with 0. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancerNORTH BILLERICA, Mass. It followed that with Pylarify in June 2021, an injectable agent that helps doctors identify prostate cancer using a PET scan. Q4 adjuested EPS grew +448% Y/Y to $1. 54. By Kate Stalter • Oct 28, 2022LNTH earnings call for the period ending September 30, 2021. D. 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. com. S. GAAP. Retrospective analysis demonstrates reliability of PSMA scan indices as response-imaging biomarker to androgen therapy in prostate cancer. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. is the parent company of Lantheus Medical Imaging, Inc. Lantheus Holdings, Inc. 3% over the prior year. Phone: 978-667-9531 Press Option 2 for Adverse Events and/or for Product Quality. (“the Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence. Melissa Downs. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm ET, or email [email protected] Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. com. PRODUCT NAME: PYLARIFY (piflufolastat F18) injection CAS Number: 1423758-00-2 Product Uses: diagnostic radiopharmaceutical COMPANY. Lantheus Holdings, inc ( LNTH 2. 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”). 7 million for the third quarter 2023. S. NORTH BILLERICA, Mass. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions. 01, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings , Inc. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. • Calculate the necessary volume to administer based on calibration time and required dose. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. 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. c/o Lantheus Holdings 331 Treble Cove Road Billerica, MA 01862 United States of America 1-800-299-3431 . 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), an established leader and fully integrated provider committed to innovative. SOFIE’s Vice President of Sales & Marketing, Mike Parisi, states, “We are thrilled to partner with Lantheus to commercially supply this new and. 17%. 2 million, or $0. 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. Hours: 8:30 am to 8:00 pm ET, Monday to Friday. #Lantheus was thrilled to be a Gold Sponsor of the 16th Clinical Trials on Alzheimer’s Disease conference (CTAD), which took place from Oct 24-27 in Boston! It was a wonderful opportunity to connect with our partners in the industry and academia who are using our investigational Tau PET imaging agent in their clinical trials. Lantheus experienced tremendous growth in last 2 years thanks to the approval of a new imaging agent called PYLARIFY. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. Lantheus to Host Third Quarter 2023 Earnings Conference Call and Webcast on November 2, 2023, at 8:00 a. NORTH BILLERICA,. S. 52%) were up 21. November 29, 2021 08:30 ET | Source: Lantheus Holdings, Inc. INDICATION. and EXINI Diagnostics AB. 23, 2023 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for ENVX, GSM, AMC, LAZR, and LNTH. Leading the way for Lantheus is PYLARIFY, which delivered sales of $210. m. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. The problem for Point, a group that went public amid much fanfare as a Spac last year, is that investors had been. 66 from the prior year period. ATLANTA, March 31, 2022 /PRNewswire-PRWeb/ -- Syntermed is proud to. 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. Find out why LNTH stock is a Strong Buy. Follow the PYLARIFY® injection with an intravenous flush of 0. 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. 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. , a Lantheus company. Diagnostic performance of 18 F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. "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. 48 from the prior year period. Customer Support at 1-800-964-0446 M-F 8:30 am-8:00 pm EST, or email cspyl@lantheus. 96 and $0. June 12, 2023 08:30 ET | Source: Lantheus Holdings. Melissa Downs Senior Director, Corporate Communications 646. Indication PYLARIFY ® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen. We reported revenue of $319. 45%. S. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear. It is worth mentioning that PYLARIFY is an F 18-labelled PSMA-targeted. The Company’s third quarter 2023 adjusted fully diluted net income per share, or earnings per share (“EPS”), was $1. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino, President. GAAP net. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging. News release. NORTH BILLERICA, Mass. 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. According to Evaluate, doctors prescribing Pluvicto are abandoning Novartis' own. 8% from the prior year period; GAAP net income of $94. 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’. June 12,. Lantheus Holdings’ Pylarify injection is a fluorinated small molecule PSMA-targeted PET imaging agent that allows for the visualization of lymph nodes, bone and soft tissue. 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 . 0 million and $150. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. Lastly, net cash provided by operating activities was $116. 47 on an adjusted basis, an increase of 48% over the prior-year quarter. Lantheus Holdings. 4. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY®, a PSMA PET imaging agent. May 16, 2022 at 8:00 AM EDT. About Lantheus With more than 65 years of experience in delivering life. Lantheus provides a broad portfolio of products, including PYLARIFY ® (Piflufolastat F18), a PSMA PET imaging agent for the. This page is intended to serve as notice under 35 U. patents apply to our products: DEFINITY ® /DEFINITY. Lantheus Announces Top Rated Oral Presentation Featuring PYLARIFY AI™ at the 2023 European Association of Nuclear Medicine (EANM) Annual Meeting. This combination forms an innovative company with a diversified diagnostics and therapeutics portfolio,” said Mary Anne Heino, Lantheus President and Chief Executive Officer. The Company’s second quarter 2022 GAAP net income was $43. S. 29, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. U. 8 billion tied up in biobucks. In patients with. 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. For International Transportation Emergencies Call CC-BY-4. Lantheus Holdings Inc. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. It is the #1 PSMA PET Imaging. November 3, 2022 at 7:00 AM · 11 min read. 48 from the prior year period. Lantheus has offices in Massachusetts, New Jersey, Canada and Sweden. Read more about Lantheus Announces Top Rated Oral Presentation. PYLARIFY, AZEDRA, DEFINITY/LUMINITY, Xenon-133, NEUROLITE, TechneLite, Cardiolite, developmental products: United States. com. 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 is the largest growth driver for the company as it comprised 65% of. Efficacy: High-risk PCa: OSPREY COHORT A; Efficacy: Biochemically Recurrent PCa: CONDOR; Efficacy:. Lantheus says its technology can help improve the management of prostate cancer patients. Lantheus has multiple products on the market with two standouts driving the most growth with Pylarify and Definity. BEDFORD, Mass. Each milliliter contains 37 to 2,960 MBq (1 to 80 mCi) piflufolastat F 18 with ≤0. 4. , Sept. 8 million for the first quarter 2023, representing an increase of 44. Developed by Lantheus, PYLARIFY ® was recently approved by the 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. and Progenics Pharmaceuticals, Inc. Residents Only. 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. 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. It describes its PYLARIFY injection as “a radioactive diagnostic agent indicated. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the expansion of our Radiopharmaceutical Oncology pipeline. Lantheus Holdings, Inc. In the U. The following U. We accelerated our growth, diversified our portfolio, and delivered record revenues and profits which created additional free cash flows,” said Mary Anne Heino , President and Chief Executive Officer. Pylarify (piflufolastat), which was approved in 2021 by the Food and Drug Administration, is a. , Nov. 5 million, representing 61. “Today marks an important day for Lantheus and Progenics. Please enter your ZIP code to locate the nearest imaging site that offers PYLARIFY®. PYLARIFY injection 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 of recurrent and/or metastatic prostate cancer. S. 0 is commercially available in the United States . Lantheus Receives U. LinkedIn. Lantheus (LNTH) stock rose ~17% on Thursday after Q4 results beat estimates and the FY23 outlook was placed above expectations. S. S. The outlook from management for Pylarify growth was not what analysts -- who are are modeling this product out 2-3 years -- were expecting. LNTH is scheduled to release third-quarter 2023 results on Nov 2, before the opening bell. Based in North Billerica, Mass. 4% from the prior year period. PDF Version. Worldwide revenue of $321. NEW YORK, Jan. In the U. Lantheus presented study results providing independent validation of PYLARIFY AI™, the Company’s artificial intelligence (AI) platform developed to assist in standardized quantification of. Further support is available from your local Lantheus account manager or the PYLARIFY® Reimbursement Hotline. Lantheus Receives U. Heino , President and Chief Executive Officer of Lantheus . 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. diagnostic radiopharmaceutical. PET/CT. Lantheus Announces Presentations Featuring PYLARIFY AI™ at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting June 12,. 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. 47, as compared to $0. For the full year 2022, Lantheus forecasts PYLARIFY to be in a range of $300M to $325M and their. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 1 million in the prior year period; GAAP fully diluted net income per share of $1. The company's. 1. 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. For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®. 4% from the prior year period. (NASDAQ:NASDAQ:LNTH) Q4 2021 Earnings Conference Call February 24, 2022 8:00 AM ETCompany ParticipantsMary Anne Heino – President and Chief Executive Officer Mark. with suspected recurrence based on. , Nov. 4% from the prior year period; GAAP net income of $43. With 3 million men living with prostate cancer and more than 18. -1. Lantheus Holdings, Inc ( LNTH 0. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans. 1 million for the second quarter 2023, compared to GAAP net income of $43. "2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and the. , Nov. 28 May, 2021, 07:00 ET. Lantheus Holdings markets a fluorine-18 (F18) PSMA PET imaging product called Pylarify, for instance, which was approved last year. , Progenics Pharmaceuticals, Inc. In the last reported quarter, Lantheus earnings per share (EPS) of $1. Lantheus Medical Imaging has received approval from the U. 3. Sanchez-Crespo A. 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. Pylarify is an injectable agent that helps highlight prostate cancer under a PET scan. Patient-Level, Region-Matched Performance of PYLARIFY PET for Detection of Pelvic Lymph Node Metastasis in Trial 1 (n=252). S. is the parent company of Lantheus Medical Imaging, Inc. 15. PYLARIFY works with PET/CT technology to produce a combined PET/CT scan that enables the reader of the PET/CT scan to detect and locate the disease. com. DEFINITY closed out 2022 with $245 million of net sales, an increase of 5. The. Lantheus Holdings, Inc. , Nov. Lantheus Reports Second Quarter 2023 Financial Results. Eastern Time. Lantheus Holdings Inc (NASDAQ:LNTH) made significant progress during the quarter with PYLARIFY and DEFINITY in its commercial portfolio, and with PNT2002 and MK-6240 in its pipeline. Food and Drug Administration in May 2021. PYLARIFY –Prostate Cancer Franchise Overview Paul Blanchfield, Chief Commercial Officer Etienne Montagut, Chief Business Officer Aseem Anand, VP of Digital Solutions PYLARIFY Key Opinion Leader Panel Moderator: Bela Denes, M. PYLARIFY® FOR PCa IMAGING; EFFICACY AND SAFETY. Furthermore, Lantheus’ management has once again tightened the revenue guidance for FY23 while also increasing the EPS. S. 86 per fully diluted share, as compared to GAAP net loss 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. NORTH BILLERICA,. ET. Melissa Downs Senior Director, Corporate Communications 646. Food and Drug Administration (FDA) for Pylarify (F-18 DCFPyL), a PET radiopharmaceutical designed to target prostate-specific membrane antigen (PSMA). Enrollment and participation is free, and does not impose any requirements on the manner in which the facility provides service to patients. INDICATION. The company reports earnings on November 3, with analysts expecting the company to top last year's results. “The transaction leverages Lantheus’. 1 million for the second quarter of 2021, representing an increase of 121. 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY ®, a PSMA PET imaging. 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. PYLARIFY® (piflufolastat F18) injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancer. with suspected recurrence based on. It was the Progenics deal that took Lantheus into radiotherapeutics, though at the time the $400m move was not especially well received. 331 Treble Cove Road . 8M of net sales while cardiovascular ultrasound enhancement. S. Syntermed announces its appointment by Lantheus Holdings, Inc. Lastly, net cash provided by operating activities was $116. PYLARIFY may be diluted with 0. In the U. Lantheus' Key Products Driving Growth. 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. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Before that Lantheus, which has operated since the 1950s, relied on established businesses in microbubbles and spect imaging. PYLARIFY, approved by the FDA in May 2021, is the first commercially and widely available prostate-specific membrane antigen (PSMA) PET imaging agent. PDF Version. . Product Uses . The. 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. 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. disease. Lantheus Receives U. 3. 2. S. 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. Lantheus Holdings on Thursday reported Q4 adjusted net income of $1. S. Nominee: Lantheus’ PYLARIFY injection and PYLARIFY AI. , May 11, 2022 (GLOBE NEWSWIRE) -- Lantheus. Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium Demonstrate Potential Benefits of. com. 3 million for the third quarter 2022, representing an increase of 134. 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. MarketBeat Follows Only 4 people have added Lantheus to their MarketBeat. , June 12, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. GAAP fully diluted earnings per share were $1. 6% and an increase of 25. S. Assay the dose in a suitable dose calibrator prior to administration. 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. PYLARIFY® IS UNIQUE. , Lantheus was founded in 1956 and formerly owned by Bristol Myers. Contact information For media. Do not use if it contains particulate matter or if it is discolored (PYLARIFY is a clear, colorless solution). Lantheus Receives U. Lantheus Holdings, Inc. 1-800-299-3431. 7 million in the same period last year. S. (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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY ® Vial for (Perflutren Lipid Microsphere) Injectable. S. “Lantheus is leading the way in harnessing the power of AI and machine learning technologies, together with our game-changing PSMA-targeted PET imaging agent PYLARIFY, to potentially transform. 4 million in revenue, up 25% year over year, and a net loss of $11. Lantheus Holdings. , VP, Medical Affairs E. 's (LNTH) PYLARIFY injection, a prostate specific membrane antigen-targeted positron emission tomography imaging agent, has been approved by the FDA. 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 FDA in May of 2021 and is commercially available as PYLARIFY ® (Piflufolastat F 18 Injection) and sold by Lantheus. Please refer to the map below for the production site nearest you. (LNTH) CEO Mary Anne Heino on Q2 2021 Results - Earnings Call Transcript. 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. COMPANY IDENTIFICATION: Progenics Pharmaceuticals, Inc. 1-800-299-3431. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to innovative. 7% year-over-year growth and approximately 8% sequential growth from the first quarter of 2023, with the vast majority of our sequential growth driven by our existing accounts. 1 million, or $0. 0% from the prior year period. m. 47, as compared to $0. 50 from the prior year period. PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. “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. Food and Drug Administration (May 2021) as the first and only commercially available, approved PSMA PET imaging agent for prostate cancer. 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. “2022 was an outstanding year for Lantheus, led by the success of PYLARIFY and expansion of our Radiopharmaceutical Oncology pipeline. In the second full quarter for both products in the market, PYLARIFY -- Lantheus -- reported $35. Senior Director, Investor Relations. Global Data 3rd line treatment for metastatic castration-resistant prostate cancer (“mCRPC”), Lantheus primary market research informing imaging procedures performed during radioligand treatment. 4% from the prior year period ; GAAP net income of $61. 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. , a Lantheus company 331. Accessed May 11, 2022. 9 million, up 33. In hindsight it appears that the sellside failed to appreciate Pylarify's potential. 9 million for the first quarter 2022, representing an increase of 125. “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. Billerica, MA 01862 . 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. PYLARIFY AI is the first and only FDA-cleared Artificial Intelligence-Enabled PSMA – a truly game-changing product. with suspected recurrence based on elevated serum levels of prostate-specific antigen (PSA) level. , a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and. About Lantheus Holdings, Inc. 1% over the. PYLARIFY identifies PSMA, the. Now turning to cash flow. “In addition to FDA approval, inclusion in the guidelines.