RTX-1363S

BEDFORD, Mass., June 11, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced the presentation of new data highlighting two oncology radiodiagnostic agents will be presented at the upcoming 2025 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, taking place June 21-24, 2025, in New Orleans, LA. Presentation details are as follows: Oral Presentations Date & Time: Tuesday, June 24, 2025; 2:30 – 3:35 PM CT Session Number: SS39 Session Title: Advancing Radiopharmaceutical Production, Quality Control, and Translational Readiness Title: Optimized Production and Quality Control of the FAP imaging Agent [ 64 Cu]LNTH-1363S Presenter: Gengyang Yuan, Lantheus Poster Presentations Date & Time: Sunday, June 22, 2025; 5:30 – 6:15 PM CT Session Number: MTA03 Session Title: Oncology: Clinical Diagnosis & Therapy Meet the Author Session, part 1 Title: 18 F-Piflufolastat PET/CT in Patients with Biochemically Recurrent Prostate Cancer: a CONDOR Sub-analysis of Positive Predictive Value in the Prostate/Prostatic Bed Stratified by PSA Presenter: Amir Iravani, University of Washington Date & Time: Monday, June 23, 2025; 10:30 – 11:15 AM CT Session Number: MTA06 Session Title: Oncology: Discovery & Translational Meet the Author Session Title: First Clinical Evaluation of 68Ga-LNTH-1363S, a Novel FAP-Targeting Radiopharmaceutical for PET Imaging: Physiological Biodistribution and Tumor Uptake in Cancer Patients Presenter: Ida Sonni, University of California, Los Angeles Date & Time: Tuesday, June 24, 2025; 8:00 – 9:15 AM CT Session Number: SS27 Session Title: Emerging Role of Fibroblast Activation in Cardiovascular Imaging Title: Preclinical assessment of 64Cu-LNTH-1363S for FAP PET imaging in mouse models of myocardial infarction Presenter: Gyu Seong Heo, Department of Radiology, Washington University About PYLARIFY ® (piflufolastat F 18) Injection 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. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. 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. 1-6 PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 500,000 scans across 48 states. 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: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Important Safety Information Contraindications None. Warnings and Precautions Risk of Image Misinterpretation Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. 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. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Hypersensitivity Reactions Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available. Radiation Risks Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. Adverse Reactions The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions. Drug interactions Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established. To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Please read the accompanying full Prescribing Information also available at PYLARIFY.com . About Lantheus Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Switzerland and Sweden, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. For more information, visit www.lantheus.com . 1 PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company. 2 Data on file. Bedford, MA: Progenics Pharmaceuticals, Inc.; 2024. 3 Mena E, Lindenberg ML, Turkbey IB, et al. 18 F-DCFPyL PET/CT imaging in patients with biochemically recurrent prostate cancer after primary local therapy. J Nucl Med . 2020;61(6):881-889. 4 Werner RA, Derlin T, Lapa C, et al. 18 F-labeled, PSMA-targeted radiotracers: leveraging the advantages of radiofluorination for prostate cancer molecular imaging. Theranostics . 2020;10(1):1-16. 5 Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol . 2019;11:1-14. 6 Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging . 2020;20(1):10. Contacts: Lantheus Mark Kinarney Vice President, Investor Relations 978-671-8842 ir@lantheus.com Melissa Downs Executive Director, External Communications 646-975-2533 media@lantheus.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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BOSTON and BOCA RATON, Fla., March 12, 2024 /PRNewswire/ -- Ratio Therapeutics Inc. (Ratio), an emerging pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, today announced an expanded manufacturing agreement with PharmaLogic, a world-class contract development and manufacturing organization (CDMO) specializing in radiopharmaceutical production and distribution. The collaboration aims to significantly accelerate the development and commercialization of Ratio's pipeline of next-generation radiotherapies, representing a critical component in advancing Ratio's fibroblast activation protein-alpha (FAP)-targeted radiotherapeutic candidate. Continue Reading Logos for PharmaLogic and Ratio Therapeutics. "We are excited to partner with PharmaLogic, an industry-leading CDMO with over 15 years of experience in radiopharmaceutical manufacturing and supply chain solutions," said Dr. Matthias Friebe, Chief Technology Officer of Ratio. "With advanced facilities, substantial capacity, and an impressive track record of quality and compliance, PharmaLogic has demonstrated their ability to reliably produce highly complex radiopharmaceutical products. Their expertise in sophisticated technologies such as accelerated radiochemistry and automation will ensure efficient, scalable production of our novel pipeline therapies to meet future commercial demands. This collaboration represents a major step towards Ratio Therapeutics' mission of discovering and rapidly transitioning innovative radiopharmaceuticals to the clinic, aiming to transform treatment paradigms and improve patient outcomes." "We are honored to collaborate with Ratio Therapeutics and support their pipeline of precision-targeted radiotherapies," said D. Scott Holbrook, Chief Strategy Officer and General Manager at PharmaLogic. "Ratio is at the forefront of developing radiopharmaceutical solutions that have the potential to significantly improve patient outcomes. By leveraging our combined expertise and manufacturing capabilities, we aim to make these cutting-edge therapies readily available to patients in need." Ratio, in collaboration with Lantheus and PharmaLogic, is currently conducting a Phase I trial evaluating the efficacy of a novel FAP-targeted imaging biomarker, copper-64[Cu-64]-labeled LNTH-1363S (formerly RTX-1363S) for PET imaging in adult healthy volunteers. The company also recently announced a $50M Series B financing which will significantly drive the clinical advancement of Ratio's first FAP-targeted therapeutic candidate into clinical trials this year. About PharmaLogic PharmaLogic is a world-class contract development and manufacturing company specializing in novel diagnostic imaging and therapeutic radiopharmaceuticals for the treatment of cancers and other malignancies. In addition to an established and reliable network of radiopharmacies, PharmaLogic has decades of expertise in drug development from discovery, through manufacturing and commercialization. The company seeks to take the lead in the advancement of radiopharmaceutical technology for the benefit of patients worldwide. For more information, visit: radiopharmacy.com About Ratio Therapeutics Ratio Therapeutics Inc. is a clinical-stage pharmaceutical company on a mission to accelerate the discovery and development of next-generation precision radiopharmaceuticals that will transform treatment paradigms for solid tumors. The company's proprietary R&D platforms, TrilliumTM and MacropaTM, enable the development of tunable radiopharmaceuticals for therapy and imaging. This tunability enables pharmacokinetic modulation to enhance tumor loading of radioactivity and improve the therapeutic index. Headquartered in Boston with integrated laboratories supporting internal discovery efforts, Ratio employs a growing team of multidisciplinary experts possessing extensive experience in radiopharmaceutical research and development. The company is currently advancing its lead FAP-targeted radiotherapeutic candidate for the treatment of soft tissue sarcoma, with plans to initiate clinical trials in late 2024. Please visit for more information and follow us on Twitter (X) and LinkedIn. SOURCE PharmaLogic Holdings Corp