Blue Earth Therapeutics Ltd.

Standard treatment for many autoimmune diseases includes drugs that suppress the immune system. Even when this approach works (and it doesn’t work for everyone), chronic immunosuppression puts patients at risk of infections among other complications. Nuvig Therapeutics is developing a first-in-class drug that could offer an alternative treatment for autoimmune diseases and the startup now has $161 million to advance clinical development of its lead program. Nuvig aims to treat autoimmune disease by tapping into a built-in mechanism of the body that tamps down inflammatory pathways. The Menlo Park, California-based company’s drugs are proteins engineered to bind to type II Fc receptors, a class of receptors that regulate immune responses. The company says the binding of its drug to these receptors leads to the expansion of regulatory T cells, or Tregs, a type of immune cell that suppresses immune responses. This approach also downregulates numerous inflammatory pathways . Lead Nuvig program NVG-2089 has Phase 1 results showing it was safe and well tolerated. Also important, the results showed the drug engaged its target. In Phase 2, Nuvig will test NVG-2089 as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP), a rare disorder in which the immune system attacks myelin, the protective sheath covering nerve fibers. This disease leads to nerve and motor problems as well as progressively worsening muscle function. Consumer / Employer Health Executives on Digital Transformation in Healthcare Hear executives from Quantum Health, Surescripts, EY, Clinical Architecture and Personify Health share their views on digital transformation in healthcare. By MedCity News Standard CIDP treatment includes intravenous immunoglobulin (IVIg), an infusion of antibodies sourced from healthy donors. This treatment provides a patient with antibodies that block the inflammatory processes that damage myelin. Immunosuppressants are another CIDP treatment option. Not all patients respond to these therapies, but there’s already a new alternative. This past June, the FDA expanded the approval of Argenx drug Vyvgart Hytrulo to include CIDP. This injectable drug, which was initially approved to treat generalized myasthenia gravis, is an antibody fragment designed to bind to and block the neonatal Fc receptor (FcRn). Consequently, disease-driving autoantibodies go to a cellular system that degrades proteins. Through the first three quarters of 2024, Argenx reported more than $1.4 billion in product sales, a 77.5% increase over the same period in 2023. These figures includes Vyvgart, the original intravenously infused formulation of the FcRn inhibitor. Argenx has touted its drug’s potential uses in a wide range of autoimmune indications and the company is in various stages of clinical development testing its FcRn-blocker in multiple diseases. Similarly, Nuvig says its drug has the potential to address many autoimmune indications. But first, the company will see how its drug works in CIDP. Nuvig chose CIDP because it is an indication where IVIg is the standard of care and there is still unmet need for a better-tolerated therapy that is not immunosuppressive, co-founder and Chief Scientific Officer Pamela Conley said in an email. She added that her company’s approach is distinct from that of the Argenx drug and other FcRn inhibitors. Most autoimmune diseases, including CIDP, are not entirely mediated by the presence of autoantibodies, she explained. Rather, most of the damage in CIDP is mediated by immune cells that infiltrate the myelin that protect nerve cells. An FcRn blocker like Argenx’s drug does nothing to reduce the infiltration of immune cells into myelin, Conley said. Furthermore, blocking FcRn leads to an up to 80% reduction in overall circulating antibodies. Chronic maintenance of these low antibody levels is immunosuppressive, putting patients at risk of infection. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions Rather than being immunosuppressive, Nuvig’s drug is immunomodulatory, Conley said. The drug offers a broader approach by down regulating the response of immune cells that drive inflammation while also expanding and activating Tregs, which is similar to what happens with IVIg. Conley added that clinical tests of the Argenx drug showed the overall response of CIDP patients was less than what has been observed in CIDP studies with IVIg. “We believe that the [mechanism of action] of NVG-2089 will lead to greater efficacy in CIDP than what was observed with Vyvgart,” Conley said. Nuvig, which is based on research from The Rockefeller University, emerged from stealth in 2022 backed by a $47 million Series A round. The new Series B round was co-led by Sanofi Ventures, Blue Owl Healthcare Opportunities (formerly Cowen Healthcare Investments), and Norwest Venture Partners. Other participants include new investors B Capital, Leaps by Bayer, Global BioAccess Fund, LOTTE Holdings, Alexandria Venture Investments, and funds managed by abrdn Inc., as well as earlier investors Novo Holdings, Platanus, Bristol Myers Squibb, Digitalis Ventures, and Mission BioCapital. Here’s a recap of other recent biotech financing news: —Metabolic medications biotech Antag Therapeutics raised €80 million (about $80.6 million) to enter the clinic with obesity drug candidate AT-7687, a peptide designed to block the GIP receptor. The drug is based on an endogenous GIP receptor antagonist. The drug is intended to be dosed alongside current or future obesity drugs, including those that block the GLP-1 receptor. Compared to other drugs being developed to block GIP, Antag says its approach offers flexibility in dosing that could improve both efficacy and tolerability. The drug could also be used by itself as a maintenance treatment. In tests in monkeys, Antag said AT-7687 dosed with a GLP-1 drug produced “best-in-industry weight loss” along with improved glycemic control and lipid profiles that were independent of weight changes. Antag added that these benefits were achieved without gastrointestinal side effects. The biotech’s pipeline includes drug combinations for other targets and a follow-on molecule that could offer monthly dosing. Versant Ventures led Antag’s Series A financing. —Maze Therapeutics raised $115 million to advance clinical development of its two lead programs. MZE829, an oral drug designed to block a protein called APOL1, is on track to Phase 2 testing in the rare kidney disease focal segmental glomerulosclerosis. MZE782, an oral inhibitor of SCL6A19, is on in Phase 1 testing; South San Francisco-based Maze plans to evaluate it in chronic kidney disease and phenylketonuria. Maze’s Series D round was co-led by Frazier Life Sciences and Deep Track Capital. —Adcendo, a developer of antibody drug conjugates for cancer, recently received FDA clearance to begin a Phase 1/2 test of ADCE-D01 in patients with advanced soft tissue sarcoma. Now it has $135 million to fund the clinical research. ADCE-D01 is designed to target uPARAP, a receptor that’s overexpressed in mesenchymal cancers, including subtypes of soft tissue sarcoma. Copenhagen-based Adcendo earlier this year expanded its Series A round of funding to €98 million (about $102.5 million). The new round, a Series B financing, was led by TCGX. —Kanglin Biotechnology unveiled $20 million in Series A financing to advance to clinical development with lead program, KL003, a gene therapy for the rare blood diseases beta thalassemia and sickle cell disease. Those diseases are already addressed by FDA-approved gene therapies from Vertex Pharmaceuticals and Bluebird Bio. Hangzhou, China-based Kanglin claims its lentiviral vector-based therapy can be best in class with shorter time to transfusion independence and engraftment of the genetically modified cells. No investor details were disclosed. —35Pharma raised $53 million to support clinical development of HS135 for pulmonary hypertension and HS235 for cardiometabolic disease and obesity. Both drugs are fusion proteins designed to block activins and growth differentiation factors (GDFs), proteins associated with many diseases. Frazier Life Sciences led the Series C round for Montreal-based 35Pharma. —Startup Valora Therapeutics emerged with $30 million to advance the development of a new class of drugs it calls antibody lectin chimera, or AbLecs. These engineered antibodies target the glycol-immune checkpoint, blocking glycans, sugar molecules on the surface of cells, from interacting with lectins. This approach has potential applications to cancer and autoimmune disease. Avalon BioVentures co-led the seed round of San Diego-based Valora. —Enveda raised $130 million to support its pipeline of 10 programs and multiple discovery candidates, all from an AI technology platform that applies machine learning techniques to metabolomics data. In October, the Boulder, Colorado-based company began a Phase 1 study of ENV-294, a potential oral anti-inflammatory drug for atopic dermatitis and other inflammatory disorders. Kinnevik and FPV led the Series C round, which brings the company’s funding total to $360 million. —TRexBio closed $84 million to advance its lead internal program, TRB-061, through early clinical development. The drug is an agonist of the TNFR2 receptor, which is abundant on regulatory T cells in the skin and gut. TRB-061 is a potential treatment for atopic dermatitis and ulcerative colitis; a Phase 1 study is on track to begin in the first half of 2025. Delos Capital led TRexBio’s Series B financing. —Wellington Management and Venrock led the $215 million financing of Metsera, a clinical-stage developer of metabolic disorder drugs. The Series B round comes seven months after Metsera launched backed by $290 million. The most advanced program of the New York-based company is a long-acting GLP-1 drug administered once-monthly — a key dosing edge over currently available GLP-1 drugs that patients must inject once weekly. Metsera expects to report preliminary Phase 2 data in the first half of 2025. —Alentis Therapeutics raised $181.4 million for clinical development of two antibody drug conjugates. ALE.P02 is on track to begin Phase 1/2 testing in advanced CLDN1-positive squamous solid tumors. ALE.P03 is being readied to enter the clinic in patients with CLDN-positive tumors. Alentis last raised money in 2023, a $103 million Series C round. Orbimed led the latest round, a Series D financing, along with co-leads Novo Holdings and Jeito Capital. —Arda Therapeutics raised $43 million to take a new approach to treating chronic disease. Rather than modulating the activity of proteins produced by cells that drive disease, San Francisco-based Arda is developing targeted biologic drugs that deplete those cells. Andreessen Horowitz led Arda’s Series A financing. —Evommune raised $115 million as the biotech prepares for upcoming data readouts for two skin disease drugs. Lead program EVO756 is on expected to report data in the first half of 2025 from a Phase 2 test in chronic inducible urticaria. Phase 2 tests are also planned for EVO756 in chronic spontaneous urticaria and for EVO301 in atopic dermatitis. Data from these tests are expected in 2026. RA Capital Management and Sectoral Asset Management led the Palo Alto-based biotech’s Series C financing. —Trace Neuroscience launched with $101 million and a lead program in development for amyotrophic lateral sclerosis (ALS). The South San Francisco-based biotech says its antisense oligonucleotide drug restore a protein called UNC13A, which in turn reestablishes healthy communication between nerves and muscle cells that are affected by neurodegenerative disorders. Third Rock Ventures led Trace’s Series A financing. —Axonis Therapeutics has $115 million to support a lead program in development for treating epilepsy and pain. The Boston-based company’s drug candidate, AXN-027, targets KCC2, a chloride transporter in the central nervous system that is essential for inhibitory neurotransmission. It’s the same target being pursued by Ovid Therapeutics, which acquired its KCC2-targeting molecules from AstraZeneca. Cormorant Asset Management and venBio Partners co-led Axonis’s Series A financing. —Blue Earth Therapeutics announced its presence in the growing radiopharmaceuticals sector with a $76.5 million Series A round. The Oxford, U.K.-based company will apply the proceeds toward Phase 2 tests of its radioligand therapies that target PSMA, the same protein hit by Novartis radiopharmaceutical Pluvicto. Soleus Capital led the round, which was co-led by Sands Capital Management. —Archon Biosciences, a Seattle startup from the University of Washington lab of Nobel Prize-winning scientist David Baker, emerged with $20 million and a platform technology that designs antibodies in a way that controls their structure. These antibody cages, or AbCs, can control how a drug distributes in the body to potentially offer advantages in safety and potency. Madrona Ventures led Archon’s seed financing. —Kivu Bioscience launched with $92 million, revealing antibody drug conjugates and technology licensed from Lonza subsidiary Synaffix. The startup, named for Lake Kivu in Africa, isn’t disclosing its cancer targets, but it plans to advance its lead program into Phase 1 testing in 2025. Novo Holdings led Kivu’s Series A financing. —Agomab raised $89 million to support ongoing clinical testing of AGMB-129, which is in development as a potential treatment for fibrostenosing Crohn’s disease. In this complication of the inflammatory gut disorder, scar tissue (fibrosis) and inflammation lead to thickening of the bowel. The Antwerp, Belgium-based biotech’s drug is a small molecule designed to block ALK5, a protein involved in a signaling pathway associated with fibrosis. Agomab’s Series D round added new investors Sanofi and Invus. —Pathos AI raised $62 million as it plans to advance to mid-stage clinical development. P-500, one of two clinical-stage assets the biotech acquired in the past year, is a brain-penetrating small molecule inhibitor of a target called PRMT5. The Chicago-based company says it will use its AI-powered technology to make patient selection and clinical trial design decisions. New Enterprise Associates led Pathos AI’s Series C round. —With a lead drug candidate in Phase 1/2 testing and a new program on its heels, B-cell therapies developer Be Biopharma raised $82 million in Series C financing. The Cambridge-based biotech’s technology engineers B cells to produce therapeutic proteins. Its most advanced program, BE-101, is in development for treating hemophilia B. The next program is BE-102, a potential treatment for hypophosphatasia, a rare inherited disorder that leads to weak bones and teeth. Be Bio last raised money in 2022, a $130 million Series B round. Picture: Feodora Chiosea, Getty Images

关注并星标CPHI制药在线 当前，全球创新药研发领域呈现出蓬勃发展的态势。多家新锐公司成功完成新一轮融资，涵盖了干细胞药物、核酸药物、小分子药物、靶向放射性配体疗法、抗体偶联药物（ADC）等多种药物类型。这些创新药物针对的疾病范围广泛，包括癌症、糖尿病、肥胖、细菌感染以及癫痫等多种疾病，为全球患者带来了新的治疗希望。本文将盘点几家具有代表性的海内外融资公司及其聚焦领域。 一 中国新药公司融资 1. 宁丹新药：C轮融资数亿元，聚焦中枢神经系统疾病 11月1日，宁丹新药宣布完成数亿元人民币的C轮融资，本轮融资由南京江宁高新区科创投和华兴康平一起合作进行。 宁丹新药的在研管线主要用于治疗卒中、颅内肿瘤、认知障碍、情感障碍、神经病理性疼痛、脑小血管病等多个高发中枢相关疾病。其中，进展最快的项目Y-2是与先声药业合作开发的依达拉奉右莰醇舌下片，这是一款脑卒中改良型创新药物，NMPA已经批准其在中国的上市，第一个适应症主要用于调节AIS所致的神经症状、日常生活活动能力和功能障碍。 宁丹新药在一年内连续完成B轮和C轮融资，显示出资本市场对其研发实力和市场前景的高度认可。未来，宁丹新药将继续加大在中枢神经系统疾病领域的研发投入，推动更多创新药物上市，为患者带来福音。 2. 柯君医药：B+轮融资，专注小分子及核酸药物研发 10月31日，柯君医药宣布完成B+轮阶段性融资。本轮融资由国信创新股权领投，其它主要投资方包括谊安集团及英飞尼迪资本等，原有投资者宏海资本也持续追加投资。 柯君医药成立于2018年，专注于小分子及核酸药物研发，目前主要聚焦心脑血管疾病和抗病毒等治疗领域。该公司自主研发的新一代抗血小板药物CG-0255是一款创新型的P2Y12受体拮抗剂，采用了全新设计的代谢路径，目前已经在美国完成注射和口服两种剂型的1期临床试验，在中国也已提交了临床开发申请。 柯君医药凭借其在小分子及核酸药物研发领域的深厚积累，不断推动创新药物的研发进程，为医疗健康行业注入新的活力。 二 海外新药公司融资 1. Evommune公司：C轮融资1.15亿美元，聚焦免疫介导的炎症性疾病 11月1日，Evommune公司宣布完成1.15亿美元C轮融资。此次融资由新投资者RA Capital Management和Sectoral Asset Management共同领投。 Evommune是一家临床阶段的生物技术公司，聚焦发现和开发治疗免疫介导的炎症性疾病的新方法。本轮融资所得款项将用于支持Evommune公司主打项目EVO756以及EVO301的临床开发。 EVO756是一种口服方式的MRGPRX2小分子拮抗剂，技术原理是通过阻断MRGPRX2和肥大细胞颗粒释放，这个药在治疗多种肥大细胞介导的疾病方面有很好的效果。EVO301是一种长效、与血清白蛋白结合的融合蛋白注射疗法，旨在中和IL-18信号通路，从而调节多种慢性炎症疾病。 Evommune公司在免疫介导的炎症性疾病领域取得了显著进展，其创新药物的临床开发前景广阔。未来，随着更多资金的注入，Evommune将继续加大研发投入，推动创新药物的上市，为全球患者提供更多治疗选择。 2. Archon Biosciences：种子轮融资2000万美元，利用AI驱动蛋白设计 10月31日，Archon Biosciences宣布走出隐匿模式，并完成2000万美元种子轮融资。该公司的技术平台利用了人工智能（AI）驱动的计算蛋白设计方面的进展，此项技术因在创建具有特定功能的新蛋白方面的能力而被授予2024年诺贝尔化学奖。诺奖得主David Baker博士是该公司的联合创始人之一。 Archon Biosciences致力于设计一种称为抗体笼（antibody cage, AbC）的全新生物制品类型。它由抗体和一组在大自然中不存在的AI生成蛋白结构域组合而成。对AbC结构的精准控制可以调节其在体内的分布方式以及与细胞靶点的高特异性和高效性相互作用。 Archon Biosciences将生成式蛋白设计直接应用于药物开发，不仅设计，而且迅速制造出新分子实体以供临床前研究。这种创新的技术平台为药物研发带来了全新的可能性，有望推动医疗健康行业的变革。未来，Archon Biosciences将继续利用AI驱动的计算蛋白设计技术，开发更多创新药物，为全球患者带来更多希望。 3. Blue Earth Therapeutics：A轮融资7650万美元，推进前列腺特异性膜抗原靶向放射性配体疗法 10月31日，Blue Earth Therapeutics宣布完成7650万美元A轮融资，本轮融资由Soleus Capital领投，Sands Capital Management联合领投，现有投资者Bracco Imaging也参与其中。 Blue Earth Therapeutics的放射性配体分子由四个不同的结构域组成，其中第一个结构域是靶向前列腺特异性膜抗原（PSMA）的配体，连接有两个可标记的结构域，这些结构域可以用治疗性同位素如177Lu或225Ac标记成为放射性配体疗法。 Blue Earth Therapeutics在前列腺特异性膜抗原靶向放射性配体疗法领域取得了重要进展，其创新药物的临床开发前景广阔。未来，随着更多资金的注入，Blue Earth Therapeutics将继续加大研发投入，推动创新药物的上市，为全球前列腺癌患者提供更多治疗选择。 三 其他值得关注的融资公司 1. 瑞普晨创：A轮融资超亿元，拓展细胞疗法应用 11月1日，瑞普晨创宣布完成超亿元A轮融资。本轮融资由中国风投领投，贝达药业、联想创投、荷塘创投、贝橙创投等跟投。贝达药业也同步宣布与瑞普晨创完成签署《战略合作协议》，双方将合作开发干细胞治疗业务，在人多能干细胞向胰岛细胞诱导分化技术领域展开深入合作。 瑞普晨创由丁列明博士和邓宏魁教授领衔，致力于拓展细胞疗法在多种重大、疑难疾病领域的应用。该公司自主研发的治疗1型糖尿病的多能干细胞产品RGB5088胰岛细胞注射液的临床试验申请（IND）也已获得中国NMPA受理。 瑞普晨创在细胞疗法领域取得了显著进展，其创新药物的临床开发前景广阔。未来，随着更多资金的注入和合作伙伴的加入，瑞普晨创将继续加大研发投入，推动创新药物的上市，为全球患者提供更多治疗选择。 2. Leal Therapeutics：4500万美元融资，推进中枢神经系统疾病药物研发 10月31日，Leal Therapeutics宣布完成4500万美元融资。本轮融资由Newpath Partners领投。 Leal公司成立于2021年，致力于为中枢神经系统疾病患者提供新型精准药物。本轮融资获得资金将用于推进该公司针对中枢神经系统疾病患者的反义寡核苷酸（ASO）和小分子疗法产品管线。 Leal的主要在研项目包括LTX-002，一款治疗遗传性或散发性肌萎缩侧索硬化（ALS）患者的ASO疗法，以及LTX-001，一款针对精神分裂症患者的小分子药物。该公司计划在2024年底前提交LTX-002和LTX-001的IND申请，并在2025年初启动首次人体临床试验。 Leal Therapeutics在中枢神经系统疾病药物研发领域取得了重要进展，其创新药物的临床开发前景广阔。 四 结语 创新药的研发是推动医疗健康行业进步的重要力量。海内外多家聚焦创新药研发的新锐公司宣布完成新一轮融资，随着更多资金的注入和技术的不断创新，这些新药公司将继续推动创新药物的研发进程，为全球医疗健康行业的发展贡献更多力量。 参考文献 1.医药观澜. 2.即刻药数数据库. END 【智药研习社线上研习会报名】 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

MONROE TOWNSHIP, N.J., & OXFORD, England--( BUSINESS WIRE )--Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, welcomes changes announced by the Centers for Medicare & Medicaid Services (CMS) for the Hospital Outpatient Prospective Payment System (OPPS) Rule on November 1, 2024. The rule, which goes into effect January 1, 2025, is designed to improve payments for diagnostic radiopharmaceuticals for U.S. Medicare patients, and has the potential to increase sustained access to innovative radiopharmaceuticals. “ We are very pleased that CMS has updated this rule, which will increase patient access to advanced diagnostic imaging products to inform patient management and treatment,” said Marco Campione, Chief Executive Officer of Blue Earth Diagnostics. “ This action will foster additional innovation and sustainability in nuclear medicine and molecular imaging, aligning with our company commitment to deliver leading-edge radiopharmaceutical solutions for improved patient care.” “ Since its inception, Blue Earth Diagnostics has championed the need for reimbursement reform around CMS payment methodology for diagnostic radiopharmaceuticals. This rule corrects a significant reimbursement gap that previously hampered the adoption of innovative radiopharmaceutical products, and patient access,” said Terri Wilson, President, Blue Earth Diagnostics. “ It supports Blue Earth Diagnostics’ entire portfolio of diagnostic imaging agents. POSLUMA ® (flotufolastat F 18) maintains its current Pass-Through payment status until September 30, 2026. Axumin ® (fluciclovine F 18), which previously lost Pass-Through status in January 2020, will regain separate payment under this new rule. Although the updated payment methodology provides for separate payment for diagnostic radiopharmaceuticals, payment will differ for Pass-Through and non-Pass-Through diagnostic radiopharmaceuticals. Our field reimbursement team continues to work with hospitals to ensure they understand the new rule and its implications.” Indication and Important Safety Information About Axumin INDICATION Axumin ® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended. Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available. Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers. Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia. To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf . Indication and Important Safety Information About POSLUMA INDICATION POSLUMA ® (flotufolastat F 18) injection is 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 Image interpretation errors can occur with POSLUMA PET. 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 POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. 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 flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf . About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com . PP-rh-US-0581 This press release is for U.S. audiences only