Flotufolastat F-18

Pharmaceutical licensing collaboration1.Novartis Inks Over $2 Billion Deal On October 28th, Monte Rosa Therapeutics has announced a collaboration with Novartis, granting Novartis exclusive global rights to develop, manufacture, and commercialize MRT-6160 and other molecular glue protein degraders targeting VAV1. Under the agreement, Monte Rosa will receive $150 million upfront and is eligible for up to $2.1 billion in development, regulatory, and sales milestone payments. MRT-6160 is a potent, highly selective oral VAV1 degrader with potential as a treatment for immune-mediated diseases, including multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, and dermatological disorders. The compound is currently in a Phase I clinical trial in healthy volunteers. 2.AbbVie Acquires CNS Start-Up in $1.4 Billion Deal On October 28th, AbbVie and Aliada Therapeutics have reached a definitive agreement under which AbbVie will acquire Aliada for approximately $1.4 billion, gaining access to its lead Alzheimer's disease (AD) therapy, ALIA-1758. The acquisition is expected to close in Q4 2024. Aliada is focused on developing innovative treatments for central nervous system (CNS) diseases utilizing a novel blood-brain barrier (BBB) crossing technology. ALIA-1758, which uses this novel delivery technology to transport anti-3pE-Aβ antibodies across the BBB via TfR targeting, is currently in Phase I clinical trials. 3.Biogen Embarks on $1.45 Billion Molecular Glue Collaboration On October 29th, Biogen and Neomorph have announced a research collaboration aimed at discovering and developing molecular glue degraders for the treatment of Alzheimer’s disease and rare neurological and immune system disorders. Neomorph will receive up to $1.45 billion in upfront and milestone payments under the agreement. Neomorph specializes in developing molecular glue protein degraders for “undruggable targets,” and the partnership will leverage Neomorph’s proprietary platform to expedite the identification and validation of new small-molecule therapeutic molecular glue degraders. Biogen will oversee the clinical development and potential commercialization of the lead candidates. 4.GSK Acquires Chimagen T-Cell Engager (TCE) for $850 Million On October 29th, GlaxoSmithKline (GSK) has announced an acquisition of Chimagen’s T-cell engager (TCE) product CMG1A46, paying $300 million upfront for all global rights to the asset. Chimagen will be eligible for an additional $550 million in development and commercial milestone payments under the agreement. CMG1A46 is a TCE that targets both CD19 and CD20 with high affinity for B cells expressing these markers and low affinity for CD3. The product is currently in Phase I clinical trials for leukemia and lymphoma in the U.S. and China. GSK aims to further develop and commercialize CMG1A46, with a focus on autoimmune diseases driven by B cells. 5.AbbVie Enters $1.5 Billion Collaboration to Develop Novel Antibody Therapies On October 31st, AbbVie and EvolveImmune Therapeutics have announced a collaboration valued at approximately $1.5 billion to develop novel antibody therapies targeting solid tumors and hematologic malignancies using EvolveImmune’s T-cell engager (TCE) platform. Under the agreement, EvolveImmune will receive $65 million in upfront payments and equity investment, with potential milestone payments of up to $1.4 billion. EvolveImmune is dedicated to developing potential "first-in-class" multifunctional biologics to address immune deficits caused by cancer in solid and hematologic tumors. Its proprietary platform is designed to provide potent, selective, and integrative T-cell co-stimulation to enhance and sustain T-cell tumor-killing activity. 6.HK inno.N Introduces New Immunotherapy Recently, South Korean pharmaceutical company HK inno.N has announced an agreement with Novacell Technology to acquire a new immunotherapy candidate. This next-generation synthetic peptide acts as an FPR2 (formyl peptide receptor 2) agonist, enhancing the body's ability to control excessive immune responses. HK inno.N aims to leverage its anti-inflammatory and cell-regeneration properties to develop treatments for various inflammatory conditions, including ophthalmic, dermatological, and respiratory diseases. This partnership is expected to help expand its immunotherapy pipeline, addressing the growing need for immune therapies in aging populations with weakened immune functions. 7.GC Biopharma Partners with Novelty Noble for Joint Research Recently, GC Biopharma has entered a joint research agreement with Novelty Noble, a Korean biotech company specializing in antibody drug development, to develop treatments for geographic atrophy (GA). GA is an advanced form of dry age-related macular degeneration (AMD) that damages retinal tissue and can lead to blindness. Under this agreement, the two parties will collaborate through all stages of development, from identifying candidate antibody-based protein therapies to preclinical, clinical trials, and eventual commercialization. The initial phase will focus on identifying target proteins involved in GA pathology and developing candidate inhibitors, followed by proof-of-concept studies. Pharmaceutical Financing Events1.Kivu Completes $92 Million Series A Financing On October 28th, Kivu Bioscience announced the completion of a $92 million Series A financing led by Novo Holdings, with participation from Gimv, Red Tree Venture Capital, HealthCap, and BioGeneration Ventures. This funding will support Kivu’s transition of multiple oncology projects into clinical stages. Kivu is focused on developing next-generation ADC therapies using its proprietary Synaffix site-specific conjugation technology, which enhances ADC stability and reduces potential side effects. Kivu’s lead candidates are in the late preclinical research stage, with the primary candidate anticipated to enter Phase I clinical trials in 2025. 2.EyePoint Completes $140 Million Financing On October 29th, EyePoint Pharmaceuticals announced the successful underwriting of over 12.72 million shares of common stock at a public offering price of $11.00 per share, with total proceeds expected to reach approximately $140 million. The financing will primarily support the clinical development of the company’s drug, Duravyu, aimed at treating wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as its early-stage pipeline programs. EyePoint is dedicated to developing and commercializing innovative therapies to improve the lives of patients with serious retinal diseases. Its proprietary bio-renewable Durasert E technology facilitates sustained intraocular drug delivery. The company’s lead candidate, Duravyu, is a sustained-release treatment targeting VEGF-mediated retinal diseases and is currently undergoing a global pivotal Phase III trial. 3.Pathos AI Completes $62 Million Series C Financing On October 29th, Pathos AI announced the completion of a $62 million Series C financing led by New Enterprise Associates (NEA), with participation from Revolution Growth. The funds will allow Pathos AI to expand its team of scientists and engineers, accelerate the development of its AI-driven drug discovery platform, and advance its clinical-stage precision oncology pipeline. Pathos AI focuses on reshaping drug development through AI and has acquired two clinical-stage precision oncology assets in the past year, including the brain-penetrant PRMT5 inhibitor P-500, with plans to initiate the next clinical trial in 2025. 4.Axonis Completes $115 Million Series A Financing On October 30th, Axonis Therapeutics announced the completion of a $115 million Series A financing led by Cormorant Asset Management and venBio Partners, with participation from Sofinnova Investments, MRL Ventures Fund, Perceptive Advisors, Lumira Ventures, and Solasta Ventures. Axonis focuses on developing novel neurotherapeutics, with this funding set to advance its lead candidate, AXN-027, through clinical proof of concept and to develop next-generation KCC2-targeted compounds. AXN-027 is an oral small-molecule drug with potential as a first-in-class treatment for epilepsy and pain. This funding will also support the development of its next-generation KCC2-targeting compounds for indications such as epilepsy, pain, psychiatric, and neurodevelopmental disorders. 5.Blue Earth Completes $76.5 Million Series A Financing On October 30th, Blue Earth Therapeutics announced the completion of a $76.5 million Series A financing led by Soleus Capital and Sands Capital Management, with additional investors including Bracco Imaging SpA, Woodline Partners, and PBM Capital. This funding will advance the company’s clinical-stage development of a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy. Blue Earth is dedicated to developing therapeutic radiopharmaceuticals for cancer patients, with a pipeline including two rhPSMA molecules: one using the beta-emitting isotope lutetium-177 (177Lu) and the other using the alpha-emitting actinium-225 (225Ac). The 177Lu-based radioligand therapy is currently in a Phase I clinical trial for prostate cancer patients. 6.Hengjing Biotechnology Secures Over 200 Million RMB in Series A/A+ Financing On October 30th, Hengjing Biotechnology has successfully completed Series A and A+ financing rounds totaling approximately 250 million RMB. The funding will be used primarily for clinical research on its pipeline products, production project construction, and daily operations. Hengjing Biotechnology specializes in the industrialization of biologic drugs, focusing on biosimilars and innovative biologics like insulin and GLP-1 receptor agonists. The company has established a proprietary prokaryotic cell gene engineering platform for producing recombinant proteins and has implemented an end-to-end layout, from active pharmaceutical ingredient (API) development to contract development and manufacturing organization (CDMO) services, product development, and production. 7.CureGene Pharmaceutical Completes Series B+ Financing On October 31st, CureGene Pharmaceutical has announced the completion of its Series B+ financing led by Guoxin Innovation (China Bidding), with participation from aeonmed, INFINITY EQUITY MANAGEMENT COMPANY, and OCEANIC GROUP INVESTMENT LIMITED. This financing will accelerate the clinical development of CureGene’s core cardiovascular product, CG-0255. Founded in 2018, CureGene specializes in the development of small molecule and nucleic acid drugs. CG-0255, a new-generation antiplatelet drug targeting the P2Y12 receptor, is currently advancing through regulatory clinical trials in the United States. Additionally, CureGene has a pipeline that includes broad-spectrum antiviral drugs and treatments aimed at functional cures for chronic hepatitis B. 8.Leal Therapeutics Completes $45 Million Financing On October 31st, Leal Therapeutics announced the completion of a $45 million financing round led by Newpath Partners, with additional investment from Orbidden, Euclidean Capital, PhiFund, Chugai Venture Fund, and Alexandria Venture Investments. The funds will support the company’s development pipeline of antisense oligonucleotides (ASO) and small molecules for central nervous system (CNS) disorders. Leal Therapeutics is developing innovative therapies for CNS disorders, with key programs including LTX-002, an ASO therapy for amyotrophic lateral sclerosis (ALS), and LTX-001, a small molecule for schizophrenia patients. The company plans to submit IND applications for LTX-002 and LTX-001 by the end of 2024 and to initiate the first human trials in early 2025. 9.Eupraxia Completes CAD $44.5 Million Financing On October 31st, Eupraxia Pharmaceuticals announced the completion of a CAD $44.5 million private placement financing to support the clinical trials of its investigational product EP-104 GI and initiate research for new candidates. Eupraxia is a clinical-stage biotechnology company utilizing its proprietary DiffuSphere technology to optimize drug delivery for unmet medical needs. EP-104 GI, a potential treatment for eosinophilic esophagitis, is currently in a Phase Ib/IIa trial delivered via esophageal wall injection. 10.Evommune Completes $115 Million Series C Financing On November 1st, Evommune announced the successful completion of a $115 million Series C financing led by RA Capital Management and Sectoral Asset Management, with additional participation from B Capital, Marshall Wace, Avego Bioscience Capital, Longwood Fund, and RTW Investments. The funds will support the clinical development of Evommune’s MRGPRX2 inhibitor EVO756 and IL-18-targeted fusion protein therapy EVO301. EVO756 is an oral, potent, and highly selective MRGPRX2 small molecule antagonist, and EVO301 is a long-acting fusion protein injection therapy that binds to serum albumin. The company plans to release data from multiple Phase II trials for these therapies in chronic urticaria and atopic dermatitis patients by 2025 and 2026. 11.Celaid Completes JPY 140 Million Financing Recently, Celaid Therapeutics announced the receipt of JPY 140 million from KUC1 Investment Limited Partnership and Techno Science, with additional investment from existing investor Techno Science, bringing the total Series A funding to JPY 1.1 billion (excluding grants). The funding is expected to accelerate Celaid’s pipeline development and platform activities. Celaid is a hematopoietic stem cell (HSC) startup with proprietary technology for selective ex vivo HSC expansion, aiming to deliver next-generation cell and gene therapies for hematologic diseases, ex vivo HSC gene therapy for genetic disorders, and angiogenesis for ischemic conditions. For more information on the progress of pharmaceutical funding transactions, please consult the Synapse database.

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