18F-Fluoromisonidazole

Prostate cancer and Alzheimer’s disease imaging programs position the Company for FDA submissions in 2027 across two of the fastest-growing segments in molecular imaging BEDMINSTER, N.J., Sept. 15, 2026 (GLOBE NEWSWIRE) -- Juniper Biosciences today unveiled two previously undisclosed radiopharmaceutical programs: JBS-002, a Ga-68 based cold kit for prostate cancer imaging, and JBS-004, a fluorine-18 labeled diagnostic imaging agent for Alzheimer’s disease. Both assets have been advanced privately through development and are disclosed today at the registrational stage, with registration batch manufacturing scheduled for the fourth quarter of 2026 in support of planned submissions to the U.S. Food and Drug Administration (FDA) in 2027. The Company is disclosing both assets now that they stand at the threshold of regulatory submission, revealing a deep late-stage diagnostic portfolio — two registrational programs addressing large, established imaging markets. JBS-002: A Ga-68 based Kit for Precision Prostate Cancer Imaging Prostate-specific membrane antigen (PSMA) is a transmembrane protein expressed at low levels in normal prostate tissue but dramatically overexpressed on the surface of prostate cancer cells, including in metastatic and hormone-resistant disease. JBS-002 is an investigational PET imaging agent that binds directly to PSMA-expressing lesions and renders them visible on a whole-body scan. PSMA PET imaging is now established in clinical practice for staging men with high-risk disease before definitive treatment and for localizing the site of recurrence in patients with rising PSA after surgery or radiation, findings that frequently change the intended course of therapy. PSMA PET has become standard of care, and the U.S. market is now estimated at approximately $1.8 billion annually. Growth continues on two fronts: expanding NCCN-guideline use across the disease course, and the rapid adoption of PSMA-targeted radioligand therapy, which depends on PSMA imaging to select and monitor patients. JBS-004: An F-18 Diagnostic Imaging Agent for Alzheimer’s Disease JBS-004 is an investigational fluorine-18 labeled PET imaging agent designed to provide a non-invasive visual assessment of Alzheimer’s disease pathology in adult patients being evaluated for cognitive impairment. Historically, a definitive determination of Alzheimer’s pathology could be made only at autopsy, leaving clinicians to diagnose by exclusion. Molecular imaging changes that calculus by making the underlying pathology directly observable in living patients, supporting earlier diagnostic certainty, reducing misdiagnosis in a population where symptoms overlap with numerous other conditions, and identifying which patients are appropriate candidates for the new generation of disease-modifying Alzheimer’s therapies—treatments that require confirmation of pathology before they can be prescribed. The commercial context for this imaging has changed fundamentally in recent years. The arrival of therapies converted Alzheimer’s PET from a research tool into a required gateway to treatment. Scan volumes have grown sharply against a small field of approved agents. An Expanding Late-Stage Portfolio With JBS-002 and JBS-004 both entering registration batch manufacturing in the fourth quarter of 2026, Juniper Biosciences has two late-stage diagnostic assets advancing in parallel toward FDA submission in 2027, alongside JBS-003, the Company’s previously disclosed Phase III program in HPV-positive oropharyngeal cancer. Three programs now sit in registrational or Phase III development across prostate cancer, Alzheimer’s disease, and head and neck cancer—a portfolio built by a team with deep operating experience in radiochemistry and complex manufacturing. “Reaching registration batch manufacturing on two programs in the same quarter is a defining moment for a company of our size,” said Alex Agnoletto, Chief Executive Officer of Juniper Biosciences. “JBS-002 and JBS-004 serve different physicians and different diseases, but they reflect the same conviction: better decisions require better information. Together with JBS-003, they give us three programs in registrational or Phase III development and a clear path to becoming a commercial-stage company in the near future” Commercialization Juniper Biosciences intends to commercialize JBS-002 and JBS-004 in the United States if the programs receive marketing approval from the FDA. The Company is advancing both agents through registration with the objective of transitioning from a development-stage organization to a commercial-stage one, and preparatory work to support a potential launch of each program is proceeding in parallel with the regulatory work described above. JBS-002 and JBS-004 are investigational agents. Neither has been approved by the FDA or any other regulatory authority, and the safety and effectiveness of neither agent has been established. Any commercial launch is contingent on FDA approval, and neither the outcome nor the timing of the regulatory review process can be assured. About Juniper Biosciences Juniper Biosciences is a cutting-edge radiopharmaceutical drug development company, with a mission to improve access to novel therapeutic and diagnostic radiopharmaceutical agents. The founding team is comprised of distinguished industry members with proven track records and deep expertise in radiochemistry and complex manufacturing. CONTACT: For further information, please contact: Alex Agnoletto, CEO Alex.Agnoletto@juniperbiosci.com