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Who We Are - SOFIE We are dedicated to improving patient outcomes by developing, supplying and delivering molecular diagnostics and therapeutics (theranostics)
SOFIE Biosciences Announces First Patient Dosed in [18F]FAPI-74 Phase 3 . . . SOFIE Biosciences today announced that the first patient has been dosed in its Phase 3 clinical trial evaluating [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein (FAP), as a novel diagnostic for patients with Pancreatic Ductal Adenocarcinoma
SOFIE drives U. S. manufacture of [18F]FAPI-74 - SOFIE Seven SOFIE radiopharmacies now produce the FAP-targeting radiopharmaceutical, as SOFIE launches Phase 3 clinical trials and support of Pharma and Academic groups Map shows planned [18F]FAPI-74 U S Coverage for 2026 Kansas City, MO, and Houston, TX, are the latest SOFIE radiopharmacies cleared to manufacture [18F]FAPI-74, bringing the total number of sites to seven The other locations
Network - SOFIE SOFIE has built a high-capacity PET radiopharmaceutical network capable of delivering large volumes of products to as many patients as possible Our product lines include FDG, Pylarify, Neuraceq, and other clinical trial products
SOFIE activates FAPI-GO, first [18F]FAPI-74 Phase 3 trial - SOFIE Another defining moment for SOFIE Biosciences! Last Friday, November 14, 2025, FAPI-GO, SOFIE’s FAPI-74 Phase 3 study in gastroesophageal cancers, officially went live! The first site, a collaboration with Helios Clinical Research and RadNet, has been activated and is ready to enroll patients SOFIE plans to activate 18 total sites across the country over the next
SOFIE’s Phase 2 FAPI Study Outcomes Showcased at ASCO GI 2026 - SOFIE Results from SOFIE’s Phase 2 diagnostic study on [18 F]FAPI-74 PET were presented to the oncological community at the esteemed ASCO Gastrointestinal (GI) Cancers Symposium held in San Francisco January 8-10, 2026 The multi-center trial showed that [18 F]FAPI-74 PET detects FAP expression and presence of disease in cancers of the gastrointestinal tract, with high positive predictive values
SOFIE Biosciences Prepares Launch of Two [18F]FAPI-74 Phase 3 Studies . . . It is fantastic to see that [18 F]FAPI-74 is now moving into a pivotal phase 3 study ” STUDY DESIGN AND NEXT STEPS The EOP2 meeting focused on discussing SOFIE’s Phase 2 data and resulted in alignment with the FDA on the two Phase 3 studies’ design and endpoints
SOFIE and GE HealthCare Enter Licensing Agreement to Develop FAP PET . . . A global licensing agreement has been signed for the development and commercialization of SOFIE’s two investigational Gallium-68 and Fluorine-18 Fibroblast Activation Protein Inhibitors (FAPI) radiopharmaceutical diagnostics - [68Ga]FAPI-46 and outside-U S rights for [18F]FAPI-74 FAP is highly expressed in cancer associated fibroblasts (CAF), which supports the growth and spread of