Progenics Pharmaceuticals, Inc. announced positive top line results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL™ (18F-DCFPyL) in men with biochemical recurrence of prostate cancer. PyL is the Company’s PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer. The Phase 3 CONDOR trial is a prospective, multi-center, open label pivotal trial in which 208 patients with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities (that is Axumin, Choline PET, CT/MR and/or bone scan) were dosed and imaged with PyL at 14 sites in the United States and Canada. The CONDOR trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value, defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT and a composite truth standard comprised of histopathology, conventional imaging and/or changes in PSA levels following radiation therapy. Safety results showed PyL was well tolerated, consistent with the Phase 2 OSPREY trial results. There was one serious adverse event of hypersensitivity reported in one patient as related to the study drug. The most frequent adverse event reported was headache, which was reported in four patients (1.9% of the trial population). Additional results from the CONDOR trial are expected to be presented at an upcoming medical meeting.