Progenics Pharmaceuticals, Inc. announced the results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyLTM in men with biochemical recurrence of prostate cancer. PyL is the company’s PSMA-targeted small molecule positron emission tomography 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, including 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 trial achieved its primary endpoint, with a correct localization rate 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 PyL and a composite truth standard comprised of histopathology, conventional imaging and/or a = 50% decline in PSA levels following radiation therapy. Median CLR in patients with baseline PSA <0.5 ng/mL, 0.5 to <1.0 ng/mL, and 1.0 to <2.0 ng/mL were 73.3%, 75.0%, and 83.3%, respectively, which are promising results in a patient population with non-informative baseline findings based on available approved imaging modalities. 63.9% of patients in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial. The most frequent changes to treatment management plans due to the PyL results included salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage local therapy, and planned treatment to observation. Consistent with the Phase 2 OSPREY trial results, safety results showed that PyL was well tolerated. There was one serious adverse event of hypersensitivity reported as related to the study drug in a patient with significant allergic history.