Phase 3 Study Enrollment Continues Post Interim Analysis; Pipeline Could Drive Upside
Phase 3 Study Enrollment Continues Post Interim Analysis; Pipeline Could Drive Upside
Phase 3 Study Enrollment Continues Post Interim Analysis; Pipeline Could Drive Upside
Phase 3 Study Enrollment Continues Post Interim Analysis; Pipeline Could Drive Upside
Phase 3 Study Enrollment Continues Post Interim Analysis; Pipeline Could Drive Upside
Phase 3 Study Enrollment Continues Post Interim Analysis; Pipeline Could Drive Upside
After the close, Progenics announced that its independent Data Monitoring Committee (DMC) completed an interim analysis of its ongoing Phase 3 trial for 1404 – a PSMA targeted imaging agent – recommending that the trial continue enrolling patients. We believe this news is positive as ~190 of a planned 450 patients have enrolled in this pivotal study, with completion expected by the end of 2017. In addition, a modification to the study protocol has been agreed to by the FDA to allow patients with low to very low grade prostate cancer to participate in this trial; we believe this change could accelerate patient enrollment of the Phase 3 clinical trial.
Overall, we continue to like the risk/reward profile with the Co.’s pipeline. Heading into 2017, we believe Progenics should benefit from improving visibility on its pipeline, with a top-line data readout from its ongoing 68-patient, Phase 2b trial with Azedra (a radiotherapeutic for the treatment of pheochromocytoma – a rare form of cancer in the adrenal glands). If results are positive, we expect the Co. to file an NDA in 1H17. The FDA has assigned Fast Track Status to Azedra, which suggests an expedited review is possible.
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