Progenics Pharmaceuticals Inc. (NASDAQ: PGNX) shares dropped sharply on Thursday after the company announced late-stage results from its prostate cancer study. Specifically, the firm announced top-line data from its Phase 3 study of 1404, its prostate specific membrane antigen-targeted small molecule SPECT/CT imaging agent that is designed to visualize prostate cancer.
The Phase 3 trial evaluated the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and sensitivity to identify patients with clinically significant disease. The study dosed 471 patients in the United States and Canada with low-grade prostate cancer.
In the study, 1404 detected clinically meaningful prostate cancer with specificity ranging among the three readers from 71% to 75% (95% confidence interval CI of 64% to 80%). The co-primary endpoint of sensitivity was not met and ranged among the three readers from 47% to 51% (95% CI of 41% to 56%).
Mark Baker, CEO of Progenics, commented:
These top line Phase 3 results of 1404 are inconsistent with the prior Phase 2 data, which showed significantly higher sensitivity rates. We are currently conducting a thorough analysis of the full data set to understand the factors that may have contributed to this outcome and determine the appropriate development path for this novel agent in patients with low-grade prostate cancer. We plan to complete this review in the next quarter.
Shares of Progenics were last seen down about 18.5% at $5.95, with a consensus analyst price target of $15.00 and a 52-week trading range of $5.01 to $9.42.