Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) is having an incredibly rough start to the trading session this morning, and for good reason. The comapny announced top-line data from a Phase 3 clinical trial, missing the market. Of course, the news upset investors who are sending the stock tumbling down. Today, we’ll talk about:
- The clinical data;
- what we’re seeing from PGNX as a result; and
- what we’ll be watching for ahead.
PGNX Announces Clinical Dta
As mentioned above, Progenics Pharmaceuticals is having a rough start to the trading session this morning after announcing clinical data. In a press release issued early this morning, the company reported top line data from the Phase 3 clinical study looking into candidate 1404. The candidate is a prostate specific membrane antigen (PSMA)-targeted small molecule SPECT/CT imaging agent designed for the visualization of prostate cancer.
While the primary endpoint of the study, the detection of clinically meaningful prostate cancer with specifity range among various readers, the co-primary endpoint was missed. Unfortunately, seensitivity wasn’t quite what the company wanted to see. In a statement, Mark Baker, CEO at PGNX, had the following to offer:
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.
We believe that PSMA-targeted imaging holds tremendous promise to improve the detection, staging and monitoring of prostate cancer. These results do not impact our view of the PyL PET imaging agent in patients with recurrent or metastatic prostate cancer as we head into our Phase 2/3 data readout next quarter, and we remain on track to initiate our second Phase 3 study by year-end. Our oncology therapeutic programs continue to move forward, including the ongoing commercial launch of AZEDRA® for the treatment of pheochromocytoma or paraganglioma. In addition, we anticipate finalizing our clinical development plan with the U.S. FDA for 1095 in metastatic castration-resistant prostate cancer (mCRPC) in the fourth quarter and expect our partner Bayer to initiate a Phase 1 study of PSMA-TTC in patients with mCRPC by year end 2018.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news causes moves. In the case of Progenics, the news proved to be negative. Sure, the primary endpoint was met, but without meeting the secondary endpoint, the study was a failure and the company is back to the drawing board. So, it comes as no surprise that upset investors are sending the stock tumbling down. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:41), PGNX is trading at $5.86 per share after a loss of $1.44 per share or 19.73% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on PGNX. In particular, we’re interested in following the story surrounding the company’s plans with the asset following the study failure. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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