Endocyte, Inc. (NASDAQ: ECYT) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced a regulatory update that excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from ECYT stock as a result; and
- what we’ll be watching for ahead.
ECYT Announces Regulatory Update
As mentioned above, Endocyte is having an incredibly strong start to the trading session this morning after announcing a regulatory update. In a press release issued early this morning, the company said that following a meeting with the United States Food and Drgu Administration (FDA), it has been determined that rPFS is an appropriate efficacy endpoint in the ongoing phase 3 VISION trial. Therefore, should the trial meet the endpoint, the company may move forward with the submission of a New Drug Application (NDA).
The VISION trial is currently assessing 177Lu-PSMA-617 as a treatment for metastatic castration-resistant prostate cancer. The Phase 3 VISION trial is an ongoing clinical trial assessing the efficacy, safety and tolerability of the treatment in hopes of an NDA submission following the data readout. In a statement, Mike Sherman, President and CEO at ECYT, had the following to offer:
We are very pleased with the FDA’s support of the rPFS endpoint as the basis for a submission for full approval of 177Lu-PSMA-617. This change provides an opportunity to obtain a full approval sooner than we previously anticipated and highlights the Agency’s commitment to addressing the urgent need for a new mechanism of action to treat mCRPC… Under the updated protocol, we now expect the analysis of rPFS for potential full approval to occur before the end of 2019. We also retained the final, fully powered OS analysis, which is expected to occur near the end of 2020. This provides two potential paths for approval and preserves a robust OS analysis to support a potential label.
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 leads to moves. In the case of Endocyte, the news proved to be overwhelmingly positive. After all, we now know that should the Phase 3 VISION trial meet its primary endpoint, a New Drug Application is on the horizons. So, it comes as no surprise to see that excited investors are sending the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:21), ECYT is trading at $17.84 per share after a gain of $0.88 per share or 5.16% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ECYT. In particular, we’re interested in following the story surrounding Phase 3 VISION trial as the trial could lead to an NDA. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!