Athersys (ATHX) Stock Gaining Big On FDA News

Athersys, Inc. (NASDAQ: ATHX)

Athersys is having an incredible day in the market today, and for good reason. Early this morning, the company released positive news that it received from the United States Food and Drug Administration. Today, we’ll talk about the news, what we’re seeing from the stock as a result, and what we can expect to see from ATHX ahead. So, let’s get right to it…

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ATHX Moves One Step Closer To MultiStem Approval In Ischemic Stroke

As mentioned above, Athersys is having a strong day in the market today after announcing solid news from the United States FDA. According to the announcement, the company has received agreement from the FDA under a Special Protocol Assessment for the design and planned analysis of a Phase 3 clinical trial.

ATHX is working toward the approval of MultiStem cell therapy as a treatment of ischemic stroke. As a result of the agreement, the company now knows that it will be able to use data from a previous study to reach for approval. That study is known as the MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2, also known as MASTERS-2. Combining the data from this study with other clinical data will provide the foundation of the regulatory package to be submitted for marketing approval. In a statement, Dr. Gil Van Bokkelen, Chairman and CEO at ATHX, had the following to offer:

This is a major accomplishment for Athersys, as it clearly defines the development and regulatory pathway for the approval of MultiStem cell therapy for the treatment of ischemic stroke… We would like to thank the FDA for its engagement and guidance in this process, and the clinical investigators who have been critical to our development of this potential treatment for stroke.

The SPA is important in clarifying and de-risking an accelerated development pathway for us because it means that the successful completion of the MASTERS-2 trial, together with other available clinical data, could enable us to apply for marketing approval in the United States. With this goal now achieved, we will continue the process of engagement with the FDA, European and Canadian regulators, as well as the many sites that have expressed an interest in participating in the study, to complete other necessary activities prior to trial initiation. We intend to be prepared to launch the trial in 2017 and will update our stockholders as we move forward with these plans.”

How The Stock Reacted To The News

One of the first things we learn as investors is that the news moves the market. Any time positive news is released with regard to a publicly-traded company, we can expect to see gains. Negative news will lead to losses. In this particular case, the news was overwhelmingly positive. After all, ATHX is now one step closer to MultiStem approval in ischemic stroke. As a result, we’re seeing strong gains in the value of the stock today. Currently (11:43), the stock is trading at $2.08 per share after a gain of $0.12 per share (6.12%) thus far today.

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What We Can Expect To See Moving Forward

Moving forward, I have a relatively bullish opinion with regard to what we can expect to see from Athersys. At the end of the day, the company has done an incredible job when it comes to pushing MultiStem through the process. Now, it seems like approval for the therapy as a treatment for ischemic stroke may be just around the corner. All in all, things look great. However, any time investments are hinged on clinical trials and regulatory approval, there is going to be added risk. So, if you decide to get involved, keep the risks in mind.

[Image Courtesy of Wikimedia]

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