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LONDON, UK / ACCESSWIRE / August 9, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Athersys, Inc. (NASDAQ: ATHX), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=ATHX. The Company announced on August 07, 2017, that the Phase-3 clinical study treating ischemic stroke with its proprietary MultiStem cell therapy product has received a Final Scientific Advice positive opinion from the European Medicines Agency. In Japan, Athersys' partner, HEALIOS KK is conducting the TREASURE study, evaluating MultiStem therapy for ischemic stroke, and has received a priority review designation under Sakigake from Japan's Pharmaceutical and Medical Devices agency. The results from the TREASURE study, if needed, are acceptable for supporting the applications for registration, along with the result from the MASTER-2 study, both in the US and Europe. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected Spark Therapeutics, Inc. (NASDAQ: ONCE) for due-diligence and potential coverage as the Company announced on August 02, 2017, its financial results for Q2 2017. Tune in to our site to register for a free membership, and be among the early birds that get our report on Spark Therapeutics when we publish it.

At Pro-TD, we make it our mission to bring you news that matter about the stock you follow. Today, our research desk covers a blog story on ATHX; also brushing on ONCE. Go directly to your stock of interest and access today's free coverage at:

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The FDA Agreement

On September 28, 2016, Athersys announced that it received agreement from the US FDA under a Special Protocol Assessment for the design and planned analysis of a Phase-3 clinical trial of its MultiStem cell therapy product. The results from the Phase-3 trial, named MASTER-2 (MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2), along with other available clinical data, would act as a foundation of the regulatory package to be submitted for regulatory approval.

The Announcement

Post this announcement, in the three major pharmaceutical markets, Athersys and its existing and future partners have clarity with respect to the development path to commercialization for MultiStem therapy for moderate to severe ischemic stroke, facilitating planning and operations and removing regulatory uncertainty from the development program. In addition, the stroke program is positioned for priority review and accelerated approval, shortening the time from successful study results to commercialization. As a result, post the successful study outcome and registration; the therapy could represent the first major advancement in decades for the treatment of acute stroke, outside of limited current treatment options.

Ischemic Stroke

According to Athersys, there are currently over 17 million people that suffer a stroke globally, and, on average, someone in the US has a stroke every 40 seconds. Ischemic stroke represents the most common form of stroke and is caused by a blockage of blood flow in the brain that cuts off the supply of oxygen and nutrients and can result in long-term or permanent disability due to neurological damage. The long-term costs of strokes are substantial, demanding extended hospitalization, extended physical therapy or rehabilitation, where many require long-term institutional or family care.

MASTERS-2 Trial

The MASTERS-2 clinical trial is a randomized, double-blind, placebo-controlled clinical trial designed to enroll patients in North America and Europe who have suffered moderate to moderate-severe ischemic stroke. The enrolled subjects received either a single intravenous dose of MultiStem cell therapy, administered within 18-36 hours of the occurrence of the stroke, in addition to the standard of care. The primary end-point of the study evaluated disability using modified Ranking Scale (mRS) scores at three month, comparing the distribution between the two groups. The mRS shift analysis considers disability across the full spectrum, enabling recognition of large and small improvements in disability and differences in mortality and other serious outcomes, among strokes of different severities. The study will also assess Excellent Outcome (mRS ?1, NIHSS ?1, and Barthel Index ?95) at three months and one year as key secondary end-points.

Last Close Stock Review

On Tuesday, August 08, 2017, the stock closed the trading session at $1.52, slipping 2.56% from its previous closing price of $1.56. A total volume of 967.40 thousand shares have exchanged hands, which was higher than the 3-month average volume of 601.54 thousand shares. Athersys' stock price soared 9.35% in the last three months and 31.03% in the past six months. At Tuesday's closing price, the stock's net capitalization stands at $168.02 million.

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