Athersys, Inc. (NASDAQ: ATHX) is having an overwhelmingly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced that a Phase 3 trial design received positive views from the EMA. As a result, investor excitement ensued, leading to gains and prompting our partners at Trade Ideas to alert us to the movement. At the moment (8:55), ATHX is trading at $1.70 per share after a gain of $0.23 per share or 15.65% thus far today.
ATHX Gains On Phase 3 Study News
As mentioned above, Athersys is having an incredibly strong time in the pre-market this morning after announcing that the design of its Phase 3 clinical study, using MultiStem® cell therapy to treat ischemic stroke received a Final Scientific Advice positive opinion from the European Medicines Agency. This means that should the trial be successful, the EMA believes that the success would warrant approval for commercialization in Europe. The potential treatment has also received positive views in both the United States and Japanese markets.
As a result, ATHX could bring the treatment to three major pharmaceutical markets relatively soon. In a statement, Dr. Gil Van Bokkelen, Chairman and CEO at ATHX, had the following to offer…
“We are excited about receiving the positive opinion on our pivotal, registrational stroke study, MASTERS-2, and we thank the EMA for its continued support of our efforts to develop an important new treatment option for patients in this area of significant unmet medical need… Recent publications and presentations reinforce years of promising work and continue to illustrate how we might be able to improve outcomes and substantially extend the treatment window to 36 hours for stroke patients with MultiStem, beyond the narrow treatment window for tPA and mechanical reperfusion that exist today. The publications also provide further evidence of the important biological mechanisms that MultiStem cell therapy may convey to help patients recover from a debilitating stroke event. Stroke remains a leading cause of serious disability and represents a substantial burden on patients, families and healthcare systems around the world, and we are committed to transforming medical care in this important area.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be watching ATHX incredibly closely. In particular, we’re interested in following the Phase 3 study and excited for the results. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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