Athersys, Inc. (NASDAQ:ATHX)
Athersys, Inc. (NASDAQ:ATHX) stock rose to $1.70 before closing at $1.56 in Monday’s trading. ATHX stock had closed at $1.46 on Friday then gapped up to open at $1.69 before settling back at the closing price.
The market was reacting to the company’s press release announcing that the design of its Phase 3 clinical study treating ischemic stroke with its proprietary MultiStem® cell therapy product (the “MASTERS-2” study) has received a Final Scientific Advice positive opinion from the European Medicines Agency (“EMA”). This represents EMA’s opinion that, upon success, the study should be sufficient to warrant approval for commercialization, which is in line with the U.S. Special Protocol Assessment and Fast Track Designation.
This means that, in the USA, Japan, and the EU, Athersys and its existing and future partners have a clearer development path to commercialization for MultiStem therapy for moderate to severe ischemic stroke. That clarity will allow Athersys, Inc. (NASDAQ:ATHX) to facilitate planning and operations and remove regulatory uncertainty from the development program. Additionally, the stroke program is positioned for priority review and accelerated approval, shortening the time from successful study results to commercialization. As a result, with successful study outcome and registration, Athersys’ MultiStem cell therapy could represent the first major advancement in decades for the treatment of acute stroke.
Athersys, Inc. (NASDAQ:ATHX) shares have been extremely volatile. In April ATHX stock hit $2.00 then later fell back to $1.40. That volatility is reflected in ATHX performance. YTD the stock price is up almost 2%, but the stock is down over 27% for the year. For the quarter, ATHX stock is up almost 10% but is down over 10% for the month. Analysts have given ATHX stock a consensus price target of $7.00 but the shares are still over 30% off their 52-week high of just $2.30.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
Don’t miss out! Stay informed on $ATHX and receive breaking news on other hot stocks by signing up for our free newsletter!
About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.