Athersys, Inc. (NASDAQ:ATHX) investors cheer the announcement that the stem cell company received Special Protocol Assessment (SPA) from the FDA for the design and planned analysis of a Phase 3 clinical trial of Athersys’ novel MultiStem® cell therapy product for the treatment of ischemic stroke.
Athersys shares reacted to the news, rising nearly 15% in pre-market trading.
The SPA provides agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys’ planned Phase 3 study are acceptable to support a regulatory submission for approval of the MultiStem product for treating ischemic stroke patients. The results from the Phase 3 trial entitled, “MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2” (MASTERS-2), together with other available clinical data, would provide the foundation of the regulatory package to be submitted for marketing approval.
“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,” stated Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys. “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,” continued Dr. Van Bokkelen. “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.” (Original Source)
On the ratings front, Maxim analyst Jason Kolbert reiterated a Buy rating on ATHX, with a price target of $10, in a report issued on September 12. The current price target implies an upside of 410.2% from current levels. According to TipRanks.com, Kolbert has a yearly average return of -15.9%, a 28.5% success rate, and is ranked #4074 out of 4185 analysts.
Athersys, Inc. is a biopharmaceutical company which engages in the discovery and development of therapies designed to extend and enhance the quality of human life. Its product development program, MultiStem, a proprietary off the shelf stem cell product used to treat indications in the inflammatory & immune, neurological and cardiovascular disease areas.