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Athersys (ATHX) Stock Rallies as William Blair Initiates Coverage
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Shares of Athersys, Inc. surged significantly in the post market trading on Mar 28 after research firm William Blair initiated a coverage on the stock with an outperform rating.
Share Price Movement
Shares of the Athersys have performed better than the Zacks classified Medical-Biomedical/Genetics industry in the last one month. Specifically, shares have gained 12.4% during this time period as compared to the industry’s decline of 3.2%.
Pipeline Projects
Headquartered in Cleveland, OH, Athersys primarily focuses on regenerative medicine arena. The company’s patented and proprietary allogeneic stem cell product, Multistem cell therapy is currently being evaluated for various indications in the neurological, cardiovascular, inflammatory and immune disorders, and certain pulmonary conditions. The product is in late-stage clinical development at present.
Athersys has advanced six MultiStem programs to clinical trials. The lead clinical program is for ischemic stroke. The company has completed a phase II study of MultiStem treatment of patients suffering from moderate to severe ischemic stroke. In Sep 2016, the company reached an agreement with the FDA under a Special Protocol Assessment (SPA) for the design and planned analysis of its phase III trial, MASTERS-2, for ischemic stroke.
The SPA revealed that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys’ planned phase III study are acceptable to support a regulatory submission for the approval of the MultiStem product for treating ischemic stroke patients. The study will be initiated later in 2017. The company expects results from the phase III trial, MASTERS-2, (assuming successful) along with other available clinical data should enable the company to submit the same for marketing approval.
Also, Healios, Athersyx’s partner in Japan will evaluate MultiStem cell therapy for the treatment of ischemic stroke in the TREASURE trial. This study will be completed in the second half of 2018.
The ischemic stroke market holds great potential. Approximately 800,000 individuals in the U.S. suffer from a stroke every year with the global tally being 16.9 million. Approximately 85% to 90% of these strokes are ischemic while the remaining 10% to 15% are hemorrhagic. As per the company, the only FDA-approved drug currently available for ischemic stroke is the anti-clotting factor, tPA.
The analysis form various conducted studies show that treatment with MultiStem (24 to 36 hours post-stroke) resulted in better recovery in comparison to placebo. It was also observed that the effect is more pronounced for subjects receiving MultiStem earlier than 36 hours post-stroke.
Meanwhile, the company is also evaluating MultiStem cell therapy in patients suffering from an Acute Myocardial Infarction (AMI) in an ongoing phase II study. Athersys is currently enrolling patients in a phase II clinical study which evaluates the safety and efficacy of MultiStem treatment in subjects who have a non-ST elevated myocardial infarction. Athersys initiated a clinical study for the treatment of Acute Respiratory Distress Syndrome (ARDS) in the U.K. and the U.S.
In addition, the company also completed a phase I study to evaluate the safety, efficacy and potential for MultiStem cell therapy to prevent or reduce graft-versus-host disease (GvHD) and other complications, and to provide supportive care to patients undergoing a hematopoietic stem cell transplant to treat leukemia or certain other blood borne cancers. We note that the company obtained orphan drug designation by the FDA and the EMA for MultiStem treatment in the prevention of GvHD.
The MultiStem product was granted Fast Track designation by the FDA in 2015 for prophylaxis therapy against GvHD following hematopoietic cell transplantation. The company’s registration study design also received a positive opinion from the EMA through the Protocol Assessment/Scientific Advice procedure. Thereafter, in Dec 2015, the proposed registration study received Special Protocol Assessment designation from the FDA. This in turn indicates that the trial is adequately designed to support a biologics license application (BLA) submission for registration if it is successful.
Athersys has technology licensing arrangements with companies like Bristol-Myers Squibb (BMY - Free Report) . These collaborations provide the company with the required capital to advance its pipeline further.
Our Take
We expect the company to further advance its lead program in ischemic stroke in 2017. The successful development of this program will be a significant boost for the company given the high potential of the market.
Zacks Rank & Other Stocks to Consider
Athersys currently carries a Zacks Rank #2 (Buy).
Other favorably placed stocks in the health care sector include Heska Corporation and Retrophin, Inc. . Both the stocks flaunt a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive earnings surprise in all the four trailing quarters with an average beat of 291.54%. Its share price increased 33.8% year to date.
Retrophin’s loss estimates narrowed from 85 cents 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
Want to learn more about the biotech market and what's hot now? Check out our recent podcast with an immunotherapy expert for additional information:
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>
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Athersys (ATHX) Stock Rallies as William Blair Initiates Coverage
Shares of Athersys, Inc. surged significantly in the post market trading on Mar 28 after research firm William Blair initiated a coverage on the stock with an outperform rating.
Share Price Movement
Shares of the Athersys have performed better than the Zacks classified Medical-Biomedical/Genetics industry in the last one month. Specifically, shares have gained 12.4% during this time period as compared to the industry’s decline of 3.2%.
Pipeline Projects
Headquartered in Cleveland, OH, Athersys primarily focuses on regenerative medicine arena. The company’s patented and proprietary allogeneic stem cell product, Multistem cell therapy is currently being evaluated for various indications in the neurological, cardiovascular, inflammatory and immune disorders, and certain pulmonary conditions. The product is in late-stage clinical development at present.
Athersys has advanced six MultiStem programs to clinical trials. The lead clinical program is for ischemic stroke. The company has completed a phase II study of MultiStem treatment of patients suffering from moderate to severe ischemic stroke. In Sep 2016, the company reached an agreement with the FDA under a Special Protocol Assessment (SPA) for the design and planned analysis of its phase III trial, MASTERS-2, for ischemic stroke.
The SPA revealed that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys’ planned phase III study are acceptable to support a regulatory submission for the approval of the MultiStem product for treating ischemic stroke patients. The study will be initiated later in 2017. The company expects results from the phase III trial, MASTERS-2, (assuming successful) along with other available clinical data should enable the company to submit the same for marketing approval.
Also, Healios, Athersyx’s partner in Japan will evaluate MultiStem cell therapy for the treatment of ischemic stroke in the TREASURE trial. This study will be completed in the second half of 2018.
The ischemic stroke market holds great potential. Approximately 800,000 individuals in the U.S. suffer from a stroke every year with the global tally being 16.9 million. Approximately 85% to 90% of these strokes are ischemic while the remaining 10% to 15% are hemorrhagic. As per the company, the only FDA-approved drug currently available for ischemic stroke is the anti-clotting factor, tPA.
The analysis form various conducted studies show that treatment with MultiStem (24 to 36 hours post-stroke) resulted in better recovery in comparison to placebo. It was also observed that the effect is more pronounced for subjects receiving MultiStem earlier than 36 hours post-stroke.
Meanwhile, the company is also evaluating MultiStem cell therapy in patients suffering from an Acute Myocardial Infarction (AMI) in an ongoing phase II study. Athersys is currently enrolling patients in a phase II clinical study which evaluates the safety and efficacy of MultiStem treatment in subjects who have a non-ST elevated myocardial infarction. Athersys initiated a clinical study for the treatment of Acute Respiratory Distress Syndrome (ARDS) in the U.K. and the U.S.
In addition, the company also completed a phase I study to evaluate the safety, efficacy and potential for MultiStem cell therapy to prevent or reduce graft-versus-host disease (GvHD) and other complications, and to provide supportive care to patients undergoing a hematopoietic stem cell transplant to treat leukemia or certain other blood borne cancers. We note that the company obtained orphan drug designation by the FDA and the EMA for MultiStem treatment in the prevention of GvHD.
The MultiStem product was granted Fast Track designation by the FDA in 2015 for prophylaxis therapy against GvHD following hematopoietic cell transplantation. The company’s registration study design also received a positive opinion from the EMA through the Protocol Assessment/Scientific Advice procedure. Thereafter, in Dec 2015, the proposed registration study received Special Protocol Assessment designation from the FDA. This in turn indicates that the trial is adequately designed to support a biologics license application (BLA) submission for registration if it is successful.
Athersys has technology licensing arrangements with companies like Bristol-Myers Squibb (BMY - Free Report) . These collaborations provide the company with the required capital to advance its pipeline further.
Our Take
We expect the company to further advance its lead program in ischemic stroke in 2017. The successful development of this program will be a significant boost for the company given the high potential of the market.
Zacks Rank & Other Stocks to Consider
Athersys currently carries a Zacks Rank #2 (Buy).
Other favorably placed stocks in the health care sector include Heska Corporation and Retrophin, Inc. . Both the stocks flaunt a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive earnings surprise in all the four trailing quarters with an average beat of 291.54%. Its share price increased 33.8% year to date.
Retrophin’s loss estimates narrowed from 85 cents 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
Want to learn more about the biotech market and what's hot now? Check out our recent podcast with an immunotherapy expert for additional information:
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>