Athersys: An Ischemic Stroke Holy Grail? Find Out In Less Than A Month
Northern Fundamentals • 72 Comments
Northern Fundamentals • 72 Comments
Wed, Nov. 9, 4:13 PM
Tue, Nov. 8, 5:35 PM
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Wed, Sep. 28, 11:01 AM
Wed, Sep. 28, 9:21 AM
Wed, Sep. 28, 7:42 AM
- Athersys (ATHX) announces that it has received agreement from the FDA under a Special Protocol Assessment (SPA) 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. 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.
- MASTERS-2 will be a randomized, double-blind, placebo-controlled clinical trial designed to enroll 300 patients in North America and Europe. Participants will receive either a single intravenous dose of MultiStem cell therapy or placebo, in addition to standard of care. The primary endpoint will assess disability, as determined by modified Rankin Scale scores at Month 3, comparing the distribution or shift between the test and control groups. Secondary endpoints will include additional disability measurements.
- Ischemic stroke, the most common form of stroke, 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.
- MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors produced in response to signals of inflammation and tissue damage.
Tue, Aug. 9, 4:14 PM
Mon, Aug. 8, 5:35 PM
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Fri, May 6, 9:11 AM
Thu, May 5, 4:24 PM
- Athersys (NASDAQ:ATHX): Q1 EPS of $0.06 beats by $0.14.
- Revenue of $15.46M (+2017.8% Y/Y) beats by $13.61M.
Wed, May 4, 5:35 PM
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Wed, Mar. 30, 12:46 PM
Fri, Mar. 11, 12:46 PM
Fri, Mar. 11, 9:17 AM
Fri, Mar. 11, 8:20 AM
- Maxim doubles its price target on Athersys (NASDAQ:ATHX) to $10. Implied upside 446%.
- "Given the building data that suggests MultiStem works (and that stem cell therapy works in multiple modalities), we are lowering our risk rating (to 20%, from 30%). This drives a price target increase to $10.00, from $5.00.
- "While the challenge in reaching our price target remains the catalyst (a 2017 event), we believe that smart investors who take the time to evaluate the data will see that a positive outcome for MultiStem in stroke is probable. A positive outcome for Athersys would be transformative for both patients and the company.
- "Athersys announced that the one-year follow-up data from the phase II stroke study showed that patients receiving MultiStem (N=65) continued to improve and had a statistically significant higher rate of "excellent outcome" (P=0.02) versus placebo (N=61).
- "It's all in the data. Athersys continues to demonstrate that MultiStem has a meaningful clinical benefit in patients who have suffered an ischemic stroke and may extend the therapeutic window to 36 hours, as well as ameliorate some of the natural AEs (hyper inflammatory cascade), which tend to leave patients in an immune-depressed state (such as secondary infections and or pulmonary complications associated with stroke)."
- Shares +9% premarket.
- March 10: Athersys up 9.3% after Q4 swing to profit
- March 10: Athersys CEO Gil Van Bokkelen on Q4 2015 Results
- Jan. 20: Top Stock Idea For 2016? - Athersys, A Beaten Down Stem Cell Stock With Great Upside
Thu, Mar. 10, 5:36 PM
- Athersys (NASDAQ:ATHX) is up 9.3% after hours, as a Q4 profit beat an expected loss after the company fully recognized a Chugai license fee.
- Net income swung to a gain of $3.6M vs. a year-ago loss of $6.6M. The company fully recognized a $10M license fee it got from Chugai after the two terminated a collaboration in October.
- Grant revenues were up, and R&D expenses fell slightly to $5.3M.
- Conference call link
Thu, Mar. 10, 4:10 PM
- Athersys (NASDAQ:ATHX): Q4 EPS of $0.04 beats by $0.13.
- Revenue of $10.6M (+4316.7% Y/Y) beats by $6.88M.