Welcome to our dedicated page for Athersys news (Ticker: ATHX), a resource for investors and traders seeking the latest updates and insights on Athersys stock.
Athersys, Inc. (symbol: ATHX) is a leading clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative medications aimed at addressing significant and life-threatening diseases. The company leverages proprietary technologies to build a robust pipeline featuring highly differentiated, potential best-in-class therapeutics. These developments span multiple disease areas, including both stem cell therapy and pharmaceuticals.
Athersys is pioneering in the field of regenerative medicine with its flagship product, MultiStem®, an investigational stem cell therapy targeting critical conditions such as ischemic stroke, acute respiratory distress syndrome (ARDS), and other inflammatory and immune-mediated diseases. The company’s focus on extending and enhancing the quality of human life is evident through its diverse and strategic therapeutic programs.
Recent achievements include advancing clinical trials for MultiStem® and securing key partnerships that bolster the company’s research, development, and commercialization capabilities. Financially, Athersys remains committed to prudent management of resources, enabling sustained innovation and growth in its therapeutic pipeline.
With a strong emphasis on regulatory compliance, scientific rigor, and patient outcomes, Athersys continues to push the boundaries of medical science. The company’s mission is to deliver transformative therapies that address unmet medical needs, ultimately improving the lives of patients around the world.
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Athersys, Inc. (NASDAQ: ATHX) has announced modifications to its MASTERS-2 clinical trial protocol following a March 21, 2023 meeting with the FDA. The primary endpoint will now be assessed via mRS shift analysis at Day 365, extending the evaluation duration. Secondary endpoints will still include Day 90 shifts. Notably, eligibility caps on concomitant reperfusion therapy will be removed to align with current standards of care. The trial aims to enroll 300 patients, with over 50% enrollment already achieved. These changes are derived from insights gained during the MultiStem Phase 2 MASTERS-1 trial and the TREASURE trial in Japan, aiming to better reflect the treatment's potential benefits.
Athersys, Inc. (NASDAQ: ATHX), a cell therapy and regenerative medicine company, has announced the granting of a new patent for its Secure Integrated Freezer Unit (SIFU®) by the United States Patent and Trademark Office. This patent, U.S. Patent No. 11,566,834, marks a significant advancement in Athersys's intellectual property portfolio.
SIFU is a cryogenic storage device that simplifies logistics in hospital settings, enhancing access to therapies without the need for liquid nitrogen. Athersys is currently exploring commercialization partnerships while continuing to advance its MultiStem therapy in clinical trials for ischemic stroke.
Athersys, Inc. (NASDAQ: ATHX) announced the scheduling of a clinical Type B meeting with the U.S. Food & Drug Administration (FDA) to discuss modifications to its pivotal Phase 3 MASTERS-2 clinical trial for ischemic stroke. This follows the company receiving Regenerative Medicine Advanced Therapy (RMAT) and fast track designations for its MultiStem therapy (invimestrocel). The meeting is set for late March 2023, during which Athersys aims to establish more relevant primary and secondary outcomes for the trial based on earlier data. The company will provide further updates during a business call on February 14, 2023.
Athersys, Inc. (NASDAQ: ATHX) will hold a business update conference call on
Athersys, Inc. (NASDAQ: ATHX) announced its participation in two significant conferences: the International Stroke Conference 2023, taking place from February 8-10 in Houston, TX, and BioProcess International US West from February 27 to March 2 in San Diego, CA. Athersys invites registered attendees to schedule meetings with Ellen Gurley at ir@athersys.com. At the BioProcess International event, Vice President Senthil Ranganathan will present on March 1, discussing the commercialization pathway of MultiStem®, Athersys's allogeneic stem cell therapy. For more information, visit the respective conference websites.
Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine firm, announced its participation in two significant January conferences. The events include Advanced Therapies Week in Miami (January 17-20, 2023) and the 2nd Allogeneic Cell Therapies Summit Europe in London (January 30-February 1, 2023). Key presentations by COO Maia Hansen and VP Dr. Sarah Busch will focus on supply chain logistics and MultiStem® cell therapy for neurological indications, respectively. For further details, visit the event websites linked in the press release.
Athersys, Inc. (NASDAQ: ATHX) has completed enrollment in the second cohort of the MATRICS-1 trial for hemorrhagic trauma and reached the halfway mark in the MASTERS-2 trial for ischemic stroke. The MATRICS-1 trial is evaluating the safety of MultiStem cells manufactured via a new 3D process, while the MASTERS-2 trial shows increased patient enrollment due to effective site management and positive results from earlier studies. Athersys plans to engage with regulatory authorities for further updates, highlighting the potential of MultiStem in stroke treatment.
Athersys, Inc. (Nasdaq: ATHX) announced the appointment of Joseph Nolan to its Board of Directors, effective January 4, 2023. Nolan, an experienced biotechnology executive and current CEO of Jaguar Gene Therapy, brings over 30 years of experience in managing drug pipelines and launching successful biopharmaceutical products. His expertise is expected to strengthen Athersys' strategy and advance the clinical development of its MultiStem® therapy, which aims to address critical care indications.
Athersys, Inc. (NASDAQ: ATHX) reported its financial results for Q3 2022, unveiling a net loss of $13.7 million, down from $16.2 million year-over-year. The company raised $12 million through a direct offering and an additional $5.5 million post-quarter. A 1-for-25 reverse stock split was executed to meet Nasdaq requirements. MASTERS-2 clinical trial enrollment doubled compared to previous years. Research and development expenses decreased significantly to $12.4 million, with further reductions expected as restructuring concludes.
Athersys, Inc. (NASDAQ: ATHX) announced its participation in two key conferences in November 2022. The first is the Challenges and Opportunities for Mesenchymal Stem Cells digital conference on November 17-18, where Executive VP Robert W. Mays will be a keynote speaker discussing clinical trial challenges. A webcast will be available for registered participants. The second event is A.G.P.'s Biotech Conference on November 30, where Athersys management will engage in one-on-one meetings with institutional investors.
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