Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure. Many Athersys investors appeared to read the results as bad news for Athersys' ongoing pivotal phase III stroke study, Masters-2.
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure.
Biopharma companies that are focused on cell therapies have reported promising clinical trial results in their ability to treat acute respiratory distress syndrome (ARDS), a condition that has shown to be a significant contributor to higher mortality in COVID-19 cases.
The biotech industry's rapid response to COVID-19, a pivot of global scope, is driving a broad array of approaches to tackling the infection. On Monday, the first day of BIO's virtual convention, the trade group gathered some of the effort's leading voices to take stock of how those efforts are shaping up.
The biotech industry's rapid response to COVID-19, a pivot of global scope, is driving a broad array of approaches to tackling the infection. On Monday, the first day of BIO's virtual convention, the trade group gathered some of the effort's leading voices to take stock of how those efforts are shaping up. It put a spotlight on work underway at Athersys Inc., Regeneron Inc., SAB Biotherapeutics Inc., Takeda Pharmaceutical Co. Ltd. and Vir Biotechnology Inc.
Stem cells haven’t exactly panned out as hoped when it comes to approved therapeutics. There are only a couple that have received a nod from the FDA in very specific indications. But the ongoing COVID-19 pandemic could push stem cells back into the limelight and more firmly establish them as therapeutically relevant.