Athersys, Inc. ATHX announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its MultiStem cell therapy for the treatment of acute respiratory distress syndrome (ARDS).
The RMAT designation was created under the 21st Century Cures Act and is granted to speed up the development and review of regenerative therapies that target serious or life-threatening conditions. The designation also indicates that the cell therapy product is eligible and has the potential to address the unmet medical needs for that disease.
The MultiStem cell therapy was granted a Fast Track tag by the FDA for the given indication in May 2019.
Following the latest development, MultiStem became the only cell therapy program that has both Fast Track and RMAT designations from the FDA for ARDS.
Athersys recently completed an exploratory phase I/II MUST-ARDS study on MultiStem cell therapy for the treatment of ARDS. Data from the same showed that treatment with MultiStem cell therapy led to lower mortality, fewer days on ventilator, lesser intensive care unit days and a better quality of life, a year post-ARDS compared to patients who received placebo.
Shares of Athersys have rallied 55.2% so far this year against the industry’s decrease of 0.1%.
Notably, the company is also currently evaluating the administration of MultiStem for the treatment of ischemic stroke in phase III MASTERS-2 study. The study is currently ongoing and enrolling patients. MultiStem for ischemic stroke also enjoys an RMAT designation.
This apart, Athersys initiated the phase II/III MACOVIA study in August 2020, evaluating MultiStem cell therapy for the treatment of COVID-19-induced ARDS. This study is currently recruiting patients and is designed to evaluate the safety, tolerability and dose levels of MultiStem cell therapy for the given indication. The primary efficacy endpoints are comparing the number of ventilator-free days through day 28 compared to placebo.
Zacks Rank & Stocks to Consider
Athersys currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Emergent BioSolutions Inc. EBS, Horizon Therapeutics Public Limited Company HZNP and QIAGEN N.V. QGEN, all presently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have been revised 55.5% upward for 2020 and 37.3% for 2021 over the past 60 days. The stock has surged 89.5% year to date.
Horizon Therapeutics’ earnings estimates have moved 49.7% north for 2020 and 49.6% for 2021 over the past 60 days. The stock has skyrocketed 120.4% year to date.
QIAGEN’s earnings estimates have been revised 10.6% upward for 2020 and 22.5% for 2021 over the past 60 days. The stock has soared 50.1% year to date.
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