U.S. Markets open in 1 hr 38 mins
  • Gold

    -9.80 (-0.55%)
  • Silver

    +0.46 (+2.05%)

    -0.0034 (-0.2924%)
  • 10-Yr Bond

    +0.0120 (+0.91%)
  • Vix

    -3.49 (-14.33%)

    -0.0045 (-0.3282%)

    +0.5600 (+0.5127%)

    +638.63 (+1.48%)
  • CMC Crypto 200

    +49.07 (+4.72%)
  • FTSE 100

    +102.39 (+1.47%)
  • Nikkei 225

    -200.31 (-0.67%)

Athersys Gets FDA's RMAT Designation for Cell Therapy in ARDS

  • Oops!
    Something went wrong.
    Please try again later.
·3 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.

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.

Breakout Biotech Stocks with Triple-Digit Profit Potential

The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.

Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.

See these 7 breakthrough stocks now>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
QIAGEN N.V. (QGEN) : Free Stock Analysis Report
Emergent Biosolutions Inc. (EBS) : Free Stock Analysis Report
Athersys, Inc. (ATHX) : Free Stock Analysis Report
Horizon Therapeutics Public Limited Company (HZNP) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research