Athersys (ATHX) Stock Is Flying On RMAT Designation

Athersys ATHX Stock News

Athersys Inc (NASDAQ: ATHX) is making a run for the top in the market this morning, and for good reason. The company announced that the FDA has granted RMAT designation for its MultiStem cell therapy. Here’s what’s going on:

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ATHX Stock Flies On RMAT Designation

In the press release, Athersys said that the FDA has granted Regenerative Medicine Advanced Therapy, or RMAT, designation for MultiStem cell therapy. In particular, the RMAT designation covers the use of the company’s MultiStem cell therapy as a potential option for acute respiratory distress syndrom, or ARDS, a major consequence of COVID-19.

In the release, ATHX said that the RMAT designation gives sponsors the ability to work closely with the FDA and receive their guidance on expediting development of their products. This increased communication also includes advise from the FDA on generating the evidence needed to support approval in an efficient manner.

Furthermore, as a result of the RMAT designation, ATHX is invited to schedule a Type B meeting with the FDA to discuss multidisciplinary strategic development plans. This will ultimately help to expedite manufacturing development for commercialization to support priority review and/or accelerated review.

In a statement, Dr. Manal Morsy, Senior Vice President and Head of Global Regulatory Affairs at ATHX, had the following to offer:

We are very pleased to have received our second MultiStem program RMAT designation. We have enjoyed close and highly efficient interactions with the FDA on our RMAT-designated ischemic stroke program and are looking forward to similar benefits and advantages of this Expedited Program for Regenerative Medicine Therapies for Serious Conditions RMAT designation, this time for ARDS.

This News Is Huge

The news released by Athersys is overwhelmingly positive. RMAT designation is a game changer in the development of MultiStem cell therapy as a potential option for those suffering with some of the most severe COVID-19 syptoms.

As the race to a vaccine continues, so too does the race to an effective treatment option, and this designation gives ATHX a competitive advantage in that race. All in all, ATHX stock is one to keep a close eye on.

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