Athersys to present at 2017 Cell & Gene Meeting on the Mesa and announces regenerative medicine advanced therapy designation from FDA

Athersys

5 October 2017 - Athersys announced today that Robert W. Mays, Ph.D., Vice President, Regenerative Medicine and Head of Neuroscience Programs, will present at the annual Partnering Forum as part of the Cell & Gene Meeting on the Mesa to be held October 4-6 in La Jolla, California.

Dr. Mays will provide a brief overview of the Company's neuroscience programs, focusing on the Phase 3 clinical program for ischaemic stroke, which previously received special Protocol Assessment and fast track designations from the U.S. FDA, and recently obtained a Final Scientific Advice positive opinion from the European Medicines Agency.

The Company is also pleased to announce that it has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, recently established under the 21st Century Cures Legislation. The RMAT designation may be obtained for eligible cell therapy and other regenerative medicine and advanced therapies when the FDA agrees that preliminary clinical evidence indicates that the therapy has demonstrated the potential to address unmet medical needs for a serious or life threatening disease or condition. The designation enables sponsors to discuss with the FDA multidisciplinary strategic development plans, including expediting manufacturing development plans for commercialisation to support priority review and accelerated approval.

Read Athersys press release

Michael Wonder

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Michael Wonder

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Outcome , US , Cellular therapy