EMA on board with Auris Med's late-stage study of AM-111 in profound hearing loss; shares up 17% premarket

|About: Auris Medical Holding ... (EARS)|By:, SA News Editor

Auris Medical Holding (NASDAQ:EARS) is up 17% premarket on increased volume in response to its announcement that the European Medicines Agency (EMA) has signed off on the design, endpoints and statistical plan for a Phase 3 clinical trial assessing AM-111 in patients with acute profound hearing loss.

The company also says the EMA provided "important guidance" on a regulatory path forward and maintenance of AM-111's Orphan Drug designation but does not provide the details. It plans to do so on May 15 with its Q1 earnings release.

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