Diamedica Sinks as FDA Places Clinical Hold on ReMEDy2 Trial

(Updates to include share price in the first paragraph.)

DiaMedica tumbles 35% in premarket trading after saying that an FDA hold was initiated as three serious adverse event reports related to clinically significant, transient hypotension (low blood pressure) occurred shortly after initiation of the intravenous dose of DM199.

• The company may not enroll added patients until it provides analysis of the events leading to or causing the hypotension and suggested protocol modifications
• DiaMedica plans to submit revised ReMEDy2 trial protocol to FDA for review in coming weeks
• Phase 2/3 ReMEDy2 trial studies the use of DM199 to treat acute ischemic ...