DiaMedica files clinical hold response with FDA for ReMEDy2 trial of DM199 in AIS

DiaMedica Therapeutics Inc.

Filed complete clinical hold response with FDA on May 19, 2023 to lift hold on Phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke.
Protocol amendment includes reduced IV dose of DM199 and additional measures to reduce risk of severe hypotension in participants.
Investor presentation on ReMEDy2 status furnished as Exhibit 99.1 for use at conferences and meetings.
No FDA decision timeline disclosed; clinical hold remains in effect pending review.

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