regulatory
confidence high
sentiment negative
materiality 0.85
FDA clinical hold on DiaMedica's ReMEDy2 trial for DM199 after 3 hypotension events
DiaMedica Therapeutics Inc.
- FDA placed clinical hold on Phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke after 3 SAEs of transient hypotension.
- Hypotension occurred shortly after IV dose; blood pressure recovered within minutes of stopping infusion; no injuries.
- Company attributes events to different IV bag materials causing higher drug absorption vs. prior ReMEDy1 trial.
- Plans to submit revised protocol with proportionate DM199 dose reduction and shorter infusion times to FDA.
- No further enrollment until FDA reviews analysis and proposed modifications and lifts the hold.