regulatory
confidence high
sentiment negative
materiality 0.70
FDA maintains clinical hold on DiaMedica's ReMEDy2 stroke trial; cash $36.1M
DiaMedica Therapeutics Inc.
- FDA requires additional in-use IV stability study (tubing + pump) to lift clinical hold on Phase 2/3 ReMEDy2 trial.
- Cash, equivalents, and marketable securities were $36.1M as of Sept 30, 2022; Q3 cash burn $2.3M.
- Company will request Type A FDA meeting to confirm study design and gain guidance toward resumption.
- Three transient hypotension cases led to hold; all patients recovered without lasting effects.