regulatory
confidence high
sentiment negative
materiality 0.75
FDA maintains clinical hold on DM199 stroke trial; company to conduct additional IV stability study
DiaMedica Therapeutics Inc.
- FDA requires additional in-use in vitro stability study of IV administration of DM199 to resolve clinical hold on ReMEDy2 trial.
- Company to request Type A meeting with FDA in coming weeks for guidance on lifting hold.
- Cash and investments $36.1M as of Sep 30, 2022, down from $45.1M at Dec 31, 2021; runway into Q4 2024.
- R&D expense Q3 2022 $1.6M (down from $2.3M Q3 2021); G&A $1.5M (up from $1.1M).
- Net cash used in operating activities $8.7M for 9mo 2022, compared to $9.4M in 9mo 2021.