DiaMedica Stock Gains On Green Signal To Start Pivotal DM199 Trial In Ischemic Stroke

The FDA has signed off DiaMedica Therapeutics Inc's DMAC Investigational New Drug (IND) application to proceed with a pivotal Phase 2/3 study of DM199 (recombinant human tissue kallikrein-1or KLK1) for the treatment of patients with Acute Ischemic Stroke (AIS).
The upcoming pivotal ReMEDy2 trial will evaluate whether DM199 can improve three-month outcomes in AIS patients without other treatment options. It will enroll approximately 350 participants.
Endpoints will include the modified Rankin Scale, stroke recurrence, the National Institute of Health Stroke Score, Barthel Index, deaths, safety, and tolerability.
DiaMedica will remain blinded to the data in the interim.
Price Action: DMAC shares are up 6.9% at $6.95 on the last check Monday.