Benzinga | May 17, 2021 12:28PM EDT

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

* The FDA has signed off DiaMedica Therapeutics Inc's (NASDAQ: 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.