EL7.AI
StocksMedium•23 October 2026•
4 min read

DiaMedica Enrolls 200th Participant in Stroke Trial, Awaits Analysis in 2027

Key Facts

1The company enrolled the 200th participant in the Phase 2/3 ReMEDy2 trial on October 22, 2026.
2The analysis will take place after the first 200 participants complete 90 days of follow-up and will be assessed by an independent board.
3The company expects to complete the interim analysis in the first quarter of 2027.
4If the trial continues, the final sample size will range from 300 to 728 participants.

DiaMedica Therapeutics announced on October 22, 2026, that it had enrolled the 200th participant in the pivotal Phase 2/3 ReMEDy2 trial of DM199, reaching the prespecified threshold for an interim analysis. The drug, also known as rinvecalinase alfa, is being developed to treat acute ischemic stroke. Reaching the threshold does not mean efficacy results are available; the analysis begins after the first 200 participants complete 90 days of follow-up. An independent data safety monitoring board will conduct the review, while the company remains blinded to the data. DiaMedica expects the analysis to be completed in the first quarter of 2027.

The independent board will assess two statistical options: sample-size re-estimation or a recommendation to stop the study for futility. The interim analysis therefore allows the trial’s course to be reviewed before it is completed, without the company seeing the results, according to its disclosure. If the study continues, the final sample size will be between 300 and 728 participants, according to the prespecified statistical plan. This range differs from the initial target of about 300 participants because sample-size re-estimation could change the total. The disclosure does not report a new clinical result or a judgment on the drug’s efficacy with the announcement that the 200th participant was enrolled.

ReMEDy2 was designed as a randomized, double-blind, placebo-controlled trial, with a target of about 300 participants at up to 100 sites worldwide. The primary efficacy endpoint measures the proportion of participants who score 0 or 1 on the modified Rankin Scale on day 90. The two scores reflect an excellent functional outcome under the scale specified in the study protocol. Participants receive DM199 or placebo for three weeks, with treatment to begin within 24 hours of stroke symptom onset. Final follow-up is completed after 90 days, the same period that precedes the review of data from the first 200 participants.

The company previously said enrollment had reached 75% of the 200-participant threshold required for the interim analysis and that it expected to complete it before the end of 2026. It then announced enrollment of the 200th participant in October and set the first quarter of 2027 as the expected timing for completion of the analysis. Clinical sites continue to enroll participants while participant number 200 completes the follow-up period and the review is conducted. This means enrollment does not stop when the threshold is reached, according to the company’s statement. The first quarter of 2027 remains the company’s announced timing for the analysis, not for reporting final trial results.

In a later analysis of a subgroup from the earlier ReMEDy1 trial, the company said 25% of participants who received DM199 achieved a score of 0 to 1 on the modified Rankin Scale after 90 days, compared with 10% of those who received placebo. The company described that subgroup as the closest to the target population in ReMEDy2. These are results from a later analysis of an earlier trial, not results from the awaited interim analysis of the current study. DM199 was also granted Fast Track designation by the U.S. Food and Drug Administration for acute ischemic stroke in September 2021. The company said more than 25 years have passed without approval of a new treatment for the condition.

The ReMEDy2 page describes the drug as investigational and says its safety and efficacy for treating acute ischemic stroke have not yet been established. In trading, DMAC shares closed at $8.63 on October 22, 2026, down 0.69% from the previous session, with 87.99 thousand shares traded. These are that day’s closing figures and do not change the fact that the announced milestone concerns enrollment progress and the timing of a future review. The next announced milestone is completion of follow-up for participants eligible for the analysis and the independent board’s review. The company expects to complete that review during the first quarter of 2027, while enrollment continues.