DiaMedica Receives FDA Feedback on DM199
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 16 2026
0mins
DiaMedica Therapeutics announced that it has received a written response from the U.S. Food and Drug Administration, FDA, regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 for the treatment of preeclampsia. DiaMedica believes, based on the FDA's feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug, IND, application, provided that DiaMedica can demonstrate sufficient evidence of DM199 exposure and enzymatic activity throughout the previous completed rat study, as well as adequate pharmacologic effect in rats to support their use as an appropriate toxicology species. To address the FDA's request, DiaMedica is initiating a pharmacokinetic and pharmacologic activity study of DM199 in rats and is summarizing the recently completed study data intended to support the pharmacodynamic activity of DM199 in this species. Upon completion of the rat PK study, DiaMedica plans to submit the requested information to FDA for review.
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Analyst Views on DMAC
Wall Street analysts forecast DMAC stock price to rise
4 Analyst Rating
4 Buy
0 Hold
0 Sell
Strong Buy
Current: 6.280
Low
12.00
Averages
17.00
High
25.00
Current: 6.280
Low
12.00
Averages
17.00
High
25.00
About DMAC
DiaMedica Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people suffering from preeclampsia (PE) and acute ischemic stroke (AIS). The Company’s lead candidate, DM199, is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of pre-eclampsia, acute ischemic stroke and other vascular diseases. DM199 (rinvecalinase alfa) is a recombinant form of human tissue kallikrein-1 (rhKLK1) in clinical development for preeclampsia and acute ischemic stroke. KLK1 is a serine protease enzyme that is involved in the regulation of diverse physiological processes via a molecular mechanism that increases the production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factors. In the treatment of preeclampsia, DM199 is intended to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
First Clinical Evaluation of DM199 for Fetal Growth Restriction
- Trial Initiation: DiaMedica Therapeutics has announced the dosing of the first two patients in a Phase 2 clinical trial evaluating DM199 (rinvecalinase alfa) for fetal growth restriction (FGR), with plans to enroll up to 30 patients to assess safety and tolerability.
- Urgent Market Need: FGR affects approximately 10% of pregnancies globally, with no approved pharmacologic treatments available; DM199, as a recombinant human tissue kallikrein-1, may change this landscape by improving maternal uterine artery blood flow, potentially reducing neonatal mortality and long-term health risks.
- Scientific Rationale: A white paper released by DiaMedica outlines the potential of DM199 in treating FGR, emphasizing its mechanism of enhancing placental perfusion through maternal vessel dilation, which could make it the first therapy addressing this unmet medical need.
- Clear Research Objectives: The primary goal of the trial is to evaluate the safety of DM199, with exploratory efficacy endpoints including uterine artery vascular resistance, umbilical artery Doppler findings, and fetal growth trajectory, which, if successful, could provide new treatment options for FGR patients.
See More
DiaMedica Plans Pharmacokinetic Study for Preeclampsia
- Positive FDA Feedback: DiaMedica received a written response from the FDA indicating that its previously completed rat reproductive toxicity study may be sufficient to support the IND application for DM199, instilling confidence in the company's future research endeavors.
- Initiation of PK Study: To address the FDA's request, DiaMedica is launching a pharmacokinetic and pharmacologic activity study of DM199 in rats, which is expected to provide necessary data on drug exposure and enzymatic activity, thereby advancing its clinical development process.
- International Research Expansion: DiaMedica plans to initiate a preeclampsia study in Canada and the UK, showcasing its global strategy and potentially opening up broader market opportunities for its products.
- Clinical Potential of DM199: As a recombinant form of human tissue kallikrein-1, DM199 holds significant clinical application potential for treating serious conditions like preeclampsia, and successful clinical trials will further solidify its market position.
See More
DiaMedica to Present at 2026 Jefferies Global Healthcare Conference
- Conference Announcement: DiaMedica Therapeutics Inc. will present at the Jefferies Global Healthcare Conference in New York from June 2-4, 2026, with a corporate presentation scheduled for June 4 at 3:45 PM ET, highlighting its clinical-stage biopharmaceutical advancements.
- Product Focus: The company is dedicated to developing innovative treatments for preeclampsia, fetal growth restriction, and acute ischemic stroke, aiming to enhance the quality of life for patients suffering from serious ischemic diseases, underscoring its strategic significance in the healthcare sector.
- Lead Candidate: DiaMedica's lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, which has been established as an effective therapy in Asia for treating acute ischemic stroke and other vascular diseases, indicating its potential in the global market.
- Investor Relations: The company encourages interested investors to arrange one-on-one meetings with management to discuss its R&D progress and market strategies, reflecting its commitment to investor communication.
See More
DiaMedica's DM199 Trial Surpasses 75% Enrollment for Interim Analysis
- Enrollment Milestone: DiaMedica Therapeutics announced that its ReMEDy2 trial for DM199 has reached 75% of the 200-patient enrollment threshold, indicating that 150 patients have been enrolled, reflecting the dedication of clinical sites and the urgent need for new treatments for acute ischemic stroke patients.
- Interim Analysis Plan: An independent Data Safety Monitoring Board (DSMB) will conduct an interim analysis to assess whether a sample size re-estimation is recommended, with the final sample size expected to range between 300 and 728 patients, ensuring the trial's statistical power and integrity.
- Clinical Trial Design: The ReMEDy2 trial is an adaptive, randomized, double-blind, placebo-controlled study, with the primary efficacy endpoint being the modified Rankin Score (mRS) at Day 90, which will directly impact the clinical application prospects of DM199 in treating acute ischemic stroke.
- Future Outlook: The interim analysis is anticipated to be completed before the end of 2026, marking a critical inflection point that will provide essential data to guide the development path of DM199, potentially influencing the company's future R&D direction and funding allocation.
See More
DiaMedica Reports Q1 2026 Financial Results and Clinical Updates
- Clinical Trial Progress: DiaMedica's DM199 is currently enrolling in the Phase 2 IST clinical trial for preeclampsia, with data expected in Q2 2026, which may provide critical dosing information for a potential multinational Phase 3 program.
- Acute Ischemic Stroke Study: The ReMEDy2 trial has surpassed 70% of the required enrollment, with an interim analysis planned for Q4 2026, which will determine the final number of participants needed to complete the study, thus impacting the overall timeline of the clinical trial.
- Financial Status Update: As of March 31, 2026, DiaMedica reported cash and short-term investments of $51.3 million, which is anticipated to support corporate operations through 2027, despite a decrease from $59.9 million at the end of 2025, indicating a stable financial position for ongoing clinical research.
- Increased R&D Spending: R&D expenses for Q1 2026 reached $8.0 million, significantly up from $5.7 million in Q1 2025, primarily driven by the ongoing ReMEDy2 trial and its global expansion, reflecting the company's strategic focus on research and development investment.
See More
DiaMedica Therapeutics Stock Shows Oversold Signal
- Oversold Signal: DiaMedica Therapeutics Inc (Ticker: DMAC) hit an RSI of 28.4 during Wednesday's trading, indicating an oversold condition that suggests the recent heavy selling may be exhausting, prompting bullish investors to seek buying opportunities.
- Price Fluctuation: DMAC shares traded as low as $6.065, with the current price at $6.19, showing a significant recovery from the 52-week low of $3.26, yet still far below the 52-week high of $10.4195, reflecting market uncertainty.
- Market Comparison: Compared to the S&P 500 ETF (SPY) with an RSI of 57.1, DMAC's low RSI may attract bullish investors who see potential for a price rebound, potentially stimulating buying interest.
- Investor Sentiment: While DMAC is currently in an oversold state, investors should cautiously assess market sentiment and fundamentals to avoid making impulsive decisions in an uncertain market environment.
See More
First Clinical Evaluation of DM199 for Fetal Growth Restriction
- Trial Initiation: DiaMedica Therapeutics has announced the dosing of the first two patients in a Phase 2 clinical trial evaluating DM199 (rinvecalinase alfa) for fetal growth restriction (FGR), with plans to enroll up to 30 patients to assess safety and tolerability.
- Urgent Market Need: FGR affects approximately 10% of pregnancies globally, with no approved pharmacologic treatments available; DM199, as a recombinant human tissue kallikrein-1, may change this landscape by improving maternal uterine artery blood flow, potentially reducing neonatal mortality and long-term health risks.
- Scientific Rationale: A white paper released by DiaMedica outlines the potential of DM199 in treating FGR, emphasizing its mechanism of enhancing placental perfusion through maternal vessel dilation, which could make it the first therapy addressing this unmet medical need.
- Clear Research Objectives: The primary goal of the trial is to evaluate the safety of DM199, with exploratory efficacy endpoints including uterine artery vascular resistance, umbilical artery Doppler findings, and fetal growth trajectory, which, if successful, could provide new treatment options for FGR patients.
See More
DiaMedica Plans Pharmacokinetic Study for Preeclampsia
- Positive FDA Feedback: DiaMedica received a written response from the FDA indicating that its previously completed rat reproductive toxicity study may be sufficient to support the IND application for DM199, instilling confidence in the company's future research endeavors.
- Initiation of PK Study: To address the FDA's request, DiaMedica is launching a pharmacokinetic and pharmacologic activity study of DM199 in rats, which is expected to provide necessary data on drug exposure and enzymatic activity, thereby advancing its clinical development process.
- International Research Expansion: DiaMedica plans to initiate a preeclampsia study in Canada and the UK, showcasing its global strategy and potentially opening up broader market opportunities for its products.
- Clinical Potential of DM199: As a recombinant form of human tissue kallikrein-1, DM199 holds significant clinical application potential for treating serious conditions like preeclampsia, and successful clinical trials will further solidify its market position.
See More
DiaMedica to Present at 2026 Jefferies Global Healthcare Conference
- Conference Announcement: DiaMedica Therapeutics Inc. will present at the Jefferies Global Healthcare Conference in New York from June 2-4, 2026, with a corporate presentation scheduled for June 4 at 3:45 PM ET, highlighting its clinical-stage biopharmaceutical advancements.
- Product Focus: The company is dedicated to developing innovative treatments for preeclampsia, fetal growth restriction, and acute ischemic stroke, aiming to enhance the quality of life for patients suffering from serious ischemic diseases, underscoring its strategic significance in the healthcare sector.
- Lead Candidate: DiaMedica's lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, which has been established as an effective therapy in Asia for treating acute ischemic stroke and other vascular diseases, indicating its potential in the global market.
- Investor Relations: The company encourages interested investors to arrange one-on-one meetings with management to discuss its R&D progress and market strategies, reflecting its commitment to investor communication.
See More
DiaMedica's DM199 Trial Surpasses 75% Enrollment for Interim Analysis
- Enrollment Milestone: DiaMedica Therapeutics announced that its ReMEDy2 trial for DM199 has reached 75% of the 200-patient enrollment threshold, indicating that 150 patients have been enrolled, reflecting the dedication of clinical sites and the urgent need for new treatments for acute ischemic stroke patients.
- Interim Analysis Plan: An independent Data Safety Monitoring Board (DSMB) will conduct an interim analysis to assess whether a sample size re-estimation is recommended, with the final sample size expected to range between 300 and 728 patients, ensuring the trial's statistical power and integrity.
- Clinical Trial Design: The ReMEDy2 trial is an adaptive, randomized, double-blind, placebo-controlled study, with the primary efficacy endpoint being the modified Rankin Score (mRS) at Day 90, which will directly impact the clinical application prospects of DM199 in treating acute ischemic stroke.
- Future Outlook: The interim analysis is anticipated to be completed before the end of 2026, marking a critical inflection point that will provide essential data to guide the development path of DM199, potentially influencing the company's future R&D direction and funding allocation.
See More
DiaMedica Reports Q1 2026 Financial Results and Clinical Updates
- Clinical Trial Progress: DiaMedica's DM199 is currently enrolling in the Phase 2 IST clinical trial for preeclampsia, with data expected in Q2 2026, which may provide critical dosing information for a potential multinational Phase 3 program.
- Acute Ischemic Stroke Study: The ReMEDy2 trial has surpassed 70% of the required enrollment, with an interim analysis planned for Q4 2026, which will determine the final number of participants needed to complete the study, thus impacting the overall timeline of the clinical trial.
- Financial Status Update: As of March 31, 2026, DiaMedica reported cash and short-term investments of $51.3 million, which is anticipated to support corporate operations through 2027, despite a decrease from $59.9 million at the end of 2025, indicating a stable financial position for ongoing clinical research.
- Increased R&D Spending: R&D expenses for Q1 2026 reached $8.0 million, significantly up from $5.7 million in Q1 2025, primarily driven by the ongoing ReMEDy2 trial and its global expansion, reflecting the company's strategic focus on research and development investment.
See More
DiaMedica Therapeutics Stock Shows Oversold Signal
- Oversold Signal: DiaMedica Therapeutics Inc (Ticker: DMAC) hit an RSI of 28.4 during Wednesday's trading, indicating an oversold condition that suggests the recent heavy selling may be exhausting, prompting bullish investors to seek buying opportunities.
- Price Fluctuation: DMAC shares traded as low as $6.065, with the current price at $6.19, showing a significant recovery from the 52-week low of $3.26, yet still far below the 52-week high of $10.4195, reflecting market uncertainty.
- Market Comparison: Compared to the S&P 500 ETF (SPY) with an RSI of 57.1, DMAC's low RSI may attract bullish investors who see potential for a price rebound, potentially stimulating buying interest.
- Investor Sentiment: While DMAC is currently in an oversold state, investors should cautiously assess market sentiment and fundamentals to avoid making impulsive decisions in an uncertain market environment.
See More
