DiaMedica Engages FDA for DM199 Preclinical Study Clarity
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 18 2025
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Source: Newsfilter
- FDA Meeting Outcomes: DiaMedica's in-person meeting with the FDA confirmed the need for an additional non-clinical study to evaluate DM199 for preeclampsia, with results expected by Q2 2026, thereby providing crucial regulatory clarity for the IND submission.
- Clinical Trial Progress: The ongoing Phase 2 trial of DM199 in South Africa has dosed over 30 women with late-stage preeclampsia, with interim data showing significant reductions in blood pressure and no placental transfer, indicating promising safety and efficacy.
- R&D Strategy: As the first pharmaceutical-grade recombinant form of human tissue kallikrein-1, DM199 targets preeclampsia, fetal growth restriction, and acute ischemic stroke, showcasing potential competitiveness in the global market, particularly in Asia.
- Future Outlook: DiaMedica plans to maintain ongoing engagement with the FDA to advance DM199's development, aiming to provide new treatment options for women facing preeclampsia, aligning with global demands for improved maternal and neonatal health.
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Analyst Views on DMAC
Wall Street analysts forecast DMAC stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for DMAC is 17.00 USD with a low forecast of 12.00 USD and a high forecast of 25.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 8.470
Low
12.00
Averages
17.00
High
25.00
Current: 8.470
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.
DiaMedica Therapeutics Grants 50,000 Stock Options to New Employee
- Incentive Options: On January 15, 2026, DiaMedica granted 50,000 stock options to a newly hired non-executive employee as a material inducement for their acceptance of employment, aligning with Nasdaq Listing Rule 5635(c)(4), highlighting the company's commitment to attracting talent.
- Exercise Price: The options have an exercise price of $8.54 per share, matching the closing price of the company's common stock on the grant date, ensuring that employees have a strong financial incentive to remain with the company long-term.
- Vesting Schedule: The options will vest 25% on the one-year anniversary of the grant date, with the remaining 75% vesting in 12 quarterly installments thereafter, designed to encourage continued service and enhance employee loyalty.
- Strategic Focus: DiaMedica is dedicated to developing innovative treatments for preeclampsia, fetal growth restriction, and acute ischemic stroke, and this stock option grant not only attracts talent but also supports its long-term growth in the biopharmaceutical sector.
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DiaMedica Therapeutics Grants 50,000 Stock Options to New Employee
- Options Grant: On January 15, 2026, DiaMedica Therapeutics granted 50,000 stock options to a newly hired non-executive employee as a material inducement for their acceptance of employment, in accordance with Nasdaq Listing Rule 5635(c)(4).
- Exercise Price: The options have an exercise price of $8.54 per share, matching the closing price of the company's common stock on January 15, 2026, indicating the company's commitment to employee incentives.
- Vesting Schedule: The options will vest 25% on the one-year anniversary of the grant date, with the remaining 75% vesting in 12 quarterly installments, ensuring long-term incentives for employees who continue their service with the company.
- Strategic Implications: This options grant not only enhances the company's ability to attract and retain talent but also reflects DiaMedica's ongoing commitment to growth in the clinical-stage biopharmaceutical sector and investment in its workforce.
Continue Reading