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DiaMedica Therapeutics (DMAC) FDA Approvals

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DiaMedica Therapeutics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by DiaMedica Therapeutics (DMAC). Over the past two years, DiaMedica Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as DM199. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

DM199 FDA Regulatory Timeline and Events

DM199 is a drug developed by DiaMedica Therapeutics for the following indication: Chronic Kidney Disease Stage II or III. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

DiaMedica Therapeutics FDA Events - Frequently Asked Questions

As of now, DiaMedica Therapeutics (DMAC) has not received any FDA approvals for its therapy in the last two years.

In the past two years, DiaMedica Therapeutics (DMAC) has reported FDA regulatory activity for DM199.

The most recent FDA-related event for DiaMedica Therapeutics occurred on July 17, 2025, involving DM199. The update was categorized as "Positive Results," with the company reporting: "DiaMedica Therapeutics Inc. announced positive interim results from Part 1a of the Phase 2 study of DM199 for the treatment of preeclampsia."

Currently, DiaMedica Therapeutics has one therapy (DM199) targeting the following condition: Chronic Kidney Disease Stage II or III.

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:DMAC) was last updated on 8/2/2025 by MarketBeat.com Staff
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