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ProQR Therapeutics (PRQR) FDA Approvals

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$2.08 -0.02 (-0.95%)
Closing price 08/1/2025 04:00 PM Eastern
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ProQR Therapeutics' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by ProQR Therapeutics (PRQR). Over the past two years, ProQR Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AX-0810 and Axiomer. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

AX-0810 FDA Regulatory Events

AX-0810 is a drug developed by ProQR Therapeutics for the following indication: For cholestatic diseases. 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.

Axiomer FDA Regulatory Events

Axiomer is a drug developed by ProQR Therapeutics for the following indication: Editing Technology Adenosine Deaminase Acting on RNA). 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.

ProQR Therapeutics FDA Events - Frequently Asked Questions

In the past two years, ProQR Therapeutics (PRQR) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, ProQR Therapeutics (PRQR) has reported FDA regulatory activity for the following drugs: Axiomer and AX-0810.

The most recent FDA-related event for ProQR Therapeutics occurred on July 28, 2025, involving Axiomer. The update was categorized as "Provided Update," with the company reporting: "ProQR Therapeutics NV announced that it will participate in the RNA Editing Summit taking place July 29-31, 2025, in Boston, MA."

Current therapies from ProQR Therapeutics in review with the FDA target conditions such as:

  • Editing Technology Adenosine Deaminase Acting on RNA) - Axiomer
  • For cholestatic diseases - AX-0810

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:PRQR) was last updated on 8/2/2025 by MarketBeat.com Staff
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