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ProQR Therapeutics (PRQR) FDA Events

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FDA Events for ProQR Therapeutics (PRQR)

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.

ProQR Therapeutics' Drugs in FDA Review

AX-0810 - FDA Regulatory Timeline and 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 Timeline and 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

However, the company does has had 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: AX-0810 and Axiomer.

The most recent FDA-related event for ProQR Therapeutics occurred on June 26, 2025, involving AX-0810. The update was categorized as "Clinical trial application," with the company reporting: "ProQR Therapeutics NV announced the submission of a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to initiate a Phase 1 clinical trial of its lead pipeline program AX-0810 targeting NTCP, a liver cell protein that transports bile acids into cells."

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

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

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 7/10/2025 by MarketBeat.com Staff
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