Free Trial

Eupraxia Pharmaceuticals (EPRX) FDA Events

Eupraxia Pharmaceuticals logo
$5.46 -0.13 (-2.33%)
As of 07/9/2025 03:47 PM Eastern
FDA Events for Eupraxia Pharmaceuticals (EPRX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Eupraxia Pharmaceuticals (EPRX). Over the past two years, Eupraxia Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as EP-104GI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

EP-104GI - FDA Regulatory Timeline and Events

EP-104GI is a drug developed by Eupraxia Pharmaceuticals for the following indication: For Treatment of Eosinophilic Esophagitis. 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.

Eupraxia Pharmaceuticals FDA Events - Frequently Asked Questions

As of now, Eupraxia Pharmaceuticals (EPRX) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Eupraxia Pharmaceuticals (EPRX) has reported FDA regulatory activity for EP-104GI.

The most recent FDA-related event for Eupraxia Pharmaceuticals occurred on July 8, 2025, involving EP-104GI. The update was categorized as "Dose Update," with the company reporting: "Eupraxia Pharmaceuticals Inc. announced the first patient dosed in the Phase 2b randomized, placebo-controlled portion of the RESOLVE clinical trial evaluating EP-104GI, an investigational treatment for eosinophilic esophagitis ("EoE")."

Currently, Eupraxia Pharmaceuticals has one therapy (EP-104GI) targeting the following condition: For Treatment of Eosinophilic Esophagitis.

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:EPRX) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners