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PainReform (PRFX) FDA Events

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FDA Events for PainReform (PRFX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by PainReform (PRFX). Over the past two years, PainReform has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as PRF-110. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

PRF-110 - FDA Regulatory Timeline and Events

PRF-110 is a drug developed by PainReform for the following indication: To provide localized and extended post-operative analgesia. 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.

PainReform FDA Events - Frequently Asked Questions

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

In the past two years, PainReform (PRFX) has reported FDA regulatory activity for PRF-110.

The most recent FDA-related event for PainReform occurred on December 27, 2024, involving PRF-110. The update was categorized as "Provided Update," with the company reporting: "PainReform Ltd. nnounced an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy."

Currently, PainReform has one therapy (PRF-110) targeting the following condition: To provide localized and extended post-operative analgesia..

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:PRFX) was last updated on 7/10/2025 by MarketBeat.com Staff
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