Free Trial

REGENXBIO (RGNX) FDA Events

REGENXBIO logo
$9.17 +0.43 (+4.92%)
Closing price 07/9/2025 04:00 PM Eastern
Extended Trading
$9.35 +0.18 (+1.97%)
As of 07:13 AM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for REGENXBIO (RGNX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by REGENXBIO (RGNX). Over the past two years, REGENXBIO has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ABBV-RGX-314, RGX-121, and RGX-202. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

REGENXBIO's Drugs in FDA Review

ABBV-RGX-314 - FDA Regulatory Timeline and Events

ABBV-RGX-314 is a drug developed by REGENXBIO for the following indication: In patients with wet AMD. 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.

RGX-121 - FDA Regulatory Timeline and Events

RGX-121 is a drug developed by REGENXBIO for the following indication: MPS II (Hunter Syndrome). 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.

RGX-202 - FDA Regulatory Timeline and Events

RGX-202 is a drug developed by REGENXBIO for the following indication: Duchenne Muscular Dystrophy. 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.

REGENXBIO FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, REGENXBIO (RGNX) has reported FDA regulatory activity for the following drugs: RGX-121, RGX-202 and ABBV-RGX-314.

The most recent FDA-related event for REGENXBIO occurred on June 5, 2025, involving RGX-202. The update was categorized as "Positive Data," with the company reporting: "REGENXBIO Inc announced new positive interim data from the Phase I/II AFFINITY DUCHENNE trial."

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

  • MPS II (Hunter Syndrome) - RGX-121
  • Duchenne Muscular Dystrophy - RGX-202
  • In patients with wet AMD - ABBV-RGX-314

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