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Aura Biosciences (AURA) FDA Events

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FDA Events for Aura Biosciences (AURA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Aura Biosciences (AURA). Over the past two years, Aura Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AU-011. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

AU-011 - FDA Regulatory Timeline and Events

AU-011 is a drug developed by Aura Biosciences for the following indication: Uveal Melanoma (Includes Choroidal Melanoma). 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.

Aura Biosciences FDA Events - Frequently Asked Questions

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

In the past two years, Aura Biosciences (AURA) has reported FDA regulatory activity for AU-011.

The most recent FDA-related event for Aura Biosciences occurred on March 24, 2025, involving AU-011. The update was categorized as "Positive Data," with the company reporting: "Aura Biosciences, Inc. announced positive data from a completed Phase 1 window of opportunity trial of bel-sar (AU-011) in patients with NMIBC."

Currently, Aura Biosciences has one therapy (AU-011) targeting the following condition: Uveal Melanoma (Includes Choroidal Melanoma).

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:AURA) was last updated on 7/9/2025 by MarketBeat.com Staff
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