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Adverum Biotechnologies (ADVM) FDA Events

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FDA Events for Adverum Biotechnologies (ADVM)

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

Adverum Biotechnologies' Drugs in FDA Review

ixoberogene soroparvovec (Ixo-vec) - FDA Regulatory Timeline and Events

ixoberogene soroparvovec (Ixo-vec) is a drug developed by Adverum Biotechnologies for the following indication: For the treatment of wet age-related macular degeneration (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.

Ixo-vec - FDA Regulatory Timeline and Events

Ixo-vec is a drug developed by Adverum Biotechnologies for the following indication: For the Treatment of 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.

Adverum Biotechnologies FDA Events - Frequently Asked Questions

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

In the past two years, Adverum Biotechnologies (ADVM) has reported FDA regulatory activity for the following drugs: ixoberogene soroparvovec (Ixo-vec) and Ixo-vec.

The most recent FDA-related event for Adverum Biotechnologies occurred on March 3, 2025, involving Ixo-vec. The update was categorized as "Study Initiation," with the company reporting: "Adverum Biotechnologies, Inc. announced the initiation of the ARTEMIS Phase 3 study."

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

  • For the treatment of wet age-related macular degeneration (wet AMD) - ixoberogene soroparvovec (Ixo-vec)
  • For the Treatment of Wet AMD - Ixo-vec

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:ADVM) was last updated on 7/11/2025 by MarketBeat.com Staff
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