Adverum Biotechnologies' Drug in the FDA Approval Process
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
Ixo-vec. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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.
- Drug:
- Ixo-vec
- Announced Date:
- September 22, 2025
- Indication:
- For the Treatment of Wet AMD
Announcement
Adverum Biotechnologies, Inc announced it has notified sites that it plans to complete screening in ARTEMIS, its first pivotal Phase 3 trial evaluating Ixo-vec in wet age-related macular degeneration (wet AMD) by September 30, seven months after initiation, because the company now expects full enrollment of at least 284 treatment-naïve and treatment experienced patients in 4Q 2025 and data readout in 1Q 2027.
AI Summary
Adverum Biotechnologies, a clinical-stage gene therapy company, said it will complete screening for its ARTEMIS Phase 3 trial by September 30, just seven months after starting. ARTEMIS tests Ixo-vec, a one-time intravitreal gene therapy for wet age-related macular degeneration (wet AMD).
The study will enroll at least 284 patients, including both treatment-naïve and previously treated individuals. By moving quickly through screening, the company aims to finish full enrollment by the fourth quarter of 2025, earlier than initially planned.
Participants receive a single injection of Ixo-vec, which is designed to deliver long-term benefits and reduce the need for frequent anti-VEGF shots. The trial compares this approach against standard aflibercept treatment.
Adverum now expects to share ARTEMIS topline data in the first quarter of 2027, reflecting the accelerated timeline for this potential "one and done" therapy.
Read Announcement- Drug:
- Ixo-vec
- Announced Date:
- March 3, 2025
- Indication:
- For the Treatment of Wet AMD
Announcement
Adverum Biotechnologies, Inc. announced the initiation of the ARTEMIS Phase 3 study.
AI Summary
Adverum Biotechnologies, Inc. has started the ARTEMIS Phase 3 study, a pivotal trial that could lead to a new gene therapy for wet age-related macular degeneration (AMD). This study is the first to test a one-time intravitreal (IVT) injection of Ixo-vec, aiming to provide a long-term treatment option compared to the current standard of care. The trial will compare a single Ixo-vec injection to the approved treatment with aflibercept, given every eight weeks, in about 284 patients, including those who are treatment-naïve and those who have been previously treated.
The study is designed to assess if Ixo-vec is no worse than aflibercept in improving vision over one year. Before receiving Ixo-vec or continuing with aflibercept, all patients will get three loading doses of aflibercept. This trial represents a significant step toward reducing treatment burden and could transform vision care for wet AMD patients.
Read Announcement- Drug:
- Ixo-vec
- Announced Date:
- August 1, 2024
- Indication:
- For the Treatment of Wet AMD
Announcement
Adverum Biotechnologies, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Ixo-vec, its clinical-stage gene therapy product candidate, for the treatment of wet AMD.
AI Summary
Adverum Biotechnologies announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its clinical-stage gene therapy candidate, Ixo-vec, targeted for the treatment of wet age-related macular degeneration (AMD). This designation recognizes the promising clinical data and the potential of Ixo-vec to transform how wet AMD is treated. It is designed as a one-time intravitreal injection that could offer long-lasting benefits and reduce the frequent injections required by current therapies. The RMAT status provides Adverum with intensive FDA guidance, potential priority review, and opportunities to expedite the development and review processes. This advancement reinforces the company’s commitment to developing innovative, one-time treatments that meet significant unmet needs for patients suffering from this sight-threatening condition.
Read Announcement
Adverum Biotechnologies FDA Events - Frequently Asked Questions
As of now, Adverum Biotechnologies (ADVM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Adverum Biotechnologies (ADVM) has reported FDA regulatory activity for Ixo-vec.
The most recent FDA-related event for Adverum Biotechnologies occurred on September 22, 2025, involving Ixo-vec. The update was categorized as "Provided Update," with the company reporting: "Adverum Biotechnologies, Inc announced it has notified sites that it plans to complete screening in ARTEMIS, its first pivotal Phase 3 trial evaluating Ixo-vec in wet age-related macular degeneration (wet AMD) by September 30, seven months after initiation, because the company now expects full enrollment of at least 284 treatment-naïve and treatment experienced patients in 4Q 2025 and data readout in 1Q 2027."
Currently, Adverum Biotechnologies has one therapy (Ixo-vec) targeting the following condition: For the Treatment of Wet AMD.
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FDA Event Stage Terminology & Abbreviation Guide
- 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
FDA progress for NASDAQ:ADVM last updated on 9/22/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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