This company has been marked as potentially delisted and may not be actively trading. Adverum Biotechnologies (ADVM) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsEarningsFDA EventsHeadlinesInsider TradesOwnershipTrendsBuy This Stock Adverum Biotechnologies' Drug in the FDA Approval ProcessThis 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 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. Provided Update - September 22,2025Provided Update Phase 3Drug: Ixo-vecAnnounced Date: September 22, 2025Indication: For the Treatment of Wet AMDAnnouncementAdverum 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 SummaryAdverum 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 AnnouncementStudy Initiation - March 3,2025Study Initiation Phase 3Drug: Ixo-vecAnnounced Date: March 3, 2025Indication: For the Treatment of Wet AMDAnnouncementAdverum Biotechnologies, Inc. announced the initiation of the ARTEMIS Phase 3 study.AI SummaryAdverum 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 Adverum Biotechnologies FDA Events - Frequently Asked Questions Has Adverum Biotechnologies received FDA approval? As of now, Adverum Biotechnologies (ADVM) has not received any FDA approvals for its therapy in the last two years. What drugs has Adverum Biotechnologies submitted to the FDA? In the past two years, Adverum Biotechnologies (ADVM) has reported FDA regulatory activity for Ixo-vec. What is the most recent FDA event for Adverum Biotechnologies? 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." What conditions do Adverum Biotechnologies' current drugs treat? Currently, Adverum Biotechnologies has one therapy (Ixo-vec) targeting the following condition: For the Treatment of Wet AMD. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Fate Therapeutics FDA EventsLantheus FDA EventsAgenus FDA EventsBiomea Fusion FDA EventsMiNK Therapeutics FDA EventsRigel Pharmaceuticals FDA EventsBristol Myers Squibb FDA EventsAligos Therapeutics FDA EventsAnnexon FDA EventsAlterity Therapeutics FDA EventsCullinan Therapeutics FDA EventsDefinium Therapeutics FDA EventsFreenome FDA EventsAthira Pharma FDA EventsNeurocrine Biosciences FDA Events 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 Related Companies Rocket Pharmaceuticals FDA Events Upstream Bio FDA Events Agenus FDA Events Century Therapeutics FDA Events Prelude Therapeutics FDA Events Compass Therapeutics FDA Events Akebia Therapeutics FDA Events DiaMedica Therapeutics FDA Events Lyell Immunopharma FDA Events Organogenesis FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:ADVM last updated on 9/22/2025 by MarketBeat.com Staff. 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Provided Update - September 22,2025Provided Update Phase 3Drug: Ixo-vecAnnounced Date: September 22, 2025Indication: For the Treatment of Wet AMDAnnouncementAdverum 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 SummaryAdverum 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
Study Initiation - March 3,2025Study Initiation Phase 3Drug: Ixo-vecAnnounced Date: March 3, 2025Indication: For the Treatment of Wet AMDAnnouncementAdverum Biotechnologies, Inc. announced the initiation of the ARTEMIS Phase 3 study.AI SummaryAdverum 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
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