Annexon (ANNX) has upcoming FDA regulatory milestones for ANX007. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Annexon (ANNX).
Over the past two years, Annexon has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
vonaprument, ANX1502, ANX007, and ANX005. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Vonaprument FDA Regulatory Events
Vonaprument is a drug developed by Annexon for the following indication: patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA).
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:
- vonaprument
- Announced Date:
- July 14, 2026
- Indication:
- patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA).
Announcement
Annexon, Inc. announced an oral presentation on the neuroprotective effect of vonaprument at the American Society of Retina Specialists (ASRS) 44th Annual Scientific Meeting being held July 15–18, 2026 in Montréal, Québec, Canada.
AI Summary
Annexon, Inc. announced an oral presentation at the American Society of Retina Specialists (ASRS) 44th Annual Scientific Meeting, taking place July 15–18, 2026, in Montréal, Québec, Canada. The presentation will focus on baseline characteristics linked to a loss of 15 or more ETDRS letters in best corrected visual acuity among participants with geographic atrophy in the Phase 2 ARCHER study.
The talk is scheduled for Saturday, July 18, 2026, at 10:44 a.m. EDT. It will be presented by Margaret Chang, M.D., M.S., of Retinal Consultants Medical Group. The announcement highlights Annexon’s work on the neuroprotective effect of vonaprument in eye disease research.
Read Announcement
ANX1502 FDA Regulatory Events
ANX1502 is a drug developed by Annexon for the following indication: ANX1502 suppressed C4d serum levels.
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:
- ANX1502
- Announced Date:
- January 12, 2026
- Indication:
- ANX1502 suppressed C4d serum levels
Announcement
Annexon, Inc. today highlighted its 2026 strategic priorities and key milestones for its lead programs.
AI Summary
Annexon outlined its 2026 strategic priorities and key milestones for its lead programs, emphasizing two registrational candidates and a strong balance sheet that funds operations into late 2027. The company is focused on advancing therapies that aim to stop neuroinflammation and protect function in serious diseases.
Vonaprument is positioned as a potential first targeted, vision‑preserving therapy for dry AMD with geographic atrophy. The global Phase 3 ARCHER II trial completed enrollment of 659 patients ahead of schedule; topline results are expected in the second half of 2026. Annexon will host a GA Investor Day in March 2026 to present program details and expert perspectives.
Tanruprubart has an MAA filed in Europe and an ongoing FORWARD study in the U.S. and Europe to support a broad label; a BLA submission with U.S./European FORWARD data is planned for 2026. ANX1502, an oral C1 inhibitor, aims to deliver proof‑of‑concept data in cold agglutinin disease in 2026.Read Announcement
ANX007 FDA Regulatory Timeline and Events
ANX007 is a drug developed by Annexon for the following indication: Geographic Atrophy.
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:
- ANX007
- Announced Date:
- July 24, 2025
- Indication:
- Geographic Atrophy
Announcement
Annexon, Inc. announced complete enrollment of the Phase 3 ARCHER II trial of vonaprument (formerly ANX007) for dry age-related macular degeneration (AMD) with geographic atrophy (GA), and the company remains on track to report topline data in the second half of 2026.
AI Summary
Annexon, Inc. announced it has fully enrolled its global Phase 3 ARCHER II trial of vonaprument (formerly ANX007) to treat dry age-related macular degeneration with geographic atrophy. The study, which surpassed its goal of 630 participants, will test the drug’s ability to preserve vision by measuring best corrected visual acuity and structural eye changes over at least 12 months.
The randomized, double-masked, sham-controlled trial compares monthly vonaprument injections against a sham procedure. Results from the primary endpoint, prevention of significant vision loss, and secondary measures like low-luminance acuity and retinal structure will support potential approval paths in the U.S. and Europe.
Annexon remains on track to report topline data in the second half of 2026. If successful, vonaprument could become the first treatment approved for dry AMD with geographic atrophy, offering hope for patients facing progressive vision loss.
Read Announcement- Drug:
- ANX007
- Announced Date:
- May 7, 2025
- Indication:
- Geographic Atrophy
Announcement
Annexon, Inc. announced presentations on the neuroprotective effect of ANX007, including consistent benefits of C1q inhibition against inflammation and neuronal damage across diseases.
AI Summary
Annexon, Inc. recently highlighted the progress of ANX007, a novel treatment designed to block C1q – a key trigger of inflammation and neuronal damage. The company announced presentations on the neuroprotective effects of ANX007 at major ophthalmology conferences. Researchers will show how C1q inhibition helps fight inflammation and prevent cell loss, a common issue in several diseases affecting vision and brain health. Early findings indicate that by blocking C1q, ANX007 offers consistent benefits in protecting against inflammation and neuronal damage. This approach may open new possibilities for preserving vision in patients with dry age-related macular degeneration and geographic atrophy, both of which can lead to severe vision loss. The upcoming discussions will help scientists and clinicians understand the potential impact of this innovative therapy across multiple conditions.
Read Announcement- Drug:
- ANX007
- Announced Date:
- February 13, 2025
- Indication:
- Geographic Atrophy
Announcement
Annexon, Inc. announced presentations on ANX007 in geographic atrophy (GA) at the Macula Society 48th Annual Meeting being held February 12-15 in Charlotte Harbor, Florida.
AI Summary
Annexon, Inc. announced that it will present important data on its novel therapy ANX007 for geographic atrophy (GA) at the Macula Society 48th Annual Meeting in Charlotte Harbor, Florida, from February 12-15, 2025. ANX007 is a new treatment developed to block C1q locally in the eye. It is designed to protect vision in patients with GA by preventing damage to key retinal cells. Two presentations are scheduled during the meeting. Dr. Rahul Khurana will discuss how the treatment helps protect visual acuity and the central retina in the ongoing Phase 2 ARCHER Trial, while Dr. Eleonora Lad will explain how blocking C1q may reduce neuronal injury caused by microglia. This exciting development could lead to a new approach for preserving vision in people with this serious eye disease.
Read Announcement- Drug:
- ANX007
- Announced Date:
- January 13, 2025
- Indication:
- Geographic Atrophy
Announcement
Annexon, Inc. announced its 2025 outlook and key catalysts for its flagship programs: ANX005 in Guillain-Barré syndrome (GBS), ANX007 in geographic atrophy (GA), and oral small molecule ANX1502 for a host of diseases.
AI Summary
Annexon, Inc. has unveiled its 2025 outlook, highlighting key catalysts for its flagship programs. The company’s ANX005, aimed at treating Guillain-Barré syndrome, is positioned to become the first targeted therapy to rapidly improve muscle strength and restore function. Announced plans include a Biologics License Application (BLA) submission in the first half of 2025, marking an important milestone against current standard care.
Another focus is on ANX007 for geographic atrophy, a condition linked to vision loss. Its Phase 3 ARCHER II trial is progressing well, with patient enrollment expected to complete in the second half of 2025, building on promising proof-of-concept data. Additionally, ANX1502, the first oral C1s inhibitor, is advancing toward clinical proof-of-concept data in the first quarter of 2025, offering a potential new treatment for a range of autoimmune diseases. These key programs underscore Annexon’s commitment to transforming treatments for neuroinflammatory disorders.
Read Announcement- Drug:
- ANX007
- Announced Date:
- December 5, 2024
- Target Action Date:
- H2 2026
- Estimated Target Date Range:
- July 1, 2026 - December 31, 2026
- Indication:
- Geographic Atrophy
Announcement
Annexon, Inc. Pivotal Phase 3 ARCHER II in GA Actively Enrolling with Data Expected Second Half 2026
AI Summary
Annexon, Inc. has started enrolling patients in its pivotal Phase 3 ARCHER II trial for geographic atrophy (GA), a severe form of dry age-related macular degeneration (AMD). The global, randomized, double-masked, sham-controlled study plans to include about 630 patients who will be assigned in a 2:1 ratio to receive either monthly doses of ANX007 or a sham procedure. ANX007 is designed to block the protein C1q in the eye, potentially halting vision loss by preserving photoreceptors, especially in the fovea region that is critical for sharp vision. The primary endpoint is to prevent a loss of 15 letters or more in best corrected visual acuity (BCVA), a significant marker for vision decline. Topline data from the trial are expected in the second half of 2026, offering important insights into the therapy’s ability to protect vision in patients with GA.
Read Announcement- Drug:
- ANX007
- Announced Date:
- December 5, 2024
- Indication:
- Geographic Atrophy
Announcement
Annexon, Inc. announced the company will present analyses of ANX007 from the completed Phase 2 ARCHER trial in geographic atrophy (GA) at the Floretina-ICOOR 2024 meeting being held December 5-8 in Florence, Italy.
AI Summary
Annexon, Inc. announced it will present new analyses of its drug candidate ANX007 at the upcoming Floretina-ICOOR 2024 meeting in Florence, Italy from December 5 to 8. The company will share detailed findings from the completed Phase 2 ARCHER trial in patients with geographic atrophy, a form of dry age-related macular degeneration. Presentations will cover how ANX007, a first-in-class non-pegylated antigen-binding fragment, appears to protect vision by preserving photoreceptors. Experts at the meeting will discuss data showing that ANX007 blocks C1q—a protein that triggers inflammation and neurodegeneration in the eye—which may help maintain visual acuity and protect key retinal structures. This analysis aims to further clarify the relationship between the drug’s structure, function, and its potential as a promising treatment option for patients with GA.
Read Announcement- Drug:
- ANX007
- Announced Date:
- September 9, 2024
- Target Action Date:
- H2 2026
- Estimated Target Date Range:
- July 1, 2026 - December 31, 2026
- Indication:
- Geographic Atrophy
Announcement
Annexon, Inc. announced that ARCHER II Phase 3 Pivotal Program in GA Underway with Data Expected Second Half 2026
AI Summary
Annexon, Inc. announced that its Phase 3 ARCHER II pivotal trial for geographic atrophy (GA) is now underway. This advancement follows promising results from the Phase 2 ARCHER trial, where ANX007 demonstrated significant vision protection in both standard and low light conditions and helped preserve photoreceptors in the fovea, a critical region for visual acuity.
The new trial aims to confirm whether ANX007 can slow vision loss in patients with GA by locally blocking the C1q protein. The company expects to have data from the ARCHER II trial by the second half of 2026. This effort represents a major step forward in the search for an effective treatment for GA and offers hope to those affected by this challenging eye condition.
Read Announcement - Drug:
- ANX007
- Announced Date:
- September 9, 2024
- Indication:
- Geographic Atrophy
Announcement
Annexon, Inc. announced the Company will present analyses of ANX007 from the completed Phase 2 ARCHER trial in geographic atrophy (GA) at the Retina Society's 57th annual scientific meeting being held September 11-15 in Lisbon, Portugal, and at the 24th annual Euretina Congress being held September 19–22 in Barcelona, Spain.
AI Summary
Annexon, Inc. announced that it will share new analyses from its completed Phase 2 ARCHER trial evaluating ANX007 for geographic atrophy (GA). The company plans to present these findings at two key upcoming events. Specifically, the data will be discussed at the Retina Society’s 57th Annual Scientific Meeting in Lisbon, Portugal from September 11-15, and again during the 24th Annual Euretina Congress in Barcelona, Spain from September 19-22.
The presentations will showcase how ANX007 has demonstrated significant protection of vision, preserving sight in both standard and low light conditions, as well as protecting photoreceptors in the fovea—a critical area for visual acuity. These promising results support ANX007’s potential as a transformative treatment for GA and pave the way for the ongoing Phase 3 ARCHER II pivotal trial with data expected in the second half of 2026.
Read Announcement
ANX005 FDA Regulatory Timeline and Events
ANX005 is a drug developed by Annexon for the following indication: Huntington’s Disease (HD).
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:
- ANX005
- Announced Date:
- May 19, 2025
- Indication:
- Huntington’s Disease (HD)
Announcement
Annexon, Inc. today presented oral and poster presentations highlighting improved outcomes with tanruprubart (formerly ANX005) at the 2025 Peripheral Nerve Society (PNS) Annual Meeting being held May 17-20, 2025 in Edinburgh, UK.
AI Summary
At the 2025 Peripheral Nerve Society Annual Meeting in Edinburgh, UK, Annexon, Inc. presented both oral and poster presentations highlighting improved outcomes with tanruprubart (formerly ANX005). The data showcased how this novel monoclonal antibody can offer a rapid and sustained improvement in patients suffering from Guillain‑Barré Syndrome (GBS). In the presentations, researchers showed that tanruprubart produced a quick gain in muscle strength compared to standard care treatments like IVIg and plasma exchange. Results indicated that patients receiving tanruprubart experienced early improvements as soon as Week 1, with these benefits maintained through Week 26. The evidence from both real-world studies and pivotal Phase 3 analyses suggests that tanruprubart has the potential to transform GBS treatment by quickly halting nerve damage and inflammation, thereby boosting recovery and enhancing quality of life for patients.
Read Announcement- Drug:
- ANX005
- Announced Date:
- May 9, 2025
- Indication:
- Huntington’s Disease (HD)
Announcement
Annexon, Inc. announced oral and poster presentations highlighting improved outcomes with tanruprubart (formerly ANX005) at the 2025 Peripheral Nerve Society (PNS) Annual Meeting at the Edinburgh International Conference Centre being held May 17-20, 2025 in Edinburgh, UK.
AI Summary
Annexon, Inc. recently announced that it will present both oral and poster sessions at the 2025 Peripheral Nerve Society Annual Meeting, held from May 17-20 at the Edinburgh International Conference Centre in Edinburgh, UK. These presentations focus on tanruprubart (formerly ANX005), a novel monoclonal antibody developed to block C1q, the molecule that starts the classical complement cascade. The therapy is designed to quickly halt neuroinflammation and nerve damage in Guillain-Barré Syndrome (GBS), a rapidly progressing neuromuscular disorder with no approved treatments. The oral presentation will share real-world evidence from the International Guillain-Barré Syndrome Outcomes Study showing improved outcomes with tanruprubart compared to current care standards. Poster presentations will highlight both early treatment effects and long-term improvements in quality of life by objectively linking early complement inhibition with better outcomes in GBS patients.
Read Announcement- Drug:
- ANX005
- Announced Date:
- April 8, 2025
- Indication:
- Huntington’s Disease (HD)
Announcement
Annexon, Inc. today presented data for its late-stage targeted therapy for GBS and showcased new disease education activities at the AAN Annual Meeting taking place April 5–9, 2025, in San Diego, California.
AI Summary
Annexon, Inc. presented promising Phase 3 data for tanruprubart (formerly ANX005), a late-stage targeted therapy for Guillain-Barré Syndrome (GBS), at the AAN Annual Meeting in San Diego from April 5–9, 2025. The oral presentation highlighted that a single infusion of tanruprubart showed rapid and durable clinical benefits. Patients experienced significant improvements in key functional measures such as muscle strength, mobility, and overall disability status compared to placebo. These findings underline the potential of this novel monoclonal antibody to rapidly block C1q and halt neuroinflammation in GBS.
Additionally, Annexon introduced Move GBS Forward™, a new disease education campaign aimed at healthcare professionals. This initiative seeks to raise awareness about the sudden onset and long-term impacts of GBS, emphasizing the need for prompt diagnosis and effective care to improve patient outcomes.
Read Announcement- Drug:
- ANX005
- Announced Date:
- April 3, 2025
- Indication:
- Huntington’s Disease (HD)
Announcement
Annexon, Inc. today highlights the company's leadership in advancing clinical research and education for GBS at the AAN Annual Meeting taking place April 5–9, 2025, in San Diego, California.
AI Summary
Annexon, Inc. is set to showcase its leadership in advancing clinical research and education for Guillain-Barré Syndrome (GBS) at the American Academy of Neurology (AAN) Annual Meeting in San Diego, California, from April 5–9, 2025. The company will display key findings from its placebo-controlled Phase 3 trial of ANX005, a promising, first-in-class monoclonal antibody, during an oral plenary session on April 8. This trial demonstrated rapid and lasting improvements in clinical measures for GBS patients. Additionally, Annexon will host an educational symposium focused on enhancing GBS care by discussing the role of the classical complement pathway and current patient care practices. The company is also launching the “Move GBS Forward” campaign, which aims to educate healthcare professionals about the serious physical and mental impacts of GBS, encouraging prompt diagnosis and treatment.
Read Announcement- Drug:
- ANX005
- Announced Date:
- December 16, 2024
- Indication:
- Huntington’s Disease (HD)
Announcement
Annexon, Inc. announced positive topline results from a real-world evidence (RWE) study supporting ANX005 as a potential treatment for Guillain-Barré Syndrome (GBS).
AI Summary
Annexon, Inc. recently announced positive topline results from a real-world evidence study, adding support to ANX005 as a potential treatment for Guillain-Barré Syndrome (GBS). The study compared 79 patients from their Phase 3 trial with 79 matched patients from the International GBS Outcomes Study (IGOS). Patients receiving ANX005, a targeted immunotherapy designed to rapidly block C1q and curb complement activity, showed faster and greater improvements in muscle strength and overall function compared to those treated with standard therapies such as intravenous immunoglobulin (IVIg) or plasmapheresis.
Additionally, fewer ANX005-treated patients needed mechanical ventilation, and those who did required it for a shorter time. These encouraging findings support the potential of ANX005 to alleviate the severe symptoms of GBS and guide future regulatory discussions, with a planned U.S. Biologics License Application submission in the first half of 2025.
Read Announcement
