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
ANX005 and ANX007. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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- Drug:
- ANX005
- Announced Date:
- June 25, 2024
- Indication:
- Huntington’s Disease (HD)
Announcement
Annexon, Inc. announced positive results from the completed pivotal Phase 3 trial of C1q-targeted immunotherapy, ANX005, in Guillain-Barré Syndrome (GBS) at the 2024 Peripheral Nerve Society (PNS) Annual Meeting in Montréal, Canada. Leading global experts in the GBS field highlighted the significant unmet need and opportunity to transform the GBS treatment landscape with a targeted immunotherapy approach, as well as additional Phase 3 analyses of early and durable treatment effects important to patients and the medical community.
AI Summary
Annexon, Inc. recently announced positive results from its pivotal Phase 3 trial studying the C1q-targeted immunotherapy ANX005 in patients with Guillain-Barré Syndrome (GBS). The trial showed that ANX005 treatment led to faster and more complete recovery compared to placebo, with many patients returning to a normal state of health much earlier. The findings were presented at the 2024 Peripheral Nerve Society Annual Meeting in Montréal, Canada.
Leading global experts in the GBS field highlighted the significant unmet need for improved treatments and the opportunity to transform the current approach with this targeted immunotherapy. Additional Phase 3 analyses confirmed early and sustained treatment benefits, which are essential for both patients and healthcare providers. These results support ANX005’s potential to become the first approved targeted immunotherapy for GBS.
Read Announcement- Drug:
- ANX005
- Announced Date:
- June 18, 2024
- Indication:
- Huntington’s Disease (HD)
Announcement
Annexon, Inc. announced the Company will have several presentations on the Company's ANX005 Guillain-Barré Syndrome (GBS) program at the 2024 Peripheral Nerve Society (PNS) Annual Meeting being held June 22-25, 2024 at the Palais des congrès de Montréal in Montréal, Canada.
AI Summary
Annexon, Inc. announced that it will feature several presentations on its ANX005 Guillain-Barré Syndrome (GBS) program at the 2024 Peripheral Nerve Society Annual Meeting. The meeting is scheduled for June 22–25, 2024, at the Palais des congrès de Montréal in Montréal, Canada.
During the event, Annexon will showcase pivotal Phase 3 clinical results of ANX005 in GBS. The presentations include a plenary session discussing early and durable treatment effects, a flash oral presentation comparing ANX005 to current treatments, and two poster sessions that explore various outcomes in different GBS patient populations. Additionally, an Annexon-sponsored lunch symposium will highlight the company’s efforts in breaking new ground in the treatment landscape for GBS. These sessions are designed to offer insights into the potential of ANX005 as a targeted therapy to rapidly reduce inflammation, promote nerve recovery, and help patients regain independence.
Read Announcement- Drug:
- ANX005
- Announced Date:
- June 4, 2024
- Indication:
- Huntington’s Disease (HD)
Announcement
Annexon, Inc. nnounced positive topline results from its randomized placebo-controlled pivotal Phase 3 trial in patients with Guillain-Barré syndrome (GBS).
AI Summary
Annexon, Inc. announced positive topline results from its randomized, placebo-controlled pivotal Phase 3 trial in patients with Guillain-Barré syndrome (GBS). A single infusion of ANX005 at 30 mg/kg met the primary endpoint, delivering a 2.4-fold improvement on the GBS-disability scale at week 8 with strong statistical significance (p = 0.0058). The trial showed that early treatment with ANX005 led to rapid target engagement, early and sustained improvements in muscle strength, and reduced nerve damage. Patients receiving ANX005 also spent fewer days on artificial ventilation and were able to walk independently about a month earlier than those who received a placebo. Overall, ANX005 was generally well-tolerated and showed promise as a targeted treatment for GBS, a serious and rapidly progressing neurological disorder that currently has no FDA-approved therapies.
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:
- 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
- Estimated Event Date Range:
- July 1, 2026 - December 31, 2026
- Target Action Date:
- H2 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
- Estimated Event Date Range:
- July 1, 2026 - December 31, 2026
- Target Action Date:
- H2 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- Drug:
- ANX007
- Announced Date:
- July 11, 2024
- Indication:
- Geographic Atrophy
Announcement
Annexon, Inc. announced the Company will have two presentations at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting being held July 17-20, 2024 in Stockholm, Sweden.
AI Summary
Annexon, Inc. announced that it will have two presentations at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting, which will be held from July 17-20, 2024 in Stockholm, Sweden. The company’s presentations will focus on the impact of its experimental drug ANX007 on visual acuity and retinal structure in patients with geographic atrophy.
One presentation, scheduled for July 18, 2024, at 8:42 am ET during the Imaging Symposium, will feature Dr. Glenn J. Jaffe discussing the protective effects of ANX007 on the central macula. Later that day, at 1:36 pm ET in the Dry AMD Symposium, Dr. Joel Pearlman will share clinical results indicating that ANX007 may preserve vision and retinal integrity based on Phase 2 ARCHER trial data.
Read Announcement
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