Annexon, Inc. Stock Price, News & Analysis

Annexon (NASDAQ:ANNX) reported Q2 2025 financial results and pipeline updates for its complement-mediated disease therapies. The company ended Q2 with $227 million in cash, supporting operations into Q4 2026. Key highlights include:

For tanruprubart (GBS treatment): MAA submission in Europe planned for Q1 2026, with ongoing FDA discussions. About 90% of treated patients showed week 1 improvement, with twice as many achieving normal health vs placebo at week 26.

For vonaprument (dry AMD treatment): Completed enrollment of 659 patients in Phase 3 ARCHER II trial, with topline data expected in H2 2026. Selected for EMA's PRIME Product Development pilot.

Q2 2025 financials show R&D expenses of $44.2M (vs $25.0M in Q2 2024) and net loss of $49.2M ($0.34 per share) compared to $29.6M ($0.23 per share) in Q2 2024.

[ "Strong cash position of $227M supporting operations through Q4 2026", "90% of tanruprubart-treated GBS patients showed week 1 improvement, with 2x more achieving normal health vs placebo", "Accelerated enrollment completion of 659 patients in Phase 3 ARCHER II trial for vonaprument", "Selection for EMA PRIME Product Development Coordinator pilot program", "ANX1502 oral C1s inhibitor exceeded target concentration in fasted patients" ]

Annexon (NASDAQ:ANNX) announced that its drug candidate vonaprument has been selected by the European Medicines Agency (EMA) for the Product Development Coordinator (PDC) pilot program. Vonaprument, designed to treat dry age-related macular degeneration (AMD) with geographic atrophy (GA), is among approximately 20 PRIME development programs chosen for this initiative.

The drug has received PRIME designation in Europe and Fast Track Designation from the FDA. It is currently being evaluated in the ARCHER II Phase 3 trial, with topline data expected in H2 2026. Notably, vonaprument is the only investigational therapy in GA showing significant vision preservation in both best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA).

Annexon (NASDAQ:ANNX) has completed enrollment for its pivotal Phase 3 ARCHER II trial of vonaprument for dry age-related macular degeneration (AMD) with geographic atrophy (GA). The trial exceeded its target of 630 participants, demonstrating strong demand for vision-preserving therapy. Topline data is expected in H2 2026.

Vonaprument, a first-in-kind non-pegylated antigen-binding fragment, showed promising results in Phase 2 trials as the only investigational therapy demonstrating significant vision preservation through best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA). The drug has received PRIME designation in Europe and Fast Track designation in the U.S., positioning it to potentially become the first treatment approved in both regions for dry AMD with GA based on visual acuity protection.

Annexon (NASDAQ: ANNX) has appointed Dr. Lloyd Clark as SVP of ophthalmology strategy and innovation to advance their ANX007 program for dry Age-Related Macular Degeneration (AMD) with Geographic Atrophy (GA). Dr. Clark brings 25 years of experience as a retina specialist and has been principal investigator in over 70 clinical trials. ANX007, a non-pegylated Fab designed to block C1q locally in the eye, is the only investigational therapy shown to significantly preserve vision and central retinal photoreceptors in GA patients. The company's Phase 3 ARCHER II trial is expected to complete enrollment in Q3 2025, with topline data anticipated in H2 2026. Dry AMD with GA affects over 8 million patients globally with no approved therapies targeting vision preservation. Dr. Clark's appointment strengthens Annexon's expertise as they advance towards potential global registration of ANX007.

Annexon Biosciences (NASDAQ: ANNX), a biopharmaceutical company focused on developing novel therapies for classical complement-mediated neuroinflammatory diseases, has announced its participation in the upcoming Jefferies Global Healthcare Conference. Douglas Love, the company's president and CEO, will deliver a presentation on June 4, 2025, at 8:10 a.m. EST. Investors and interested parties can access the live webcast through the 'Events & Presentations' section on Annexon's investor relations website. The presentation recording will remain available for replay on www.annexonbio.com for 30 days after the event.

Annexon (NASDAQ: ANNX) presented promising clinical data for tanruprubart (formerly ANX005) at the 2025 PNS Annual Meeting. The drug, designed to treat Guillain-Barré Syndrome (GBS), showed significant improvements over current standard treatments. Key findings from the Real-World Evidence study demonstrated that tanruprubart-treated patients experienced a ten-point improvement in muscle strength over IVIg/PE-treated patients within Week 1, and were three times more likely to achieve better health outcomes at Weeks 4, 8, and 26. The Phase 3 trial analysis revealed that a single 30 mg/kg dose of tanruprubart effectively halted inflammation and nerve damage, leading to rapid improvements in muscle strength, mobility, and daily living activities. GBS, affecting 150,000 people worldwide annually, currently has no FDA-approved therapies. Tanruprubart could become the first targeted immunotherapy for GBS, potentially transforming the global treatment landscape.

Annexon (NASDAQ: ANNX) has granted stock options to two new non-executive employees as part of its 2022 Employment Inducement Award Plan. The equity awards, approved on May 14, 2025, include options to purchase 214,000 shares of Annexon common stock at an exercise price of $1.81 per share, matching the closing price on May 15, 2025. The options have a ten-year term and vest over 4 years, with 25% vesting after the first year and the remaining vesting monthly at 1/48th, contingent on continued employment.

Annexon (NASDAQ: ANNX) reported Q1 2025 financial results and highlighted progress across its late-stage clinical portfolio. The company's lead program tanruprubart is advancing towards BLA submission for Guillain-Barré Syndrome (GBS), with an FDA meeting scheduled for Q2 2025. The company is launching the open-label FORWARD study to provide North American and European access to tanruprubart.

Their second program, ANX007, is progressing in Phase 3 ARCHER II trial for dry AMD with geographic atrophy, with enrollment completion expected in Q3 2025 and topline data in H2 2026. The oral small molecule ANX1502 proof-of-concept trial in cold agglutinin disease is set to complete by mid-2025.

Financially, Annexon reported $263.7 million in cash and investments as of March 31, 2025, with runway into H2 2026. Q1 2025 net loss was $54.4 million ($0.37 per share), compared to $25.2 million ($0.21 per share) in Q1 2024.

Annexon (NASDAQ: ANNX) announced upcoming presentations at the 2025 Peripheral Nerve Society Annual Meeting highlighting improved outcomes with tanruprubart (formerly ANX005) for treating Guillain-Barré Syndrome (GBS). The presentations, scheduled for May 17-20, 2025 in Edinburgh, UK, will showcase comparative effectiveness data and new analyses from Phase 3 trials.

GBS is a rare autoimmune disease causing rapid weakness and potential paralysis, with no current FDA-approved treatments. Tanruprubart, a first-in-kind monoclonal antibody, targets C1q to block classical complement cascade initiation. The drug aims to halt neuroinflammation and nerve damage during acute GBS phase with a single infusion.

The presentations will include real-world evidence comparing tanruprubart to standard treatments, data linking early complement inhibition to long-term outcomes, quality of life improvements, and efficacy across a broad patient spectrum.