ANNX

Topline Pivotal Phase 3 Data for Vonaprument for the Treatment of Geographic Atrophy (GA) Expected Q4 2026, with Potential to Redefine Vision Preservation in GA Tanruprubart EU Marketing Authorization Application (MAA) Under Review as the Potentially First Targeted Therapy for Guillain-Barré Syndrome (GBS); Biologics License Application (BLA) Submission with U.S./European FORWARD Data Expected in 2026 Proof-of-Concept (POC) Data for ANX1502, a First-in-Kind Oral C1 Inhibitor for Autoimmune Disease, Expected in 2026 Strong Balance Sheet with Cash, Cash Equivalents and Short-Term Investments of Approximately $225 Million as of March 31, 2026, and Anticipated Runway into Second Half 2027 BRISBANE, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today highlighted portfolio progress, announced key anticipated milestones, and reported first quarter 2026 financial results. “As we execute toward major milestones in 2026, we are sharply focused on our strategic priorities across the organization,” said Douglas Love, president and chief executive officer of Annexon. “In GA, where no vision-preserving therapies are available for the approximately 8 million people impacted worldwide, we’re eagerly anticipating topline pivotal data from our ARCHER II Phase 3 trial in the fourth quarter of the year. ARCHER II is designed to reproduce the ARCHER Phase 2 data where vonaprument demonstrated the preservation of photoreceptor neurons and vision on multiple measures. In GBS, a debilitating rare disease and leading cause of acute neuromuscular paralysis that can strike anyone, any time and anywhere, our EU MAA for tanruprubart is under review for approval as the potentially first targeted therapy for the treatment of GBS. Enrollment continues in our U.S./EU FORWARD study, which is designed to broaden experience across western geographies to support our planned BLA submission in 2026. Finally, our POC study for ANX1502, a first-in-kind oral inhibitor designed to treat a host of neuromuscular diseases, is ongoing with data anticipated in 2026. With a bold mission to address neuroinflammatory diseases for millions worldwide, and a strong balance sheet powering us through several upco...

ARCHER II Topline Pivotal Phase 3 Data in Geographic Atrophy (GA) Expected Q4 2026; Vonaprument has Potential to Be the First Vision-Preserving Therapy for GA Tanruprubart MAA Filed in Europe with Potential to Be the First Targeted Fast-Acting Therapy for Guillain-Barré Syndrome (GBS); U.S./European FORWARD Study Data Expected to Support Planned BLA Submission in 2026 ANX1502 Advancing as First Oral C1 Inhibitor for Autoimmune Disease; Proof-of-Concept (POC) Data Anticipated in 2026 Strong Balance Sheet with Cash, Cash Equivalents and Short-Term Investments of Approximately $238.3 Million as of December 31, 2025, and Anticipated Runway into Second Half 2027 BRISBANE, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at neuroinflammatory diseases that impact nearly 10 million people worldwide, today highlighted portfolio progress, announced key anticipated milestones, and reported fourth quarter and full year 2025 financial results. “We’re energized by this defining period for Annexon. Two decades of C1q and classical complement pathway research have enabled our bold mission of pioneering a new class of targeted immunotherapies that reshape how neuroinflammation is treated. Today, our scientific platform has translated into two late stage registrational programs with the potential to improve the lives of millions in large, underserved markets worldwide,” said Douglas Love, president and chief executive officer of Annexon. “Leveraging one mechanism to stop neuroinflammation at its source, vonaprument is designed to protect photoreceptor neurons to preserve vision in GA, while tanruprubart is designed to protect peripheral nerves to support faster, more complete and durable recovery in GBS.” Mr. Love continued, “Grounded in robust vonaprument Phase 2 ARCHER data and strong execution of the ongoing Phase 3 ARCHER II trial, we are on track to report topline pivotal data in the fourth quarter of this year. ARCHER II is the first study to evaluate visual preservation as the primary endpoint in patients with GA and the first pivotal study with an aligned global regulatory path. Additionally, we have filed for Marketing Authorization Application (MAA) in the EU for tanruprubart and are preparing for potential approval of the first targeted thera...

Late-Stage Neuroinflammation Platform Advancing Global Registrational Programs in Guillain-Barré Syndrome (GBS) and Geographic Atrophy (GA) Current Tanruprubart GBS Dossier On Track for MAA Filing in January 2026; Potential to Be the First Approved Targeted and Fast-Acting Therapy for the Treatment of GBS; Continued FDA Discussions Regarding Generalizability Package in Support of BLA Filing Topline ARCHER II Pivotal Data for Vonaprument in Dry AMD with GA on Track for Second Half of 2026; Potential to Be the First Approved Vision Sparing Therapy for the Treatment of Eight Million GA Patients Worldwide ANX1502 Cold Agglutinin Disease (CAD) Proof of Concept Study Ongoing with Expected 2026 Completion; Potential to Be the Only Oral C1s Inhibitor for the Treatment of Multiple Neuroinflammatory Autoimmune Diseases Strong Financial Position and Execution Extends Operations into 2027, Through Several Important Milestones, Including Tanruprubart Global GBS Filings, Vonaprument Topline GA Phase 3 Data, and ANX1502 Autoimmune Proof of Concept Data BRISBANE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform targeting neuroinflammation across life-changing complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress, announced key anticipated milestones and reported third quarter 2025 financial results. “We’re pleased with the focused execution of our business strategy across our late-stage neuroinflammation platform, and the strong momentum we’ve built over 2025 heading into a meaningful 2026. Our next-generation complement inhibitor candidates continue to demonstrate the power of stopping neuroinflammation at its source, enabling multiple programs advancing toward key near-term milestones,” said Douglas Love, president and chief executive officer of Annexon. “Our registrational Guillain-Barré Syndrome program is on track for EU Marketing Authorisation Application (MAA) submission in January 2026, positioning it to become the first targeted therapy for GBS, a disease that annually affects 150,000 people worldwide. Dialogue with the FDA is also ongoing regarding the generalizability package supporting the U.S. Biologics License Application (BLA) submission. Furthermore, our registrational Phase 3 trial for vonaprument in GA is on...

Tanruprubart (formerly ANX005) for GBS Advancing Through Regulatory Interactions; MAA Submission in Europe Anticipated in First Quarter of 2026; Ongoing Discussions with FDA Regarding Generalizability Package to Support a BLA Accelerated Completion of Enrollment for Global Phase 3 ARCHER II Trial of Vonaprument (formerly ANX007) for Dry AMD with GA; Selected for EMA PRIME Product Development Candidate Pilot; Topline ARCHER II Data Expected in Second Half of 2026 ANX1502 First-in-Kind Oral C1s Inhibitor Exposure Exceeded Target Concentration in Fasted Patients; Evaluation in Relation to Food Intake Ongoing in Proof-of-Concept CAD Study, Update Expected by Year-end 2025 $227 Million in Cash Supports Operations into the Fourth Quarter of 2026 Through Vonaprument Topline Phase 3 Data in GA BRISBANE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress, announced key anticipated milestones and reported second quarter 2025 financial results. “We are well positioned to achieve our mission of helping millions of people with devastating complement-mediated diseases live their best lives by the consistent validation generated by our innovative C1 platform across multiple potential best-in-class therapeutics,” said Douglas Love, president and chief executive officer of Annexon. “In Guillain-Barré Syndrome (GBS), approximately 90% of tanruprubart-treated patients improved by week 1 and more than twice as many patients achieved a normal state of health at week 26 vs. placebo in our Phase 3 study. As a result, we are actively engaged in global regulatory interactions to bring tanruprubart to patients worldwide, which includes preparing to submit our Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first quarter of 2026. In parallel, we are also working with the Food and Drug Administration (FDA) to gain clarity on the generalizability package to support a Biologics License Application (BLA) submission.” Mr. Love continued, “We are also increasingly excited by the positive momentum of vonaprument for dry age-related macular degeneration (AMD) with geographic atrophy (GA), ex...

FDA Meeting for Tanruprubart (formerly ANX005), the First Potential Targeted Therapy for GBS, Scheduled for Second Quarter 2025 Ahead of Planned BLA Submission Open-Label Tanruprubart FORWARD Study Designed to Broaden Patient and Healthcare Community Experience in North America and Europe, Initiating in Second Quarter 2025 Accelerated Enrollment in Phase 3 ARCHER II Trial on Pace for Completion in Third Quarter 2025 for ANX007, the First Potential Treatment for Dry AMD with GA; Pivotal Topline Data Expected in the Second Half of 2026 Completion of Proof-of-Concept Trial for First-in-Kind Oral C1s Inhibitor ANX1502 in Cold Agglutin Disease Anticipated Mid-2025; Potential to Disrupt the Current Treatment of Antibody-Mediated Autoimmune Diseases $263.7 million in Cash, Cash Equivalents, and Short-term Investments as of March 31, 2025 Funds Late-Stage Milestones for Lead Programs and Anticipated Runway into Second Half 2026 BRISBANE, Calif., May 12, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress and reported first quarter 2025 financial results. “Our innovative C1 platform has yielded multiple wholly owned late-stage programs that have been shown to stop harmful neuroinflammation and lead to positive outcomes for patients across an array of diseases,” said Douglas Love, president and chief executive officer of Annexon. “Our most advanced program, tanruprubart, is approaching filing for the treatment of Guillain-Barré Syndrome (GBS) having consistently demonstrated rapid and sustained functional improvements in multiple placebo-controlled trials. Given the decades-long void of innovation, GBS remains a high unmet need without FDA-approved therapies or substantial evidence of effectiveness from the current standard of care, and we are eager to continue our dialogue with the FDA during our upcoming meeting this quarter in advance of our planned BLA submission. Furthermore, we are excited for the launch this quarter of the open-label FORWARD study designed to provide North American and European physicians and patients investigational access and experience with tanruprubart’s single infusion approach to tackling GBS.”...